**The Cancer Centers Branch of the National Cancer Institute**

**Policies and Guidelines Relating to the Cancer Center Support Grant**

**September 2008**

**Table of Contents**

########  I. Cancer Center Program: Philosophy & Policies 4

Features of an NCI-designated Cancer Center 4

*Cancer Center versus Cancer Research Center* 4

*A Policy of Inclusion* 4

*Community Dissemination, Education and Information Activities* 5

*The Six Essential Characteristics of an NCI-designated Cancer Center* 5

NCI Designations 6

Consortium Centers 6

Major Research Areas and Interactions 7

*Transdisciplinary and Translational Interactions* 7

*Relation of the CCSG to the Cancer Center as a Whole* 8

*The Relationship of Centers to Each Other* 8

*Collaborations with NCI-funded Programs and Investigators* 8

*Interactions with Industry* 8

Budget and Funding Policies 9

*Time Limitations* 9

*Some Restrictions on Allowable Budgets* 9

*Competing Continuation (Type 2) Applications* 9

*First-time (Type 1) Applications* 9

*Competitive Supplemental Applications* 9

*Administrative Supplements* 10

*Sources of Budget Flexibility in a CCSG* 10

*Funding Policies* 10

########  II. Submission of New & Competing Continuation Applications for a Cancer Center Support Grant 12

########  Eligibility Requirements 12

########  *Only Research Institutions in the U.S. Are Eligible to Apply* 12

########  *Only One CCSG Application per Institution* 12

########  *Funding Base* 12

########  *Sources of Support That May Be Included for Determining Eligibility to Apply for a CCSG* 13

########  *Sources of Support That May Not be Included* 13

########  Key Dates in the Grant Application, Review and Funding Process 13

Pre-application Consultation 13

########  Formatting Instructions for New and Competing Continuation CCSG Applications 14

> *Page Limitations* 14
>
> *Letter of Agreement to Accept the Application* 14

1.0 *Face Page* 15

2.0 *Description, Performance Sites, and Key Personnel* 15

3.0 *Table of Contents* 15

4.0 *Consolidated and Summary Budget Request* 15

5.0 *Standard Cancer Center Information* 15

6.0 *History and Description of the Cancer Center Specifically
Describing the*

*Six Essential Characteristics of the Cancer Center* 16

> 6.1 Director's Overview 16
>
> 6.2 Six Essential Organizational and Administrative Characteristics 16

7.0 *Descriptions, Budgets, and Narrative Justifications for Individual
CCSG Components* 19

> 7.1 Senior Leadership 19
>
> 7.2 Leaders of Scientific Research Programs 20
>
> 7.3 Staff Investigators 20
>
> 7.4 Planning and Evaluation 20
>
> 7.5 Developmental Funds 21
>
> 7.6 Cancer Center Administration 23

8.0 *Research Programs* 24

8.1 Goals 24

8.2 Selection of Members 24

8.3 Characteristics of Programs 25

8.4 Definition of Peer-Reviewed, Funded Research Projects 25

8.5 Formatting for Each Program Section 26

9.0 *Shared Resources and Other Support Elements* 27

> 9.1 Shared Resources 27
>
> 9.2 Protocol Review and Monitoring System (PRMS) 33
>
> 9.3 Protocol-Specific Research Support 36

10.0 *Inclusion of Minorities and Women in Clinical Trials* 36

11.0 *Inclusion of Children in Clinical Trials* 37

12.0 *Data and Safety Monitoring* 38

13.0 *Federal Citations Relevant to CCSG Applications* 38

14.0 *Appendices* 40

15.0 *Review Materials to be Available before the Full or Limited Site
Visit* 40

16.0 *Application for Comprehensiveness* 41

16.1 First Stage Review for Comprehensiveness (Scientific Elements) 41

> 16.2 Second Stage Review for Comprehensiveness (Education and Training
> of Biomedi-
>
> cal Researchers and Professionals and Community Service and Outreach)
> 41
>
> 16.3 One-time Opportunity to Reapply for Comprehensiveness 43
>
> 16.4 Retaining the Comprehensive Designation 43

Instructions for Submitting the CCSG Application 43

*Where to Send the Application* 43

*Acceptance of the Application* 43

*Modifications After Submission* 44

*Inquiries About the Application After Submission* 44

######## III. Peer Review of the Application 45

Types of Review 45

*Full Site Visit Review* 45

*Limited Site Visit Reviews* 46

*Parent Committee Review* 46

*Ad hoc Review* 46

*National Cancer Advisory Board* 46

Criteria for Peer Review for Competing CCSG Applications 47

*Overview* 47

*Reviewing Science in the CCSG* 47

*Assessing Merit Despite Institutional Diversity* 47

*Some Restrictions on Allowable Budgets* 48

*Essential Characteristics of the Center* 48

*Senior Leadership* 50

*Planning and Evaluation* 50

*Developmental Funds* 51

*Staff Investigators* 51

*Scientific Quality of Each Program* 51

*Overall Quality of the Programs* 52

*Center Administration* 52

*Shared Resources and Services* 53

*Protocol Review and Monitoring System* 53

*Protocol Specific Research Support* 54

*Data and Safety Monitoring Plan* 54

*Minority and Gender Representation* 54

*Inclusion of Children in Clinical Trials* 54

*Overall Merit Rating of the Cancer Center* 54

*Duration* 55

*Overall Budget Recommendation* 55

Criteria for Comprehensiveness 55

*Stage I, Scientific Elements* 55

*Stage II, Education and Training of Biomedical Researchers* 55

*Stage II, Community Service, Outreach, and Dissemination* 55

**Policies and Guidelines Relating to the Cancer-Center Support Grant
(CCSG)**

######## I Cancer Centers Program: Philosophy & Policies

The NCI-designated Cancer Centers are the centerpiece of the nation's
effort to reduce morbidity and mortality from cancer. As a major source
of discovery of the nature of cancer, and of development of more
effective approaches to prevention, diagnosis, and therapy, they are
unparalleled by any other national effort in any disease area. Cancer
centers also deliver medical advances to patients and their families,
educate health-care professionals and the public, and reach out to
under-served populations. An excellent cancer center is a local,
regional, and national resource, directly serving its own community and,
through the knowledge it creates, the world at large.

NCI designed its cancer centers program to enhance the potential of
institutions for scientific discovery and its effective application to
patients and people at risk for cancer. The NCI-designated Cancer
Centers serve as models of transdisciplinary[^1] translational research
through development of clinical and public health interventions from
fundamental discoveries, and laboratory investigation of clinical and
population observations. To decrease cancer incidence and mortality,
centers link cancer research initiatives within the center to health
service delivery systems outside the center via proactive dissemination
programs, education of health-care professionals and the public, and
community partnerships. NCI expects that centers, particularly those
with the 'Comprehensive' designation, will develop effective research
dissemination strategies to eliminate the disproportionate burden of
cancer in minority and other underserved populations.

NCI support to cancer centers is intended to foster excellence in
research across a broad spectrum of scientific and medical concerns
relevant to cancer. To facilitate discovery and its translation into
direct benefit to patients and the general public, the NCI awards Cancer
Center Support Grants (CCSGs) to institutions that have a critical mass
of excellent cancer-relevant scientific research. The CCSG focus on
research derives from NCI's conviction that a culture of discovery;
scientific excellence; transdisciplinary research; and collaboration
engenders a cascade of tangible benefits extending far beyond the
generation of new knowledge.

######## Features of an NCI-designated Cancer Center

# Cancer Center *versus* Cancer Research Center: CCSG funding to cancer centers supports research infrastructure; other activities critical to a center's service mission are supported by patient revenues, philanthropy, and state or local government. NCI considered using the term "cancer research center" but chose "cancer center" to emphasize the close association within NCI-funded institutions of research and clinical care, education, and dissemination. Indeed their intimate association distinguishes NCI-designated Cancer Centers from other "cancer centers," which, whatever their credentials in delivery of medical care, generally lack a strong research base to drive discovery and the development of new approaches to disease prevention, detection, and treatment. Institutions lacking a research base follow by adopting advances developed elsewhere, but they cannot lead.

# A Policy of Inclusion: The purpose of an NCI-designated Cancer Center is to capitalize on all institutional cancer research and research dissemination capabilities. An institution or consortium of institutions with meritorious programs in laboratory, clinical, and population research must integrate these into a single transdisciplinary cancer center research enterprise across departmental, school, and institutional boundaries (e.g., Schools of Medicine, Public Health, Nursing, Dentistry, Allied Health, Veterinary Medicine, Engineering, and Pharmacy; Departments of Psychology, Psychiatry, Sociology, Nutrition, etc.). An institution having both basic and clinical activities, for example, may not submit a CCSG application focusing on basic or clinical research only. A major test of both institutional commitment and the quality of center leadership is to strengthen and integrate all major areas of research present within the institution(s), and to harmonize research with education and care. 

# Community Dissemination, Education and Information Activities: Cancer centers not only generate new knowledge but also interact within their communities to assure that new knowledge benefits systems, providers and people. Centers are expected to be active participants in state and community comprehensive cancer control planning and implementation. Centers assure that medical advances developed within the center are made available to people outside the center as rapidly as possible via professional and public education, as well as partnerships with public health or clinical service delivery systems. Centers support the translation of intervention programs into public health or clinical practice. The provision of cancer information within their communities; establishment of formal programs for teaching; development of screening, therapeutic and/or preventive interventions; participation of center faculty in science programs for nearby school districts; and collaboration with clinics in underserved areas are a few of the ways that centers extend their reach to patients, populations, and professionals who might otherwise not realize the benefits of scientific and medical advances. The strong interactions of NCI's cancer centers with their communities provide the relationships and organizational infrastructure required for conducting research that improves dissemination, education, and communication, and ultimately enhances the health of populations.

**The Six Essential Characteristics of an NCI-designated Cancer
Center:** Despite great institutional variety, the one common
denominator of all successful NCI-designated Cancer Centers is
excellence in research. Successful cancer centers have scientifically
strong research bases that are funded by peer-reviewed grants from the
NIH and other sources, and organized into formal, collaborative,
cancer-focused, scientific Programs. In addition to excellence in
research, a successful center is organized and administered to maximize
the potential of its research base so that the whole is greater than the
sum of its parts.

+-----------------------------------------------------------------------+
| **The Six Essential Characteristics of an NCI-designated Cancer       |
| Center**                                                              |
|                                                                       |
| # Facilities: Phys                                                    |
| ical facilities dedicated to the conduct of cancer focused research,  |
| and to the center's shared resources, administration, and research di |
| ssemination efforts, should be appropriate and adequate to the task.  |
|                                                                       |
| **Organizational Capabilities:** The center should be organized to    |
| take maximum advantage of institutional capabilities in cancer        |
| research, and to appropriately plan and evaluate center strategies    |
| and activities.                                                       |
|                                                                       |
| # Transdisciplinary Collaboration and Coo                             |
| rdination: Substantial coordination, interaction, and collaboration a |
| mong center members from a variety of disciplines should enhance and  |
| add value to the productivity and quality of research in the center.  |
|                                                                       |
| # Cancer Focus: A defined scientific focus on ca                      |
| ncer research should be clear from the center members' grants and con |
| tracts, and from the structure and objectives of its formal Programs. |
|                                                                       |
| # Institution                                                         |
| al Commitment: The center should be recognized as a formal organizati |
| onal component with sufficient space, positions, and discretionary re |
| sources to insure its stability and fulfill the center's objectives.  |
|                                                                       |
| **Center Director:** The director should be a highly qualified        |
| scientist and administrator with leadership experience and            |
| institutional authority appropriate to manage the center and further  |
| its scientific mission and objectives.                                |
+-----------------------------------------------------------------------+

##### 

##### 

##### NCI Designations

# Cancer centers have developed in many different organizational settings, reflecting considerable diversity in the size and complexity of their research emphases. Whether organized as a freestanding center, a center matrixed within an academic institution, or a formal research based consortium under centralized leadership, all centers are judged by the same scientific, organizational, and administrative criteria. NCI recognizes two general categories of centers:

-   A **cancer center** has a scientific agenda that is primarily
    focused on laboratory, clinical research, or population science or
    some combination of these components. Such centers are encouraged to
    stimulate transdisciplinary research. All areas of research should
    be linked collaboratively. Cancer centers with clinical components
    are *expected* to initiate and conduct investigator-initiated, early
    phase, innovative clinical trials and to provide leadership for, and
    participate in, the NCI cooperative groups.

##### A comprehensive cancer center demonstrates reasonable depth and breadth of research activities in *each* of three major areas: laboratory, clinical, and population-based research, with substantial transdisciplinary research that bridges these scientific areas. A comprehensive cancer center is expected to initiate and conduct investigator-initiated, early phase, innovative clinical trials and to provide leadership for, and participate in the NCI cooperative groups. An NCI-designated Comprehensive Cancer Center must also demonstrate community service, outreach, and dissemination; and education and training of biomedical researchers and health care professionals.

##### Consortium Centers

Cancer centers have become more complex as mergers and strategic
alliances blur long-familiar institutional identities. NCI supports
consortium centers, in which investigators from separate but partnering
scientific institutions contribute actively to the development and
actualization of the cancer research agenda; these formalized
relationships have the potential not only to strengthen the science of
the center as whole, but also to extend the benefits of cancer research
beyond existing borders. Consortium centers demonstrate a high level of
scientific engagement and interaction, with each member institution
adding strategic value to the research mission. At the time of
submission consortium applications must demonstrate integrated research
(as evidenced by a history of collaboration, including authorship of
grants and publications) and mechanisms for including geographically
dispersed members in programmatic activities and ensuring access to
shared resources. Partnerships between research institutions serving
special populations or located in geographic areas not currently served
by an NCI-designated Cancer Center are particularly encouraged. Common
fundraising and a joint Internal Review Board for evaluation of all
cancer research across the partner institutions are encouraged, but not
required. Formal written agreements should be in place to ensure the
stability and integration of the consortium partnership, including:

-   resolution of differences at the highest levels of institutional
    leadership.

-   a single Protocol Review and Monitoring System and Data and Safety
    Monitoring Institutional Plan governing cancer clinical trial
    protocols across all partner institutions.

-   an integrated recruitment process to meet the strategic goals of the
    center.

-   Uniform availability of the benefits of clinical research across all
    consortium institutions.

-   full eligibility for leadership positions, participation in formal
    scientific Programs (see Part II, Section 8), and access to shared
    resources for all members.

-   authority of the center director

    -   to integrate cancer relevant scientists into the formal
        scientific programs of the center.

    -   for all CCSG-supported shared resources, including those located
        in partner institutions.

A comprehensive designation may be based on research in the primary
institution alone, or on supplemental strengths of the research in both
primary and partner institutions. Grants of the partner institutions may
be counted toward Program eligibility and calculation of the CCSG/NCI
funding ratio, pending a successful peer review. Specific information
must be provided in the appropriate sections of the application and
additional review criteria will be applied in the evaluation of
consortium centers (see Parts II and III).

While the terms applied to research partnerships may vary (e.g., some
centers may refer to the above arrangement as a research affiliation,
rather than a consortium), they should be clearly distinguished from
other types of arrangements, such as clinical networks or affiliations
with community hospitals designed primarily for the purpose of enhancing
clinical trial accrual or expanding the center's patient base.

**Major Research Areas and Interactions**

**Transdisciplinary and Translational Interactions between Laboratory,
Clinical and Prevention, Control, and Population Research:** A cancer
center should feature vigorous interactions across its research areas,
and facilitate collaboration between laboratory, behavioral,
epidemiologic, and clinical scientists, and the scientific Programs of
which they are a part. These collaborations should facilitate rapid
transfer of clinical observations to laboratory experiments, and
promising discoveries in the laboratory to innovative behavioral and
medical applications in prevention, detection, diagnosis, treatment, and
survivorship. In geographic areas with multiple cancer centers,
collaborations among centers may be appropriate. Centers having only
laboratory research components are encouraged to seek collaborations
with clinical units elsewhere, with industry, and with the NCI to
facilitate the translation of fundamental discoveries into tangible
patient benefit. Although no particular organizational configuration is
mandated by these guidelines, the center's organizational approach
should serve the science and be appropriate for the institution, with
reasonable breadth and depth of cancer-focused, scientific faculty and
dedicated facilities for support of the center's research areas:

# Laboratory Research: Centers should use their base of support to promote basic discovery and transdisciplinary interactions between scientists engaged in laboratory research and, where possible, to stimulate collaborations among investigators in basic laboratory and other research areas. 

# Clinical Research: A cancer center should be a major source of innovative clinical studies that can be exported, for example, to NCI's cooperative groups or directly into general medical practice. Clinical studies should involve relevant laboratory research whenever possible. In addition to fostering translation between the laboratory and clinic and conducting early proof-of-principle clinical trials, cancer centers should take leadership, as well as participate, in NCI's clinical cooperative group trials. 

-   **Prevention, Control, and Population Research**: Cancer control
    research is the conduct of basic laboratory and applied research in
    the behavioral, social, and population sciences that, either
    independently or in combination with biomedical approaches, reduces
    cancer risk, incidence, morbidity, and mortality. The scope of this
    research is extensive, including pre-intervention behavioral and
    bio-behavioral research, randomized clinical trials involving
    healthy and at-risk populations or survivors, and research focusing
    on dissemination and diffusion of effective medical and behavioral
    therapies. Prevention research is directed at healthy or
    asymptomatic populations, including those at high risk and/or those
    with detectable precancerous lesions, and cancer survivors. Not
    every cancer center will conduct research in all aspects of
    prevention, control, and population sciences. However, centers
    should demonstrate grant support not only in epidemiology, but also
    in several other areas of primary prevention, early detection,
    health services, dissemination, palliation and survivorship
    research.

**Relation of the CCSG to the Cancer Center as a Whole:** The many
functions of a cancer center in the areas of research, patient care,
education, dissemination and outreach rely on a diverse base of support
including federal, state, and local government; private industry and
foundations; third-party payers; and private philanthropy. Within this
very broad range of activities, the CCSG has a comparatively narrow
focus. The CCSG is intended to provide support for activities related to
the peer-reviewed research base of the cancer center. Although the CCSG
usually comprises a relatively small proportion of a center's operating
budget, it supports an important part of the research infrastructure,
stimulates innovation, and encourages transdisciplinary and
collaborative research. An effective clinical or comprehensive cancer
center fosters good patient care through the close association of care
and research. The effective communication of research findings between
basic, clinical, and population science venues distinguishes the
research-oriented cancer center from organizations dedicated only to
care and service. Research in cancer centers contributes directly to the
continuous advancement of services provided by the center and its close
regional affiliates and offers patients options for prevention,
diagnosis and treatment that may not be available elsewhere.

**The Relationship of Centers to Each Other:** Cancer centers, crucial
nodes in the NCI's multicenter trials programs in treatment and
prevention, relate to each other in complex ways. Cooperation among
centers is critical for the success of NCI initiatives. Centers
collaborate with each other to realize common goals outside the
sponsorship of NCI, as shown by the formation of voluntary consortia of
centers and by joint participation in collaborative studies sponsored by
private industry.

As a support mechanism for a center's research base, the CCSG is focused
on the individual cancer center; however, collaborations with scientists
in other NCI-designated Cancer Centers may be helpful for maximizing
research productivity, broadening applicability of study findings,
enhancing translation, and improving dissemination capabilities.

**Collaborations with NCI-funded Programs and Investigators:** Cancer
centers are encouraged to collaborate and coordinate their clinical
research efforts with other NCI-funded programs and investigators (e.g.,
Cooperative Groups, Specialized Programs of Research Excellence
(SPOREs), early clinical trials networks, other NCI-supported multi-site
clinical trials networks and R01 and P01 investigators. These
collaborations may include advancing research ideas from pilot studies
to phase 3 trials (with transfer between various NCI-funded programs
where appropriate), providing correlative science services for large
multi-site studies, and participating in multi-site trials conducted
through the NCI-supported clinical trials system. Meaningful
participation in these types of collaborations should be considered
positively at the time of peer review.

**Interactions with Industry:** Cancer centers may serve as important
transdisciplinary research platforms for evaluating the most promising
industry products for early detection, prevention, diagnosis and
treatment of cancer. Centers are therefore encouraged to engage with
industry in scientifically promising studies of new risk assessment
(e.g., screening, diagnostic, prognostic) tests or equipment, preventive
or therapeutic agents through clinical trials designed by center
investigators, and field-testing of new technologies important in the
discovery process. Such studies can benefit from CCSG resources if the
center plays a key role in both the intellectual and operational aspects
of the study (e.g., an investigator initiated trial with the agent
supplied by industry, etc.), findings are made available to the
biomedical research community, and the study is consistent with current
federal regulations regarding use of grant funds in projects involving
industrial partners. Meaningful participation in these types of
collaborations should be considered positively at the time of peer
review.

# Budget and Funding Policies 

**Time Limitations:** CCSG awards will generally be for periods of up to
**5** years. Award of a sixth year of funding is a joint decision
contingent upon the center's wishes and the continued stability of
center leadership and programmatic scope, as assessed by NCI program
staff after the submission of the **year 3** non-competing renewal
application.

**Some Restrictions on Allowable Budgets:** Requested and/or awarded
funds may not duplicate or replace costs normally included in the
institution's indirect cost base or various services and benefits
normally provided by the institution (e.g., purchasing services,
personnel services, and other ancillary services) in support of other
research organizations (other centers, departments, institutes, etc.).
In general, CCSG funds should not be used to compensate for NIH/NCI
administrative reductions of active research grants, cooperative
agreements, and contracts. CCSG funds may not be used to pay for
shortfalls in funded research projects due to over-expenditures on the
funded project or NIH reductions in awards. The CCSG funds are not
intended to supplement or offset any patient costs, even those directly
related to clinical research protocols, including costs for parking,
taxi fares, meals, or hotel rooms. The cost of clinical trials should be
supported by their respective funded research projects. The CCSG,
however, may support research pilot studies as allowed by the
developmental funds and protocol specific research component (See Part
II). Signatures by the principal investigator and the business official
on the face page of the CCSG application officially attest that all of
the requested costs comply with these conditions.

**Competing Continuation (Type 2) Applications - Size of Total
Request:** Applicants should contact the Cancer Centers Branch to
determine the current status of any formal budget caps and their
particular provisions. *In the absence of a formal budget cap, the
following policy applies:*

Centers have the flexibility to develop budget requests in relation to
the size of their cancer-relevant research base. The CCSG is only one of
many sources of funding available to centers for support of their
research programs.

A ratio of **0.15** between the size of the CCSG award and the size of
the NCI portion of a center\'s research base (calculated for the last
completed fiscal year) serves as an easily verifiable benchmark of the
size of a CCSG award. As funding from other NIH institutes is not
verifiable as cancer-relevant, it is not used in the benchmark
calculation. Centers with budget requests significantly exceeding a
ratio of **0.15** should provide compelling data that the cancer focus
and scientific excellence of their formal research Programs, and the
close and sustained integration of investigators from consortium
institutions, clearly justify a larger award.

**First-Time (Type 1**) **Applications -** Budget requests from a center
with no current CCSG grant should not exceed \$1,000,000 direct costs
for year one (the budget in subsequent years may receive cost-of-living
adjustments, depending on the NCI policy in effect for the fiscal year).
The NCI will consider exceptions to the general limitation on budget
requests for Type 1 applications from centers with a recent prior CCSG
award that has been phased out because of an unfundable priority score.

Budget requests exceeding the **0.15** ratio discussed above, will draw
the close scrutiny of peer reviewers; furthermore an award also can be
reduced administratively at the discretion of the NCI. The cap on the
budget request for a first-time application is largely predicated on the
limited organizational track record of a newly applying center.

**Competitive Supplemental Applications** are accepted by the NCI for
peer review and funding consideration only under exceptional
circumstances. Because supplemental applications are particularly
difficult for peer reviewers to evaluate outside the context of the
overall CCSG, they are accepted only when justification is clear and
compelling. Examples might include a fundamental change in the cancer
center's parent institution, such as a formal merger with another health
care or research institution. The applicant must clearly establish that
waiting for the next competitive renewal application cycle would have a
long-term effect on the success and/or progress of the cancer center.
Centers wishing to submit supplemental applications should make a
written request to the Cancer Centers Branch program director explaining
the exceptional circumstances. Written approval from the NCI to submit
the supplement is required and depends on the following: 1) the strength
of the arguments presented in the request; 2) the ability of the NCI to
provide peer review of the request in a timely manner; and 3) the
anticipated availability of resources to pay the request should it
receive a competitive score in peer review. Supplemental applications to
correct deficiencies noted previously in peer review will not be
accepted.

**Administrative Supplements:** Depending upon the availability of
funds, the NCI will consider administrative supplements to CCSGs to
pursue important, short-term scientific opportunities needing immediate
attention that could not be initiated and sustained through the normal,
competitive grant process (e.g., RO1s). Interested centers should
contact the program director of their grant to inquire about
availability of such funds.

**Sources of Budget Flexibility in a CCSG:** The CCSG assists
institutions by providing support for research infrastructure, such as
program leaders, center administration, shared resources and services,
and developmental funds for new initiatives. Funds for these purposes
stabilize the organization and functioning of a center, provide
centralized access to shared resources that are not attainable through
other granting mechanisms, and enhance the center's flexibility to
pursue new scientific opportunities as they arise.

CCSGs are administered under the provisions of Federal Expanded
Authorities
(<http://odoerdb2.od.nih.gov/gmac/nihgps_2001/part_iia_5.htm#_Toc.504811854>).
In accordance with the NIH Grants Policy Statement, unobligated funds of
25 per cent or less of the total amount awarded in the current year
(excluding any funds restricted by the terms of the award) can be
automatically carried over without prior NCI approval. Requests for
carryover of unobligated funds in excess of this amount will be reviewed
by NCI to ensure funds are necessary for completion of the project;
additional information, including a revised budget, may be requested
from the grantee as part of this review. If it is determined that some
or all of the unobligated funds are not necessary to complete the
project, the NCI may take one of several actions: 1) use the balance to
reduce or offset NIH funding for a subsequent budget period, 2) restrict
the grantee's authority to carry over future unobligated balances, or 3)
a combination of items 1 and 2, above. **The Financial Status Report
must specify the amount to be carried over.** **Any amount not specified
for carryover may be used as an offset for a subsequent budget period.**

Additionally, center directors have considerable flexibility to move
funds between budget areas in response to changing needs and
opportunities. The center director may increase any budget category
rated at least excellent by peer reviewers by up to 25 per cent over the
level approved by peer review without prior NCI approval. Rebudgeting of
funds into areas rated less than excellent by peer review requires prior
NCI approval, which will normally be granted if a proposed investment
would significantly improve the quality of an area important to the
center. Competing continuation applications should therefore account for
significant rebudgeting decisions with appropriate explanations and
outcome information.

**Funding Policies:** Peer review of new and competing continuation
applications over the course of a fiscal year results in a range of
priority scores for approved applications. Each year, NCI establishes a
funding policy for the Cancer Centers Program to separate applications
deserving continued funding from those that do not. Applications with
meritorious scores are funded in accordance with the NCI funding policy
in effect for the fiscal year. Applications judged not to merit funding
will receive either no funding (new applications) or phase-out funding
at negotiated levels (competing continuation applications). During the
period of phase-out, the center should be able to revise and resubmit an
amended application that addresses the concerns of peer review.

While no cap limits the size of competitive renewal increases in
individual awards, the peer review process and the NCI fiscal year
funding plan will determine the overall budget for the NCI Cancer
Centers Program. Peer review plays a major role in judging the merit of
the application and justification of budget requests. Clearly however,
many factors affect funding levels for individual cancer centers, such
as the overall availability of funds, the need to assure entry of
meritorious new centers into the program, a significant research focus
on underserved populations, and other considerations.

The ability of NCI to pay awarded CCSGs at recommended levels varies
from year to year with the size of the congressional appropriation. In
years of significant budgetary constraint, funding plans may spread the
impact over the entire program (non-competing as well as competing
grants) to reduce the adverse impact on competing centers. If funds
become available in future years, restorations may be considered.

While many cancer centers have been funded over a long period of time,
the program does undergo turnover. A center that has lost its CCSG may
reapply and recompete successfully for CCSG funding once its
deficiencies have been corrected.

######## II Submission of New & Competing Continuation Applications for a Cancer Center Support Grant

These guidelines outline the National Cancer Institute's procedures for
submission, acceptance, and review of an application for a Cancer Center
Support Grant (CCSG). CCSGs are provided through the P30 grant mechanism
to qualified applicant institutions that wish to become NCI-designated
Cancer Centers and have successfully met a series of competitive
standards associated with scientific and organizational merit.

The essential purpose of a CCSG is to foster excellent science and
productive interactions within institutions that already have a
substantial research base. The application for a CCSG should focus on
the overall excellence of the research base, the extent of the value
added to the cancer center by CCSG support, and the effectiveness of the
leadership of the cancer center. Supporting materials should be
presented in sufficient detail to convince peer review that all requests
for resources are justified.

Before an application is submitted, staff members of the Cancer Centers
Branch may assist applicants by providing advice on a range of matters
relating to the NCI Cancer Centers Program as a whole, funding policies,
and strategies for assembling a cogent and persuasive application. For
more information, call or write to:

Chief, Cancer Centers Branch

> Office of Centers, Training and Resources
>
> National Cancer Institute
>
> 6116 Executive Boulevard, Suite 700, MSC 8345
>
> Bethesda, Maryland 20892-8345 (for Express mail use Rockville, MD
> 20852)
>
> Tel: 301/496-8531
>
> Fax: 301/402-0181

# Eligibility Requirements

## Only Research Institutions in the U.S. are Eligible to Apply.

**Only One CCSG Application per Institution:** The CCSG aims to take
maximum advantage of the spectrum of resources available within a
cancer-research community. Because the major purpose of a cancer center
is to catalyze interactions among research groups from diverse
departments and disciplines, different components of an institution
should not submit separate CCSG applications. NCI encourages
applications from consortium centers, particularly those addressing the
needs of special populations or in geographic areas not currently served
by an NCI-designated Cancer Center. All consortium applications must
demonstrate integrated research (as evidenced by authorship of grants
and publications) between the partner institutions, and mechanisms for
including geographically dispersed members in programmatic activities
and ensuring appropriate access to shared resources (See Consortium
Centers, Part I).

**Funding Base**: An applicant institution must have a base of at least
\$4,000,000 in annual direct costs of peer-reviewed, cancer-related
funding. Due to the requirement for a critical mass of cancer-focused
research in formal research Programs, current NCI-designated Cancer
Centers far exceed this minimum in NCI funding alone, and new applicants
are encouraged to carefully evaluate both eligibility and potential
competitiveness prior to submission. If the cancer center is formed as a
consortium of institutions (i.e., if several different institutions are
functioning as *full participants* in the center), the funding base of
the center will be the sum of the funding bases of the individual
institutions making up the center.

## 

## Sources of Support That May Be Included for Determining Eligibility to Apply for a CCSG are:

-   **NCI Support** including the following prefixes for peer-reviewed
    grants, cooperative agreements, and contracts: R01, R03, R18, R21,
    R24, R25E, R25T, R29, R33, R35, R37, R41, R42, R43, R44, R55, P01,
    P20, P30s other than the CCSG, P50, U01, U10, U19, U54, U56, T32, K
    and F series awards and N01s (excluding SEER and other N01s funding
    materials or services).

-   **Support by Other NIH Institutes and Funding Organizations**.
    Submit non-NCI support information to determine the eligibility of
    applicants for a CCSG *only* if the applicant's NCI support is below
    the minimum. Grants and research contracts from other NIH
    institutes, and grants from the National Science Foundation (NSF),
    the American Cancer Society (ACS), and a number of other funding
    organizations can be included in the minimum if they comply with the
    NCI Referral Guidelines; an updated list of approved organizations
    is available at
    <http://cancercenters.cancer.gov/documents/fundorg.pdf>

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-   Awards from other funding organizations that utilize a peer review
    and funding system equivalent to that of the NIH may also apply
    toward the minimum; these funding sources must be approved by the
    NCI prior to application.

    **Sources of Support That May Not Be Included:** R13 grants, awards
    from commercial organizations, and NCI or NIH contracts that fund
    primarily the production of materials and/or services in support of
    research (e.g., SEER \[N01\], CIS \[N02\], and similar contracts and
    construction grants).

If the minimum funding base cannot be confirmed by a simple examination
of the NCI's grants database, the applicant should provide the following
additional information: (1) copies of existing documentation (e.g. award
statements) of NCI-supported research projects relevant to eligibility
showing the PI, grant or contract number, title, direct-cost funded
level for current year and total award period; (2) copies of existing
documentation of all non-NCI-supported research projects to be used to
reach the \$4,000,000 minimum, showing PI, funding agency,
identification number of funding agency, title, direct-cost funded level
for current year, and total award period. Also, copies of existing
descriptions of each non-NCI-supported research project should be
provided.

## Key Dates in the Grant Application, Review and Funding Process

  ----------------------- ------------- ------------- -------------------
  Pre-application         Sept-Nov      Jan-Mar       May-Jul
  Consultation                                        

  Application Receipt     January 25    May 25        September 25
  Date                                                

  Site Visit              May/Jun       Sept/Oct      Jan/Feb

  Review Committee        Jul/Aug       Nov/Dec       Mar/Apr
  Meeting                                             

  NCAB Meeting            Sept/Oct      Jan/Feb       May/June

  Earliest Start Date     Dec. 1        Apr. 1        July 1
  ----------------------- ------------- ------------- -------------------

Notify NCI staff well in advance if meeting receipt dates will pose a
difficulty. First-time (Type 1) applicants should consult with NCI staff
at least one year in advance of an application to ensure accommodation
on the review schedule. To plan for the review, the Scientific Review
Officer will request preliminary information several months prior to the
actual application receipt date.

## Pre-application Consultation (Highly Recommended)

A pre-application consultation, while not required, is highly
recommended. Pre-application consultations may be conducted via
in-person meetings between NCI staff and center leadership at the Cancer
Centers Branch offices or videoconference. Applicants who participate in
the consultation generally present applications that fare better in the
review process. The consultation, intended to help the applicant
understand the CCSG guidelines, and discuss strategies for preparing a
competitive application, should be scheduled well in advance of the due
date for submission. NCI staff will clarify the intent of the
guidelines, discuss funding trends, share generic information about
reviews of CCSG applications from similar institutional settings, and
describe the peer-review process. The applicant can define which issues
would be most helpful to discuss and then work with NCI program staff to
decide what information is most appropriate to provide. The following
are specific examples of items that help NCI staff understand the plans
of first-time applicants:

-   background and responsibilities of the cancer center director and
    the key senior leaders of the center.

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-   diagram showing the reporting, programmatic and advisory structure
    of the center; its relationship to the organizational structure of
    the institution as a whole; and a list of external advisory board
    members.

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-   how the center expects to meet the six essential organizational and
    administrative characteristics of an NCI-supported cancer research
    center.

-   formal scientific Programs and their projected leadership, and
    criteria for selecting Program members.

-   direct-cost budget estimates (in aggregate, not itemized) for the
    first year for each allowable budget category and individual shared
    resource.

-   list of active peer-reviewed research grants, cooperative agreements
    and contracts, grouped by the formal scientific Programs that will
    form the total research base of the cancer center. Typically, this
    listing is longer than the research base used to meet eligibility
    requirements. For each project, list the principal investigator,
    project title, direct-cost dollars for the current year, and the
    total project period (e.g., 5/01/02 - 4/30/07).

**Formatting Instructions for New and Competing Continuation CCSG
Applications**

These formatting instructions supplement those of the PHS Form 398
(rev.11/07). Applications fare best when the review of these complex
grant applications is as trouble-free as possible. Adherence to these
instructions will greatly assist peer reviewers in identifying sections
of the application and in matching them with the corresponding review
criteria listed below.

All pertinent information needed for evaluation should be included in
the body of the application as concisely as possible. Inclusion of
material not essential to making a center's best case for funding
dilutes the message and distracts reviewers from the major points of the
application.

**Page Limitations** apply [only]{.underline} to the narrative parts of
each section including descriptions, objectives, goals, rationale,
accomplishments, tables, figures, charts, etc. They do not include
budget pages; budget justifications; biographical sketches; publication
lists; tables on shared resource usage, clinical trial accrual, or
Protocol Review and Monitoring System activities; or lists of grants.
Page limits are maximums and are not meant to suggest the minimum or
optimum length of sections.

**Letter of Agreement to Accept the Application:** *At least six weeks
prior to the receipt date, contact NCI program staff to obtain prior
agreement to accept the application for review. All new, competing
continuation, and amended/revised applications involving budget requests
of \$500,000 or more in direct costs, must have written approval.*

The Cancer Centers Branch will notify the potential applicant by letter
or e-mail that the applicant is eligible to submit a CCSG application
and that NCI is willing to accept it for review.

*If, for any reason, the application is not submitted by the expected
date, obtain a new acceptance letter for the new planned submission
date.*

The letter of agreement to accept the application should be included as
the cover page of your submission.

1.  **Face Page**: The "principal investigator" is the cancer center
    director or designee; the "applicant institution" is the fiscally
    responsible institution of which the cancer center is a part.

2.  **Description, Performance Sites, and Key Personnel**: Provide a
    description, limited to the space provided on page 2 of the PHS Form
    398 (rev.11/07); of the CCSG-related organization and formal
    research Programs of the cancer center, and of the request for
    support through the CCSG. Provide a list of performance sites
    (including hospitals) and key personnel as per PHS Form 398 (rev.
    11/07) instructions.

**3**.**0** Include a **Table of Contents** for all major sections and
subsections of the application.

**4**.**0** Prepare a **Consolidated and Summary Budget Request** per
PHS Form 398 (rev.11/07).

**5.0 Standard Cancer Center Information**

These Summaries (see Attachment for instructions and formats) itemize
for easy reference the center's formal research Programs, shared
resources, base of funded research projects, patient information,
clinical research protocols, and a comparison of current and requested
budgets.

+-----------------------------------------------------------------------+
| Summaries 1a, b, c, and d describe the Center's senior leadership     |
| (e.g., cancer center director, deputy director, associate directors,  |
| etc.), leadership of the proposed Programs and shared resources, and  |
| cancer center membership.                                             |
|                                                                       |
| Summary 2a lists all active cancer-relevant projects competitively    |
| funded by sources external to the fiscally responsible institution of |
| which the cancer center is a part, as of the date of preparation of   |
| the summary. Grants are listed alphabetically by principal            |
| investigator in two parts\--active funded research projects, and      |
| training and career development grants.                               |
|                                                                       |
| Summary 2b summarizes the funding by category. Together with Summary  |
| 2a, it describes the size and scope of the Center's funded research   |
| base.                                                                 |
|                                                                       |
| Summary 3 provides cancer registry data regarding the numbers of      |
| patients newly diagnosed and treated at the cancer center and the     |
| number placed on therapeutic studies by cancer site. (Data in         |
| Summaries 3 and 4 may not correlate and should not be                 |
| cross-referenced.)                                                    |
|                                                                       |
| Summary 4 lists clinical research protocols open at the center during |
| a recent 12 month period, sorted by Program, category of research,    |
| sponsor, and principal investigator. (Data in Summaries 3 and 4 may   |
| not correlate and should not be cross-referenced.)                    |
|                                                                       |
| Summary 5 compares the current and requested CCSG budgets in each     |
| CCSG budget category.                                                 |
+-----------------------------------------------------------------------+

6.  **History and Description of the Cancer Center Specifically
    Describing the Six Essential Characteristics of the Cancer Center**:
    **Limit 40 pages**

**6.1 Director's Overview**

Provide reviewers with a short history and overview of the cancer
center, especially its research activities. Briefly describe the most
important research accomplishments of the center during the last period
of support and the general plans for the future scientific development
of the center. If a consortium center is being presented, clearly
outline the contributions of each institution, and the history,
objectives, and benefits of the consortium arrangement. Describe the
formal written agreements in place to ensure maximum integration and
stability across all institutions involved in the partnership. Discuss
progress in integrating research to date and facilitating access for
members to programmatic meetings and retreats and to shared resources.

**6.2 Six Essential Organizational and Administrative Characteristics of
Cancer Centers**

# Describe specifically the structure of the cancer center with respect to: 

# Facilities: Physical facilities dedicated to the conduct of cancer focused research, and to the center's shared resources, administration, and research dissemination efforts should be appropriate and adequate to the task. . Centers are clearly more successful in establishing a distinct identity if they have an identifiable physical location. All members of the cancer center need not be located physically in facilities controlled exclusively by the center, however, location of members across Program areas (basic, clinical, cancer control, and population science) in close physical proximity enhances shared use of resources and facilitates scientific interaction. Even if proximity is impossible, center shared resources should still be reasonably accessible Adequate administrative oversight of facilities providing shared resources is essential.

In your application, discuss the appropriateness and adequacy of the
facilities in relation to center identity and functions. Provide a
simple map that illustrates the geography of the center, the location of
its major activities, and the physical relationship of any consortium
institutions to the main campus. Indicate how access to shared resources
and communication are facilitated.

**Organizational Capabilities**: The center should be organized to take
maximum advantage of institutional capabilities in cancer research, to
appropriately evaluate and plan center strategies and activities, and to
promote joint initiatives, collaborations and interactions within and
among its Programs. This is a particular challenge in a large and
diverse university or when multiple institutions are included. A center
should have**:**

-   an overall programmatic structure that effectively promotes
    scientific interactions and takes maximum advantage of the
    institution's cancer research capability (this is particularly
    important to explain when the center includes multiple participating
    institutions in a consortium arrangement).

-   an efficient and cost-effective administrative organization with
    clear lines of authority.

-   the use of a standing external advisory body (appropriately balanced
    for laboratory, clinical, cancer control/population science, and
    administrative expertise) that meets at least once yearly, and
    provides objective evaluation and advice in a report to the center
    director.

-   internal advisory, decision-making, and priority setting processes
    for the conduct of center activities.

-   appropriate processes for determining and sustaining individual
    membership in the center based on productivity, research direction,
    and participation in cancer center activities.

Your application should discuss the organizational structure and
capabilities of the center. Describe how the organizational arrangements
take maximum advantage of institutional capabilities in cancer research
and promote joint initiatives, collaborations, and interactions within
and among its programmatic elements.

Describe the external advisory bodies that provide independent input to
the center director, as well as the internal governance processes for
decision-making and priority-setting, and the criteria and processes for
determining and sustaining the membership of individual investigators in
the center.

*List the non-aligned members* in alphabetical order and in a few
sentences describe their departmental affiliations, areas of expertise
and research interests. If a significant proportion of the membership
(i.e., greater than 10%) is not aligned with any of the center's
scientific Programs, describe the strategies used to take advantage of
their scientific expertise in furthering the research objectives of the
center.

Present the center's strategic planning and evaluation processes. *No
separate, formal written strategic plan is required*.

In addition, consortium centers should include a discussion of the
following:

-   how differences are resolved among consortium institutions.

-   how benefits of clinical research are made uniformly available
    across all consortium institutions.

-   how consortium institutions integrate recruitment processes to meet
    strategic goals of the center.

-   authorities of the center director over CCSG-supported shared
    resources and integration of scientists in consortium institutions.

-   access of all members to leadership opportunities within the center.

*A copy of formal written agreements documenting specifics of the
consortium arrangements and commitments should be included with the
application.*

# Transdisciplinary Collaboration and Coordination: Substantial coordination, interaction, and collaboration among center members from a variety of disciplines should enhance and add value to the productivity and quality of research in the center. These activities maximize the potential of the institution, whether small or large, to conduct transdisciplinary and translational research. An actively functioning center promotes innovative and interactive research opportunities through the formation of formal scientific research Programs, comprised of groups of investigators who share common scientific interests and goals and participate in competitively funded research and in publications. Both inter- and intra-programmatic collaboration is important.

In this section, summarize the center's major scientific strengths, its
principal research opportunities, and the transdisciplinary coordination
and collaboration between cancer center members, including intra-and
inter-programmatic collaborations and those involving consortium
institutions. Discuss how productivity and quality of translational
research in the center is enhanced by these collaborations. Describe
ways in which the center promotes creative, innovative, high-quality,
and interactive research opportunities.

**Cancer Focus:** A defined scientific focus on cancer research should
be clear from the center members' grants and contracts, by the structure
and objectives of its formal Programs, and the collaborations between
laboratory researchers and others who are more directly concerned with
application of research knowledge. While the definition of cancer
research is not infinite, NCI recognizes that many aspects of cancer
research are resistant to neat labels and that cancer-relatedness should
be a matter of flexible interpretation.

In this section, discuss how the center's grants and contracts, its
programmatic structure and objectives, and the collaborations between
laboratory, clinical and public health scientists reflect a clearly
defined scientific cancer focus. Describe the most important discoveries
occurring in the center during the last period of support to help
reviewers understand what the center's investigators consider their most
important achievements.

# Institutional Commitment: The center should be recognized as a formal organizational component with sufficient space, positions, and discretionary resources to insure organizational stability and fulfill the center's objectives. The CCSG makes a major financial contribution to an institution's research infra-structure. The NCI designation lends stature to an institution by attracting patients, industry research support, and philanthropy. The NCI substantially invests in cancer centers and expects similar commitment of the institution(s) to the center. Commitments of parent institutions to the cancer center frequently include the following: 

-   Recognition of the cancer center as a formal organizational
    component with a distinct identity.

-   Provision of research, clinical, and administrative space and
    positions.

-   Provision of central discretionary funds (e.g., philanthropic funds,
    indirect cost return, clinical revenues) under the control of the
    director for the center.

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-   Formal codification in institutional policy of:

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-   the organizational status of the cancer center and authority of the
    center director as comparable or superior to that of departments and
    department chairs.

-   reporting structures.

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-   responsibility of other institutional leaders (deans, hospital
    presidents, and department chairs) to ensure cross departmental
    integration and long-term stability of the center, and to support
    cancer center objectives, including access to clinical inpatient and
    outpatient facilities and joint oversight of faculty critical to
    linking oncology care and research.

-   a well-defined plan for a change in directorship and for
    institutional commitment to continuing support of the cancer center.

This section of your application should describe the institutional
commitment to the center, including its recognition and status as a
formal organizational component; the provision of space, positions and
discretionary resources; the authorities of the director; the status of
the director in comparison to departmental chairs; reporting structures;
responsibilities of institutional leaders to ensure the long-term
stability of the center; and a plan for assuring continued commitment of
the center in the event of a change in directorship.

*Include a letter signed by the Dean and Hospital President or other
appropriate institutional officials documenting specifics of
institutional commitment both for the long term future of the center and
for this award period.*

The stability of a consortium should be demonstrated via provisions of
formal written agreements, as well as the history of collaborative
research activity, and the contribution of each consortium institution
to the cancer center. A copy of this agreement should be included with
the application.

**Center Director:** The director should be a highly qualified scientist
and administrator with leadership experience and institutional authority
appropriate to manage the center, whether it is a small institution or a
highly complex consortium. The director should serve the center on a
full-time or a significant part-time basis, and should have the
following authorities:

-   A senior position (within a matrix center, at least equivalent to a
    Departmental chair), with appointments to decision making committees
    relevant to the cancer center and formally codified authorities.

-   Control of faculty appointments to the cancer center, and of their
    periodic review for continued membership (i.e. ultimate authority
    for determining which individuals will be productive, contributing
    members of the cancer center).

-   At a minimum, joint control (for example, with a department
    chairman) of recruitments of individuals who are to be members of
    the cancer center.

-   Full or shared control of specific research and resource space and
    equipment dedicated to the cancer center; this control provides the
    independent flexibility to enhance and develop the research
    capability and resource needs of the center.

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-   If conducting clinical research, sufficient authority of the center
    director or designee over inpatient and outpatient facilities to
    achieve center clinical research objectives, and over the
    appointment and performance of individuals critical to linking
    oncology care to clinical research.

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-   Control of philanthropic funds donated to the cancer center.

In your application, describe the qualifications of the center director
in relation to scientific background and leadership experience and
his/her time commitment to the center. Describe the status of the center
director within the institution; any appointments to decision-making
committees relevant to the cancer center; and authorities in relation to
integration of research across schools and departments, appointment and
review of Program members, recruitments and faculty positions, research
and resource space and equipment dedicated to the center, revenue
streams, and inpatient and outpatient facilities.

Consortium centers should include a discussion of the authorities of the
center director over CCSG-supported resources in collaborating
institutions and the integration of scientists from consortium
institutions into the formal scientific Programs of the center.

**7.0 Descriptions, Budgets, and Narrative Justifications for Individual
CCSG Components**

# Using the forms and instructions in the PHS Form 398 (rev.11/07), for [each]{.underline} allowable budget category for which funds are requested, prepare:

# a description

# a budget for the *First 12 month Budget Period* 

# a summary budget for the *Entire Proposed Project Period.*. 

# Do not provide narrative justifications for individual Program leaders, since this information is already included in the *Research Programs* section of the application. Include a simple consolidated budget for Program leaders. 

The CCSG is intended to provide reasonable costs for a great variety of
activities that are clearly related to the research needs of the cancer
center. The narrative describing the role and function of requested
personnel should clearly justify the stated percent effort, whether or
not salary is requested. The major categories of allowable costs include
the following:

**7.1 Senior Leadership: No more than 1 page per senior leader.**
Prepare a description and a consolidated budget of percent efforts for
all senior leaders and narrative justifications that carefully describe
their roles. Each narrative should be followed by a biographical sketch
(see PHS Form 398 rev. 11/07).

Individuals in pivotal leadership positions in the center are eligible
for salary support for the time and effort they devote to its research
activities. They should be in place and committed to a defined percent
effort commensurate with duties and responsibilities. Applicants and
reviewers should consider the breadth and complexity of the role of each
senior leader and determine the appropriate level of effort needed to
meet this responsibility. Requests should not be based on any perception
that reviewers expect a standard level of effort for all senior leaders.

**7.2 Leaders of Scientific Research Programs: Budget pages only.**
Provide only a single consolidated budget that lists all Program leaders
in the center and their percent efforts. This is merely a consolidation
of the separate budgets provided and justified in 7.0. Do NOT provide
any narratives.

**7.3 Staff Investigators: No more than 1 page per Staff Investigator.**
The P30 Cancer Center Support Grant Guidelines state that members of the
center who are clearly important contributors to the programmatic or
translational activities of the center may receive salary from the Staff
Investigator budget for their specific roles in the center. ***To
qualify individuals should either play a definable and special role in
helping the center achieve scientific objectives above and beyond their
own research (Research Staff Investigator) or an important role in the
clinical activities (Clinical Staff Investigator) of the center*.**

Research Staff Investigators must be a Principal or Co-Investigator on
at least one NCI approved peer-reviewed and funded research-project
award. Peer review of Research Staff Investigator candidates includes
their research track record, their special importance to the center, and
whether their budget allocation is commensurate with the time and effort
for activities not supported by other awards.

For Clinical Staff Investigators, peer review criteria include their
contributions to development and implementation of the center's clinical
activity, including authorship of clinical trials, accrual of patients
on interventional trials, or leadership roles in cooperative group
studies, and whether their budget allocation is commensurate with the
time and effort devoted to these activities.

The Guidelines do not prohibit members with other official roles in the
Center from receiving additional support as a Staff Investigator,
however, responsibilities for each role should be clearly distinguished.
The duties associated with that of a Program Leader, for example,
include fostering transdisciplinary, inter- and intra-programmatic
interactions relevant to programmatic research goals. Effective Program
Leaders provide stimulation, focus, and direction which enhance
individual productivity of scientists and result in productive
collaborations within and between programs. An additional role as Staff
Investigator for a Program Leader should be distinct and clearly
justified by separate functions.

Prepare an overall description for the component, and a consolidated
budget. While there is no limit to the number of Staff Investigators
that may be requested, choices should be made judiciously and clearly
justified by the description of duties. Provide a separate narrative
justification, with a detailed description of duties, and a biographical
sketch for each Staff Investigator. The narrative should specify the
category of Staff Investigator, the formal research Program(s) of the
Center in which the Staff Investigator participates, and other
information pertinent to the request (e.g., for Research Staff
Investigators, a list of peer reviewed grants on which they serve as
Principal or Co-Investigator; for Clinical Staff Investigators, a list
of authored trials, etc).

**7.4 Planning and Evaluation: No more than 5 pages.** Provide an
overall description, a consolidated budget, and a narrative
justification for each planning and evaluation activity. The narrative
should summarize how past CCSG funds were used, what was accomplished to
improve and develop the cancer center, and how future needs will be met
with the requested budget. While budgetary support for development of
future scientific Programs is not allowable in the CCSG,
[plans]{.underline} for developing such Programs should be included in
this section. Include a consolidated list of the individuals comprising
the External Advisory Board, with titles and institutional affiliations,
and attach their biographical sketches. Discuss recommendations made by
the external advisory group, any actions taken in response to those
recommendations, or reasons for not responding. Present the center's
planning and evaluation processes, in this and other relevant sections
of the application. No separate, written strategic plan is required.

## Costs of planning and evaluation might, for example, include support for a well-qualified external advisory committee; the use of ad hoc scientific and technical consultants when appropriate; a seminar series, when the speakers or invited participants clearly serve as consultants for the Center's scientific or administrative activities, as documented by agendas and/or written evaluations; retreats designed to stimulate transdisciplinary research opportunities; and the conduct of regular assessments of research progress, interactions, membership participation, etc. by the senior leadership of the center. Use of Developmental Funds (see below) should be guided by the priorities and opportunities identified through the planning and evaluation activities of the center.

**7.5 Developmental Funds: No more than 15 pages.** Prepare an overall
description and a composite budget that includes all developmental fund
categories being requested and explain how they will be linked to the
strategic and programmatic priorities and scientific opportunities of
the center. Also provide individual budgets by category with separate
narrative justifications. Narratives should summarize how past CCSG
developmental funds were used, what was accomplished with them (e.g.,
establishment of a new shared resource, number of recruitments and areas
of expertise, number of pilot projects resulting in peer-reviewed
funding, etc) and how the new request will be used to meet the centers
strategic goals. If pilot projects are proposed, describe how the
projects are reviewed for scientific merit and selected for funding.

## Developmental Funds are the major source of budgetary flexibility in the CCSG and should be linked substantially to the planning and evaluation activities of the center. These funds allow centers to take risks; strengthen weaker scientific areas; and provide scientists the opportunity to explore innovative ideas, new collaborations and new technologies. This request category has no dollar limit or limit on the percent of the total CCSG budget. 

The cancer center must centrally monitor and evaluate the effectiveness
of all developmental funds. These funds can be administered
flexibly\--dispensed centrally by the director and senior leaders to
achieve broad strategic objectives or be delegated to individual Program
leaders to target specific scientific objectives. The latter approach
has proven to be very successful for many cancer centers.

Maintain careful records on allocation of developmental funds, the
rationale for their use, and their effectiveness. Developmental funds
may not pay for training, routine equipment purchases or upgrades for
established shared resources, or salary support for Program leaders.
They should not be used to cover costs associated with the recruitment
process itself or for large equipment purchases associated with
recruitment packages.

## Developmental funds may be used only for the following: 

## To recruit faculty level scientists in areas of strategic need: Judicious recruitments strengthen weak areas of science and enhance the center's overall research strength. Eligible investigators therefore are: (1) those newly recruited from outside the parent institution, with developmental support beginning at the time of, or very soon after, arrival at the grantee institution. (2) those [inside]{.underline} the institution who, whether junior scientists or well established in other scientific areas, are entering the field of cancer research as independent investigators for the first time. 

> Developmental funds may not be used to support training or tuition
> costs, but may fund recruitment packages that include the staff needed
> (e.g., technicians, graduate students, postdoctoral fellows) to
> initiate the research program of a new investigator. The duration of
> support from these funds should not exceed 3 years. This category
> should provide temporary support permitting a new cancer investigator
> to establish his/her scientific activities at the new center and
> achieve independent funding. Developmental funds cannot support
> established cancer researchers already within the institution (e.g.,
> principal investigators on NCI supported R01s or subproject leaders on
> P01 or P50 multicomponent grants).
>
> In your application, explain how these developmental funds were used
> in the previous 3 to 5 year grant period, specifying which
> investigators and projects were supported, the rationale for
> recruiting these investigators relative to the needs of the center,
> and to what extent these investigators were subsequently productive as
> evidenced by research grants and publications.
>
> Identify the kinds of individuals the center plans to recruit as part
> of its future plans for developing the center. Identification of
> particular individuals or research plans is not necessary.

## Interim salary and research support: The center director may provide partial support for up to 18 months to an investigator who has a reasonable probability of regaining independent research support in the near future. Interim salary and support is independent of any salary funded by the CCSG in the Staff Investigator category. Individuals who are having chronic difficulty with peer-reviewed grant support, and for whom permanent institutional funds are not available, are ineligible. 

## Your application should include a description of the process and the criteria used to select investigators for interim support. The use of interim salary and research support must be reported to NCI in each non-competing continuation application. Peer review at the next competitive evaluation will examine the uses of the interim support category and the success that individuals supported from this category have had in regaining peer-reviewed grant support. 

## To support pilot projects that allow center scientists to pursue new, innovative, high-risk ideas or stimulate high priority research areas (e.g., translational research): Centers are encouraged to make these funds accessible to all applicable areas of research, including laboratory, clinical, prevention, control, behavioral and population research for projects of relatively short duration (i.e., 1-2 years). Pilot projects may be awarded to either new or established investigators. Developmental funding may be used for pilot projects or feasibility studies preparatory to the development of an application for independent peer-reviewed support, or to take maximum advantage of a unique research opportunity or nurture an innovative idea. Funds may stimulate a high priority research area, explore a new direction for a Program, explore an unconventional hypothesis, or encourage cross-disciplinary translational research. Support of small, hypothesis-driven early clinical trials of an exploratory nature is particularly encouraged.

> Your application should describe the processes for eliciting
> high-quality proposals and review of scientific merit, and list the
> awardees and their projects for the preceding project period. Describe
> the outcome of all projects supported by the CCSG through the
> pilot-project mechanism (e.g., grant awards, publications, etc.).

## To support technology/methodology development projects: NCI encourages the development of new technologies that will advance cancer research. In these Guidelines, technology refers broadly to methodologies (procedures, instrumentation, analytical tools or reagents) that address important problems in cancer research, including, but not limited to, areas such as the detection and analysis of molecular signatures of cancer in vitro or in vivo, biomedical imaging, model development, drug discovery, tumor targeting, drug delivery, survey development, and informatics.

> Funds for technology development projects can be awarded through an
> internal review process to resource leaders and individual cancer
> center scientists. Review criteria should emphasize scientific merit,
> innovation, and the likely impact of success on important areas of
> cancer research. If CCSG resources are used in partnership with
> industrial resources, the cancer center must assure that applicable
> federal law governs the public availability of any final products of
> the research.

-   **Development of new shared resources and novel components in
    existing shared resources***:* Developmental funds may be used to
    help develop new shared resources or new and unique components in
    existing shared resources whenever the center recognizes the need.
    If the resources are sufficiently developed to be proposed and
    reviewed as established resources, they should be proposed under the
    shared resources category. New [and]{.underline} unique components
    for existing shared resources may also be supported, but must be
    fully justified.

**7.6 Cancer Center Administration: No more than 10 pages.** Provide a
description, budget and narrative justification. Limit the
administrative budget request and narrative justification to the
specialized research needs of the center. Include the costs necessary
for central administration of resources and services required for center
research activities, fiscal management of the center, and reporting
activities. Because administrative structures differ from center to
center, carefully explain and justify requested support.

## The CCSG central administrative budget may support an appropriate percentage of the salary of the chief administrator, secretarial and other staff, travel needs of senior leaders and Program leaders in the performance of their center-specific roles, and supplies for the administrative functions of the center. Funding for a percentage of salary for a staff person to support links with state health departments, other state agencies, or the Centers for Disease Control and Prevention (CDC) is allowable, as well. 

## Examples of non-allowable costs include non-research educational activities, public relations, fund-raising, and grant application and manuscript preparation. Matrix centers should not duplicate parent institution responsibilities i.e. services normally supported through indirect costs or functions and services the institution normally provides to other comparable research units of the institution (e.g., departments). 

**Describe the:**

-   Role of individual administrative staff and their specific
    responsibilities, including staffing and other support for the
    administrative office provided by the CCSG and other funding sources

-   Funds committed to the center by the institution, including amount,
    source (e.g., separate return of indirect costs, endowment income,
    clinical income, or other support), and use (including processes for
    determining how funds will be used).

-   Role of the center within the institution, including relationships
    with the central grants office of the parent institution (e.g.,
    level of support and overlap of functions) and with clinical
    entities (e.g., in-patient, out-patient, and networks), and other
    pertinent entities.

-   Decision making processes at the center and the role of
    administration.

-   Policies regarding

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-   Use of cancer center space.

-   Grant submission procedures and the subsequent effect on budgeting
    and indirect cost return

-   Shared resources, including center oversight, prioritization
    process, prices, chargebacks, subsidies or differential charges,
    auditing, user satisfaction measures, and quality control.

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-   Administration's role in support of

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-   Faculty recruitment processes, including cooperative efforts with
    academic departments in recruiting faculty, funding salaries, and
    conducting tenure reviews.

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-   Space management, including policies on assignment and retention.

-   Membership application processes, including policies on appointment
    and removal.

-   Arranging and documenting meetings organized by the center.

-   Management of philanthropic funds.

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-   Processes for solicitation, receipt, review, award, and monitoring
    of pilot projects

-   Budgeting processes and responsibilities for accounting and
    expenditure monitoring.

-   Purchasing processes.

8.  **Research Programs**

**8.1 Goals:** Cancer centers foster cancer-focused research, in part
through the creation of formal scientific Programs. A Program comprises
the activities of a group of investigators who share common scientific
interests and goals and participate in competitively funded research.
Programs should be highly interactive and lead to exchange of
information, experimental techniques, and ideas that enhance the
individual productivity of scientists and often result in collaborations
and joint publications. Ultimately, the success of Programs is measured
by scientific excellence and the emergence of productive collaborations.
How this is achieved will vary with the center and the needs of
particular Programs. Formal or informal planning meetings, seminars and
retreats, developmental funding of selected pilot projects, new shared
resources or key recruitments may be effective ways of promoting
increasing levels of interaction.

**8.2** S**election of members** of a center's Programs is one of the
most critical decisions made by leadership. Functional and productive
Programs select individuals for their scientific excellence and, just as
importantly, for their commitment to work together to further the
scientific goals of the cancer center. Program members may contribute in
any of the four missions of the cancer center - research, education,
dissemination, and clinical investigations. Some Program members may not
necessarily hold peer-reviewed grants, but may contribute to the
research objectives of the center in other important ways and their
contributions should be recognized. ***Clinical investigators may be
eligible for CCSG funding as Clinical Staff Investigators.***

Many Programs in cancer centers involve sustained collaborations with
scientists who clearly strengthen and enhance value-added interactions
and the scientific productivity of the research but who have no formal
appointment within the institutions that comprise the cancer center.
Collaborators from other NCI- designated Cancer Centers or research
institutions may become center and Program members. While the funded
research projects of these members cannot count toward the funding base
of the Program, these members may have full access to shared resources
and developmental funds.

**8.3 Characteristics of Programs:** Programs should be of adequate size
and scientific quality, should exhibit a high degree of interaction, and
should be capably led. A Program must have at least 3 peer-reviewed and
funded research projects (e.g., % R01~1~ + % R01~2~ + % R01~3~ = 300%)
from a minimum of 3 separate, independent principal investigators.
Peer-reviewed, funded research sub-projects of larger grants (e.g.,
P01s, P50s) may be counted as separate projects, but not cores.

The interactive attributes of a Program are documented most convincingly
by collaborative research projects and joint publications. Colloquia,
joint seminar series, and other evidence of meaningful interchange serve
to cement interactions around related or common goals. In addition,
effective leadership provides intellectual stimulation, cohesion, focus,
and direction.

**8.4 Definition of Peer-Reviewed, Funded Research Projects for
Inclusion in Programs and for Designation of Users in Cores:** Peer
review as employed by the NIH is the acceptable standard for inclusion
of a cancer-related research project within a formal Program.
Peer-reviewed, funded projects include the following:

-   Awarded individual research grants, cooperative agreements and
    research contracts from the NCI including all awards with the
    following prefixes: R01, R03, R18, R21, R24, R25E, R29, R33, R35,
    R37, R41, R42, R43, R44, R55, P01 and P50 sub-projects, P30s other
    than the CCSG, U01, U54, U56, N01 *research* contracts and
    peer-reviewed, funded subcontracts of center members participating
    in collaborative research. (Note: Shared resources/cores of
    multi-component grants are not eligible for inclusion.)

-   Components of National Cooperative Groups (e.g., U10s, U19s) funded
    by the NCI

-   Individual research studies involving protocols approved by the NCI
    Cancer Therapy Evaluation Program (CTEP) and funded by NCI.

-   Individual research studies involving prevention and control
    protocols approved by the NCI Cancer Control Protocol Review
    Committee and funded by NCI.

-   Awarded research grants, cooperative agreements, and research
    contracts from other institutes of the NIH (same prefixes as above).

**Awarded *research* grants from the following organizations also meet
the NIH peer review standard**:

  ----------------------------------- -----------------------------------
  Agency for Health Care Research and American Foundation for AIDS
  Quality (AHRQ)                      Research (AFAR)

  American Cancer Society (ACS):      American Institute for Cancer
  national office only                Research (AICR)

  Prevent Cancer Foundation           Centers for Disease Control and
                                      Prevention (CDC)

  Central Office of the Veterans      Environmental Protection Agency
  Administration (VA) - excluding     (EPA)
  local/regional awards and "block"   
  grants                              

  Food and Drug Administration (FDA)  Howard Hughes Foundation

  Leukemia and Lymphoma Society       Multiple Myeloma Research
                                      Foundation

  National Institute for Occupational National Science Foundation (NSF)
  Safety & Health                     

  Susan G. Komen for the Cure         U.S. Army (DOD) special research
                                      programs in ovarian, breast &
                                      prostate cancer

  University of California-Wide       Florida Biomedical Research Program
  Breast Cancer Research Programs     
  ----------------------------------- -----------------------------------

If a center has individual funding from an agency not listed above, they
may request that the agency receive peer review consideration. It is
inappropriate to predicate programmatic eligibility or scientific
breadth and depth on funding of this nature, however. Instructions and
application forms for requesting peer review consideration of selected
individual cancer research grants from a source not listed above may be
found at http://cancercenters.cancer.gov/documents/fundorg.pdf.

Submit 5 copies of the form to the address below *by the time of CCSG
application*:

Referral Officer

> National Cancer Institute
>
> 6116 Executive Boulevard, Room 8041, MSC 8329
>
> Bethesda, Maryland 20892-8329 (for Express mail use Rockville, MD
> 20852)
>
> Tel: 301/496-3428
>
> Fax: 301/402-0275

**8.5 Formatting For Each Program Section:** **Limit of 25 pages per
Program on average**, excluding title page, biosketches, budget, budget
justification, and lists of funded projects, clinical trials, and
publications. Centers that include most or all clinical research in one
Program may exceed the page limitation for this Program only.

-   **Title page** of the Program with the name(s) of the Program
    leader(s) and the Program code (used in Summaries 1 and 2 of the
    Standard Cancer Center Information Summaries).

-   A description of the Program using page 2 of the PHS Form 398 (rev.
    11/07), including:

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-   the central themes and scientific goals of the Program.

-   the number of Program members and the number of departments and
    schools represented.

-   the NCI and other peer reviewed cancer-relevant support for the last
    budget year.

-   the total number of publications and the percentage of
    intra-programmatic and inter-programmatic publications in the last
    grant period.

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-   A **budget** for the percent effort of the first and future years
    for the Program leader(s) using the standard budget pages provided
    in the PHS Form 398 (rev. 11/07). A level of effort must be included
    for each Program leader whether or not salary is requested. Indicate
    if salaries meet or exceed the NIH salary cap.

-   A **budget narrative justification** based on the specific role of
    the Program leader(s) in facilitating the discovery process and
    promoting transdisciplinary research important to cancer.

-   **Biographical sketches** of Program leaders(s) Use the PHS Form 398
    (rev. 11/07). Note that the form includes information on positions
    and honors, selected peer-reviewed publications, and research
    support. Information on other support beyond that required in the
    biosketch should NOT be submitted with the application.

-   A list of the **externally funded research projects** of the Program
    separated into two categories: **"peer-reviewed"** and **"non peer
    reviewed"** by member, project and funding source, using the format
    described for Summary 2A. **Program leaders should exclude grants
    focusing on other diseases (e.g., diabetes, cardiology, Alzheimer's
    disease) or address their cancer relevance in the programmatic
    descriptio**n \-- particularly for Program members whose
    peer-reviewed funding includes **only** grants in other diseases.

-   If applicable, a list of the **clinical research** of the Program,
    using the definitions and sort order specified in the instructions
    for Summary 4.

-   The **members** of the Program in alphabetical order, with their
    departmental and institutional affiliation, their academic rank (or
    equivalent) and their role in the Program (e.g. researcher,
    clinician placing patients on clinical trials). Highlight any
    members of the Program who are proposed as Staff Investigators by
    indicating for each person the percent effort for which CCSG salary
    support is being requested.

-   The **scientific goals** of the Program and how the interests,
    expertise, and research approaches of the Program members facilitate
    their achievement.

-   The most significant **scientific accomplishments** of the Program
    within the last 5-year project period and the ways in which the
    cancer center facilitated or enabled these accomplishments.

-   For clinical and translational Programs, describe accrual of
    patients to all types of clinical trials, in relation to the patient
    population, using the format described for the Clinical Protocol and
    Data Management Shared Resource (see Section 9.1). A total of 10%
    accrual to therapeutic and prevention trials constitutes a general
    benchmark for a reasonable level of protocol accrual. Briefly
    describe activities that demonstrate leadership, interaction, and
    collaboration in other NCI-funded clinical programs, such as
    Cooperative Groups and SPOREs, and in other multi-site clinical
    networks.

-   Interactiveness of the Program members with each other and with
    members of other Programs, as documented by Program agendas (minutes
    not required) and other activities.

-   The number of total publications of the Program and the percent that
    are inter- and intra-programmatic. Report this information in the
    Program description. Of total publications, 10% inter- and 10%
    intra-programmatic publications constitute general benchmarks for a
    reasonably interactive Program. Publications should represent the
    broad diversity of Program members.

-   A ***selected*** list of Program-related publications from the last
    project period. Indicate those that particularly illustrate the
    inter- and intra-programmatic collaborations.

**9.0 Shared Resources and Other Support Elements:** **No more than 15
pages per resource**, excluding usage tables

The CCSG may pay for fixed costs associated with centralized shared
resources and services. These costs are not directly identified with
specific research grants. (With the exception of Protocol Specific
Research Support and Developmental Funds for pilot projects, CCSG funds
do not support project-specific research activities, which are paid for
by research project grants.)

## NCI recognizes that virtually all shared resources derive a portion of their operating costs from multiple sources. These guidelines therefore apply only to the proportion of the shared resource that is paid for by the CCSG.

**9.1 Shared Resources** provide access to technologies, services, and
scientific consultation that enhance scientific interaction and
productivity. The support of shared services for an entire center
provides stability, reliability, cost-effectiveness, access to
specialized technology and methodology, and quality control.

## The primary users of shared resources and services are cancer center members with peer-reviewed, funded projects, a standard assuring CCSG funds support high-quality research. Access by others is at the discretion of the center director and should be justified by contributions to the overall cancer research objectives of the center (e.g., access by a junior investigator funded by a pilot project). 

Although demand and level of usage are important in evaluating requests
for CCSG support of shared resources, certain technically sophisticated
resources are critical to a center's research progress (e.g., x-ray
crystallography, preparation of clinical grade gene therapy vectors,
proteomics, family ascertainment, health communication, tracking,
nutrition support) but are not adaptable to high-volume operation or
will have a few very specialized users. Such resources are judged for
scientific value, the needs of past and potential new users,
accessibility to cancer center members, and the effectiveness and
fairness of the process for setting scientific priorities for their use.
Shared resources should never be established for exclusive or primary
use by one or two members only, however.

**Support Resources Not Typically Supported by Chargebacks to Research
Grant Mechanisms:** Some types of shared resources, such as
biostatistics, informatics, and clinical protocol and data management,
provide crucial services that are not typically supported by chargebacks
to research grant mechanisms. Usage criteria by funded investigators are
not applicable to these shared resources. Clinical trials cores
certainly accept patient registrations onto clinical trials by
non-funded cancer center members. Biostatistics reviews all clinical
trials and collaborates in developing new grant applications by as yet
unfunded investigators.

**Possible Shared Resources:** A center proposes those functions that it
wishes to have funded as shared resources, but then must defend its
choices and the associated budget request at peer review. A center is
not limited to the list of examples of potential shared resources below
supporting laboratory, clinical, and prevention/control/population
sciences:

-   centralized equipment; general and specialized animal colonies;
    specialized instrument shops; nucleic acid sequencing/synthesis
    labs; amino acid analysis HPLC facilities; cell sorting; chemical
    and drug synthesis labs; mass spectrometry labs; electron microscope
    facilities; media preparation; microarrays and proteomics facilities
    and services.

-   histology and pathology services; tissue culture; tumor procurement
    service; immunology or immunoparameters testing facilities;
    radioisotope facilities; experimental radiation facilities and
    services; clinical data management and protocol tracking for
    clinical trials.

-   biostatistics; imaging; clinical and population science economic
    analysis units; research-related informatics; other biospecimen
    (e.g., serum) procurement services; clinical and population science
    measurement units; survey research facilities; intervention,
    recruitment or dissemination shared resources; high-risk family
    registries.

Centers present resource requests in various ways. Some prefer to group
several shared resource components into a single categorical request
(e.g., Immunology, Cell Biology).

**Budgets:** In general, the CCSG provides salary stability for some of
the "fixed" costs associated with key personnel operating the resource
and providing consultative services, as well as minimal supplies;
"variable" costs are usually supported by user fees or by other sources.
Costs will depend upon the frequency of use of the resource, as some
resources will be more self-sustaining than others and will cost the
CCSG less, and also upon whether the service is a support function
(e.g., glass washing, media preparation), or whether it provides access
to expertise and technology (e.g., DNA sequencing, transgenic mice), or
to collaboration (e.g., biostatistics).

## Operational Costs to the CCSG: Because special considerations depend upon the characteristics of the institution (the technical or non-technical nature of the resource, and the proportion of the resource paid for by sources other than the CCSG), no standard approach applies to all shared resources and services. Since the primary costs of research are supported by the peer-reviewed, funded grants and research contracts of the center, consider the following elements in developing budgets for shared resources and services: 

## need for the resource relative to current and future peer-reviewed research activities of the center. 

## current and projected use of the resource by multiple investigators. 

## cost-efficiency, particularly in comparison to other options (e.g., purchase orders or contracts to an outside vendor).

## stability of the operation and quality of the service. 

## accessibility of the resource or service to qualified member-investigators, including the critical consultative role performed by experts who direct selected shared resources.

## proportion of the total resource operation paid for by the CCSG relative to other sources. 

**National Institutes of Health (NIH) Policy Relative to Program
Income:** As with all other grants issued by the NIH, if income is
realized from grant-supported activities (e.g., from CCSG supported
shared resources), this income must be reported in the budget/financial
statements accompanying annual progress reports and on the annual
financial status report. In accordance with NIH Grants Policy, the
"additive cost alternative" will apply to the first \$25,000 of program
income. Unless approved for use otherwise, program income in excess of
\$25,000 will be deducted from the next year's award.

**Formatting:** The 15-page limitation, excluding capacity and usage
tables, is intended to accommodate bundled requests of this kind.
Requests for most individual shared resources should require much less
than the 15-page limit.

-   Prepare appropriate description, budget information, data and
    narrative justifications for each resource.

## For institutionally managed (as opposed to cancer center managed) resources, describe the center role in setting priorities, resource planning and oversight, as well as priority access established for center members. 

-   Present all shared resources critical to the clinical research needs
    of the center (e.g., biostatistics, centralized protocol management
    office) last, so they can be reviewed in sequence with the next
    sections, "Protocol Review and Monitoring System",
    "Protocol-specific Research Support.", "Data and Safety Monitoring",
    and Data Sharing.

In the narrative for each shared resource, describe the:

-   services and technologies provided and their importance in relation
    to the scientific needs and objectives of the cancer center.

-   qualifications of the resource director(s) and the competence of key
    technical staff; include a biosketch of the resource director(s) and
    manager(s).

-   center's policies on operation and use of the shared resource, e.g.,
    access, priorities, limits (e.g., hours of operation, staffing,
    etc.), and charge back systems.

-   cost-effectiveness of the resource relative to other options for
    obtaining the service, such as outside vendors, when applicable, and
    the approach used to evaluate the current extent of use by
    peer-reviewed, funded center investigators, and projected increase
    in use, if applicable, based on the scientific needs of the center.

**Record keeping:** Maintain user logs for each shared resource and
service and have them available at the site visit.

**Shared Resource Data Format:** Provide the following data in the
application:

Current grant year reporting period: Choose one

\_\_\_\_\_ January 1 to December 31: 20??

\_\_\_\_\_ July 1 to June 30: 20??-??

\_\_\_\_\_ Grant year: provide inclusive dates

This shared resource is:

\_\_\_\_\_ cancer center-managed

\_\_\_\_\_ institutionally-managed

\_\_\_\_\_ jointly managed

\_\_\_\_\_ other (Explain)

## Total Operating Budget: The requested budget should reflect realistic needs in terms of availability of support from other sources (e.g., institutional support or recovery from chargeback); recent past utilization by the scientists accessing the resource, anticipated future increases in usage, and any other specific additional requirements. Provide the following information for the most current grant year and for the proposed period of support. 

+------------------+----------+---------+----------------+-----------+
| Income Source    | Current  | Percent | Proposed       | Percent   |
|                  |          | of      |                | of        |
|                  | Support  |         | Support - Year | Proposed  |
|                  | (\$)     | Current | 1 (\$)         | Total     |
|                  |          | Total   |                | Budget    |
|                  |          | Budget  |                |           |
+------------------+----------+---------+----------------+-----------+
| CCSG             |          |         |                |           |
+------------------+----------+---------+----------------+-----------+
| Other            |          |         |                |           |
+------------------+----------+---------+----------------+-----------+
| Charge backs     |          |         |                |           |
+------------------+----------+---------+----------------+-----------+
| Institutional    |          |         |                |           |
| support          |          |         |                |           |
+------------------+----------+---------+----------------+-----------+
| Other sources    |          |         |                |           |
+------------------+----------+---------+----------------+-----------+
| Total Operating  |          |         |                |           |
| Budget           |          |         |                |           |
+------------------+----------+---------+----------------+-----------+

**Capacity of Resource:** List the major services provided by the shared
resource, indicating and defining an appropriate unit of measure (number
of samples, hours of technical or professional times, etc.) for each
**major** service provided (e.g., number of nucleotides sequenced, \# of
samples processed, etc.); services can be clustered, where appropriate.
For each service indicate the total capacity per year based on your
current equipment, staffing, space, and available work hours. Do **not**
include this table for the support resources described above.

  ------------------- ----------- --------------------------- ------------
  Name of Service     Unit of     Definition of Unit of       Total
                      Measure     Measure                     Capacity
                                                              /reporting
                                                              12 month
                                                              period

  DNA sequencing      \# of       Number of samples,          
                      samples     sequences, etc.             

                                                              
  ------------------- ----------- --------------------------- ------------

# Shared Resource Use: For each service listed in the table above, provide the total number of users in each category, the total units used for investigators in each category, and the percent of the total resource capacity that is used by each category of investigators. For the top 75% of units of use during the reporting period, list the individual user names and scientific Program codes (from Summary 1 B), the units used by each investigator, and the percent of the total resource capacity this represents. A suggested format for this table is found below.

  ----------------------------- -------------- ------------ -------- -----------
  **Category of Users**         **Scientific   **\# of      **\#     **% of
                                Program        users in     Units    Total
                                Code(s)**      this         used**   Capacity or
                                               category**            usage**

  **Center members with any     []{.mark}      []{.mark}             
  active peer--reviewed                                              
  research funding during the                                        
  reporting period**                                                 

  Member name                                                        

  **Center members with no                                           
  active peer-reviewed research                                      
  funding during the reporting                                       
  period**                                                           

  Member name                                                        

  **Non-center members (number                                       
  only)**                                                            

  **Last 25% of users**                                              25%

  **Total**                                                          100%
  ----------------------------- -------------- ------------ -------- -----------

# Specific issues regarding certain shared resources:

## Informatics: Scientific progress depends increasingly on the management, sharing, and analysis of data from diverse sources. In cancer centers, informatics expertise and resources are critical shared resource functions. The CCSG may support applications of informatics directed toward cancer research (including the acquisition, maintenance, and integration of database systems for clinical trials or studies in populations; data extraction, storage, and analysis tools for genomics, proteomics, or molecular structure; a database annotating a research repository involving human specimens; and tools that enable sharing of data sets with collaborating investigators in related areas of research). Performance of specific research functions, such as data entry, for individual research projects or clinical trials is excluded.

As the interoperability of independently developed informatics systems
is an important goal of the research community, informatics development
efforts supported by CCSG funds must be in compliance with evolving
standards articulated by the NCI, the scientific community, and other
standard-setting organizations in the medical and bioinformatics areas.

**Dissemination Shared Resource:** While all cancers centers are
expected to share lessons learned from the center's research with the
wider scientific, public health, and clinical practice communities and
the public, some centers may elect to support a shared resource to
support dissemination *research*.

In your application, describe the contributions of the shared resource
to planning and evaluation of development-to-delivery activities of the
cancer center. Describe market analytical, needs assessment,
communication and other relevant dissemination analytical capabilities,
the number of investigators and Programs making use of the resource, the
audiences to whom research findings are being disseminated, and the
expertise of the *research* personnel dedicated to this task. Describe
the level of staff expertise in market research, audience analysis,
communications science as well as resources to systematically assess
target audiences preferences for cancer information, etc. More
information about NCI's research diffusion and dissemination programs
can be found at NCI's web site:
[http://cancercontrol.cancer.gov/d4d**/**](http://cancercontrol.cancer.gov/d4d/)**.**

**Imaging Shared Resource:** Imaging plays an increasingly important
role in cancer clinical trials. New functional, molecular imaging
methods require rigorous attention to standardization and quality
assurance issues. Most imaging is acquired in digital format, allowing
the information to be archived and processed in a variety of ways (e.g.,
volumetric measurements and computer-aided algorithms for detection and
analysis of lesions are possible). The budget for a shared resource for
imaging could include dedicated equipment for imaging in clinical
trials, imaging expertise for protocol development and quality control,
computer hardware and software for the acquisition, analysis,
integration and archiving of research image data, and personnel to
support these functions. It also might include partial salary support of
a radiologist or other imaging expert for expert consultation in
planning cancer center research projects or clinical protocols and
analyses for publication or required software.

Describe the location of the facility relative to center users, and
availability of space at each location for experimental set-up. Provide
specific examples of how the shared service has facilitated the
initiation of imaging projects for novice users. Provide current and
anticipated cancer-related research use, relative to the total use of
the facility, the recharge rates for animal and clinical scanners, and
recharge rates for funded projects without imaging budgets.

## Biostatistics: Biostatistics is a shared resource central to the mission of most centers, particularly those that perform clinical or population research. Participation by statisticians in many collaborative activities of the cancer center is eligible for CCSG support. Salary support is allowable for participation in cancer-center pilot projects, assistance to center investigators in conceptualizing and developing research projects, analyses for publication, and the development of methodology that is clearly and closely related to the support of specific projects within the cancer center. The CCSG is [not]{.underline} intended to support independent, investigator-initiated research in statistical methodology, for which statisticians, like other scientists, should be supported by project-specific grants. Nor is it typically intended to support a significant collaborative role on a funded research project, since the statistician would normally be supported by an appropriate time-and-effort allocation as a collaborator on that grant. CCSG support may be particularly useful for unanticipated needs for statistical collaboration arising in the center. 

## Clinical Protocol and Data Management Shared Resource: This resource provides central management and oversight functions for coordinating, facilitating, and reporting on, the cancer clinical trials of the institution(s) that define the center, whatever the study origin (local, industrial, cooperative group, or other). As a tool for management of a center's clinical research program, it complements the Protocol Review and Monitoring System. This resource provides a central location for cancer protocols, a centralized database of protocol-specific data, an updated list of currently active protocols for use by center investigators, and status reports of protocols. Quality control functions might include centralized education and training services for data managers and nurses, and data auditing. Data and safety monitoring functions are typically located within this shared resource. . Centers with complex clinical trials programs might choose to split these functions into separate resources. 

The resource allows oversight and quality control for the center's
entire clinical trials effort *but does not include tasks involved in
the actual direct conduct of individual trials (such as data entry)*.
Therefore, the CCSG request for this resource should not duplicate,
replace, or make up for reductions in funding provided through the
individual grants and contracts supporting the studies.

Peer evaluation of the request for CCSG support is based on the quality
of the management and oversight functions performed (i.e., system or
method and procedures, not individual patient files) and the quality and
diversity of the center's clinical trials effort.

**The following table is helpful in providing reviewers with an overview
of clinical trials accrual over the five year project period preceding
the competing renewal application. As it is a summary of Standard Cancer
Center Summary 4 data, definitions used in Summary 4 apply to the data
in this table. The form is intended as a template only and may be
adapted to fit a center's individual needs.**

**Summary of clinical research accrual:**

<table>
<colgroup>
<col style="width: 42%" />
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 8%" />
<col style="width: 2%" />
<col style="width: 8%" />
<col style="width: 1%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 10%" />
</colgroup>
<tbody>
<tr class="odd">
<td><blockquote>
<p><strong>Grant funding year</strong></p>
</blockquote></td>
<td colspan="2"><strong>1</strong></td>
<td colspan="2"><strong>2</strong></td>
<td colspan="2"><strong>3</strong></td>
<td colspan="2"><strong>4</strong></td>
<td colspan="2"><strong>Total</strong></td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>Calendar year</strong></p>
</blockquote></td>
<td colspan="2"><strong>200?</strong></td>
<td colspan="2"><strong>200?</strong></td>
<td colspan="2"><strong>200?</strong></td>
<td colspan="2"><strong>200?</strong></td>
<td colspan="2"><strong>Total</strong></td>
</tr>
<tr class="odd">
<td colspan="11"><strong>Accrual to Intervention Clinical Protocols By
Sponsor (Note: This correlates with the first 2 items</strong><a
href="#fn1" class="footnote-ref" id="fnref1"
role="doc-noteref"><sup>1</sup></a> <strong>under ‘Clinical Research
Category’ in Standard Cancer Center Summary 4)</strong></td>
</tr>
<tr class="even">
<td><blockquote>
<p>National Group</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>External Peer Review</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Institutional (investigator initiated)</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Industry</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>Total intervention accrual</strong></p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>% of subjects on institutional studies</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Total accrual at primary institution</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Total accrual at affiliate sites</p>
</blockquote></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="11"><strong>Accrual to Non-Intervention Clinical Studies by
Sponsor (Note: This correlates with the last 2 items</strong><a
href="#fn2" class="footnote-ref" id="fnref2"
role="doc-noteref"><sup>2</sup></a> <strong>under ‘Clinical Research
Category’ in Standard Cancer Center Summary 4)</strong></td>
</tr>
<tr class="odd">
<td colspan="2">National Group</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">External Peer Review</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Institutional (investigator-initiated)</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Industry</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>Total non-intervention accrual</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"><strong>Total intervention and non-intervention
accrual</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
</tbody>
</table>
<aside id="footnotes" class="footnotes footnotes-end-of-document"
role="doc-endnotes">
<hr />
<ol>
<li id="fn1"><p><sup>2</sup> Clinical trials involving an agent or
device or clinical trials involving other types of interventions (e.g.
behavioral modification, nutritional protocols, etc.)<a href="#fnref1"
class="footnote-back" role="doc-backlink">↩︎</a></p></li>
<li id="fn2"><p>Epidemiologic or other observational studies or
companion, ancillary, or correlative studies associated with a clinical
trial or other biological studies using clinical specimens that can be
linked to patient data.<a href="#fnref2" class="footnote-back"
role="doc-backlink">↩︎</a></p></li>
</ol>
</aside>

**9.2 Protocol Review & Monitoring System (PRMS)**: **Limited to 10
pages exclusive of protocol listing.** A particularly important function
for centers involved in clinical research is a mechanism for assuring
adequate internal oversight of the scientific aspects of all the cancer
clinical trials in the institution or institutions that formally
comprise the center (i.e., consortium centers should document that all
protocols are reviewed through a central PRMS). This function is
complementary to that of an Institutional Review Board (IRB), which
focuses on the protection of human subjects.

The PRMS is not intended to duplicate or overlap the responsibilities of
the IRB. Auditing, for either quality control or safety reasons, is
**not** a function of the PRMS. DSM committee functions and PRMS
committee functions are separate and distinct from one another and
should not overlap. The focus of the PRMS is on *scientific merit,
priorities, and progress* of the clinical protocol research of the
center. The PRMS should have the authority to open protocols that meet
the scientific merit and scientific priorities of the center and to
close protocols that do not demonstrate scientific progress. Quality
control concerns are not reflected in the evaluation of the PRMS, unless
the problem is so serious as to make the results of the protocols
meaningless.

With regard to scientific merit evaluation, the PRMS is expected to
evaluate all cancer center trials, whether derived and supported from
institutional sources or from industry. **However, the PRMS is not
required to duplicate traditional peer review, which includes
peer-reviewed protocols supported by the various NIH mechanisms (e.g.,
R0ls, U0ls, U10s, P0ls, and P50s), other approved agencies meeting the
NIH standard , and clinical research protocols approved by the NCI's
Cancer Therapy Evaluation Program or the Cancer Control Protocol Review
Committee.** These protocols may receive an expedited administrative
review for the purpose of prioritization. The PRMS also is *not*
required to studies dealing with healthy human subjects and the
population sciences, e.g., observational and epidemiologic studies.

All trials evaluated by the PRMS for merit, whether via full or
administrative review, have access to CCSG-supported centralized
resources, such as protocol and data management, informatics and
biostatistics.

-   **Description, Budget, and Justification**. Include a description, a
    budget, and a narrative budget justification. The budget may include
    appropriate personnel, administrative support, equipment appropriate
    to the task, and supplies.

-   **Describe the** **criteria for selection of the membership** of the
    committee. List the members of the committee and their expertise.
    The biographical sketches of these individuals should be included at
    the end of this section. Scientific expertise from basic, clinical,
    and population science/cancer control should be represented on the
    PRMS committee. While there may be limited overlap, committee
    representation should not duplicate that of the Data and Safety
    Monitoring Committee.

-   **Describe the** **procedures for scientific review and scientific
    monitoring** of cancer clinical trial protocols, including the
    criteria and process for submission of institutional clinical trial
    protocols to the committee for review and approval; the process for
    review of all cancer clinical research protocols of the institution;
    the review criteria that are used to assess scientific rationale,
    study design, expected accrual rates, adequacy of biostatistical
    input and feasibility for completion within a reasonable time
    period; and the criteria used for monitoring ongoing institutional
    protocol research to evaluate scientific progress, including
    reasonable accrual rates, to ensure that the scientific aims of the
    study can be completed.

-   **Describe the** **process and criteria used for prioritizing** the
    activation of cancer clinical protocols at the institution with
    respect to scientific merit and patient availability. Describe the
    input, if any, of disease focused Programs, to the prioritization
    process.

-   **Describe the process, criteria, and authority for terminating a
    clinical protocol**. Discuss whether the committee has ever
    terminated any protocols, and for what reason.

-   **Describe PRMS** **operations relative to the Institutional Review
    Board** (IRB) approval process with emphasis on the complementarity
    of the two entities and absence of overlap or duplication.

Provide a list of all i**nstitutional protocols** (i.e., studies that
have not received external review) that have been reviewed by the PRMS
for scientific merit or actively monitored for scientific progress in a
recent 12-month period (Grant year, January to December \[preferred
format\], or July through June). Indicate on that list those protocols
that were approved and activated, approved but yet activated, deferred
for revision, and disapproved.

For activated clinical trial protocols, provide target accruals and
accruals to date using the same format provided in Standard Cancer
Center Information, Summary 4, Clinical Research Protocol Information on
Clinical Research Studies.

Indicate for the same 12-month period how many protocols were monitored
for progress and performance and those that were closed, along with the
reason for closure. NCI will select a sample of the listed protocols for
detailed review prior to the site visit. Do *not* include or append
protocols to the CCSG application.

In cases of conditional approval or disapproval of the PRMS, the peer
reviewers will clarify in the Summary Statement what steps or changes
are needed for full approval, along with any recommendations on timing
of re-review by peers.

If the PRMS is conditionally approved, staff of the Cancer Centers
Branch will contact the PI by letter to request an application for
re-evaluation of the PRMS by the NCI Parent Committee (see Section III
below). The letter, with accompanying instructions, will be forwarded
approximately four months in advance of the review date recommended by
peer reviewers.

If the PRMS is disapproved, a funded grantee may request re-evaluation
of the PRMS during the grant project period. Centers interested in
re-evaluation should contact their program director for appropriate
guidance. Institutional protocols that have not been reviewed by
external mechanisms (e.g., CTEP) may not use CCSG-supported shared
resources.

######## The following table is helpful in providing reviewers with an overview of PRMS activity over the five year project period preceding the competing renewal application. In the section entitled 'Number of New Protocols Reviewed by Sponsor', each protocol would be counted only once. In the section entitled 'Number of Protocols' (shaded in gray), a protocol may be counted multiple times, depending on the number of actions taken on it by the PRMS committee. The form is intended as a template only and may be adapted to fit a center's individual needs.

######## Protocol Review and Monitoring System Grant Cycle 200X-200Y

  ----------------------------- ------------- -- ---------- ------------- ------------- -----------
  Grant year                    **1**            **2**      **3**         **4**         **Total**

  **Calendar year or**          **20??**         **20??**   **20??**      **20??**      

  **Academic Year**             **20??-??**      **20??-    **20??-??**   **20??-??**   
                                                 ??**                                   

  **Number of New Protocols                                                             
  Reviewed By Sponsor:**                                                                

  National Group                                                                        

  *SWOG*                                                                                

  *CCG*                                                                                 

  *Other*                                                                               

  External Peer Review                                                                  

  Industry                                                                              

  Institutional                                                                         

  **Number of Protocols:**                                                              

  Approved and activated                                                                

  Approved but not yet                                                                  
  activated                                                                             

  Deferred for revision                                                                 

  Disapproved                                                                           

  Monitored for scientific                                                              
  progress                                                                              
  ----------------------------- ------------- -- ---------- ------------- ------------- -----------

**9.3 Protocol-Specific Research Support: No more than 4 pages.** This
CCSG component provides support for short term, feasibility (e.g.,
pre-phase I, pilot) and phase I clinical trials originating from
scientific investigators within the cancer center. Preliminary data
generated from these trials, which historically have been only rarely
funded through other mechanisms, can be used as the basis for support of
later phase trials through competitive grant applications or industry.
Criteria for support are as follows:

-   Trials should be high priority, innovative, feasibility (i.e., pre
    phase I, pilot) and phase I institutional clinical interventions
    focusing on initial early phase testing of a candidate agent or
    device for the diagnosis, prevention detection or treatment of
    cancer. Support is not meant for all early phase trials, for later
    phase trials, or for studies that do that do not involve testing of
    an agent or device.

-   Trials must be conceptualized/designed by members of the center's
    research Programs.

-   Trials should typically be of short duration (e.g., less than one
    year).

-   Trials receiving support through other peer reviewed research
    grants, cooperative agreements, or contracts are ineligible for
    support through this mechanism. Trials may receive partial support
    from industry, assuming all other criteria are met.

-   The center's PRMS must be approved or conditionally approved by peer
    review for funding of positions requested.

-   Supported trials must be approved by the PRMS.

-   Funding is restricted to support of research nurses and data
    managers directly involved in the conduct of these trials. No other
    positions are eligible for support via this component (e.g.,
    pharmacist). Center leadership must oversee these funds (i.e., no
    funds are allowed for a core director or other supervisory
    functions).

Provide a listing of all trials supported with PSRS funds, with
investigator name, trial name, phase, anatomic site (if applicable),
duration, and outcome or impact (e.g., led to peer-reviewed funding for
a later phase trial, etc.). Discuss how trials are prioritized for
support. Base the budget request on the center's actual and projected
clinical trials activity, as well as on complexity of these protocols.

**10 Inclusion of Minorities and Women in Clinical Trials (NIH
Policy)**: **No more than 10 pages.** It is the policy of the NIH that
women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose
of the research. This policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the \"NIH Guidelines for Inclusion of
Women and Minorities as Subjects in Clinical Research"
([[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html));
a complete copy of the updated Guidelines is available at
[[http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm]{.underline}](http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm).

In your application, provide clear documentation on the accrual of women
and minorities into *interventional* clinical trials. If this section of
the application is not approved, a grant award *cannot* be issued until
a corrective plan and adequate response to the critique is submitted and
approved by NCI.

Reviewers evaluating the section of the application on the inclusion of
women and minorities in clinical research will consider separately
whether the accrual of women and minorities to therapeutic and
non-therapeutic trials is proportionate to the cancer patient population
in the cancer center\'s primary catchment area. Thus, separate tables
for accrual in therapeutic and nontherapeutic studies should be included
(accrual to epidemiologic, outcome, observational and other
non-interventional studies should not be included in these tables).
Reviewers will assess the total picture, taking **both** therapeutic and
non-therapeutic interventional clinical trial accrual into account in
relation to approval/disapproval of gender and minority accrual, per the
current review criteria in the CCSG Guidelines:

-   Appropriateness of the accrual of women and minorities to
    therapeutic and non-therapeutic clinical trials in proportion to the
    center's catchment area

```{=html}
<!-- -->
```
-   When accrual is inadequate, adequacy of center's plan to improve
    performance

When women or minorities are substantially under-represented, the
adequacy of the institution\'s policies, specific activities and a
corrective plan become critical in convincing peer reviewers that the
institution is serious about addressing the problem and is investing the
appropriate effort to correct under-accrual. In addition, if the
population of the catchment area of the cancer center has limited ethnic
diversity, provide a discussion of the institution's efforts to broaden
the ethnic diversity of its clinical trial accrual.

Include the following information in this section:

-   **Demographics**. Provide summary information showing the
    demographics of the primary geographic catchment area of the center
    by ethnic categories and subcategories and by gender , as well as
    for the cancer patient population treated at the cancer center.

-   **Accrual.** Complete Parts A and B of the "Inclusion Enrollment
    Report Table", found in the PHS Form (rev 11/07). Provide summary
    accrual information from the most recent 12-month period by ethnic
    categories and subcategories and by gender in the following two
    areas: (a) the therapeutic clinical trials conducted at the cancer
    center, and (b) the non-therapeutic trials conducted at the cancer
    center. Relate this information to the demographic information
    provided above.

-   **Deficiencies and Corrective Actions**. If there are any
    proportional deficiencies in the accrual of women and minorities to
    therapeutic and non-therapeutic trials relative to the opportunities
    as defined by the demographics of the center's catchment area, note:

    -   any general policies of the **institution** designed to help
        with this problem.

    ```{=html}
    <!-- -->
    ```
    -   unavoidable circumstances that impede accrual of women and
        minorities (e.g., a high proportion of non-eligible patients).

    -   actions planned or being taken by the **center**, based on
        careful analyses of the population, which demonstrate a clear
        effort to correct deficiencies that are potentially avoidable.

In addition, the revised PHS Form 398 instructions (rev. 11/07) require
applicants to provide data on the composition of *proposed* study
populations in terms of gender and racial/ethnic groups. *For CCSG
applications, this requirement is limited to projected accrual to phase
III studies that utilize CCSG resources and are not funded by any other
PHS grant mechanism.* See the PHS Form 398 (rev. 11/07) for table
formats for both targeted/planned enrollment and actual enrollment.
Please indicate if you have no phase III trials that meet this
criterion.

11. **Inclusion of Children in Clinical Trials: No more than 4 pages.**
    The NIH maintains a policy that children (i.e., individuals under
    the age of 21) must be included in all clinical research, conducted
    or supported by the NIH, unless there are scientific and ethical
    reasons not to include them.\
    \
    All investigators proposing research involving human subjects should
    read the \"NIH Policy and Guidelines\" on the inclusion of children
    as participants in research involving human subjects
    ([[http://grants.nih.gov/grants/funding/children/children.htm]{.underline}](http://grants.nih.gov/grants/funding/children/children.htm)).

As part of the scientific and technical merit evaluation of the research
plan, reviewers will be instructed to address the adequacy of plans for
including children (as appropriate for the scientific goals of the
research), or justification for exclusion.

**12 Data and Safety Monitoring**: **Limit of 5 pages if a budget is
requested; otherwise limit of 1 page.** Data and safety monitoring is
required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase
II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the
participants ("NIH Policy for Data and Safety Monitoring," *NIH Guide
for Grants and Contracts*,
[[http://grants.nih.gov/grants/guide/notice-files/not98-084.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not98-084.html)).

Provide a very brief summary of the Center's DSM Plan. Do *not* include
the entire DSM Plan within the text but provide a copy at the site
visit.

**DSM functions are distinct and should not be the direct responsibility
of the Protocol Review and Monitoring System (PRMS), which oversees
scientific aspects of cancer clinical trials. Do not merge these
activities and committees.**

By NIH review criteria, the peer reviewers will be responsible for
determining whether the plan is acceptable or unacceptable. Peers are
expected to define the weaknesses of an unacceptable DSMP and to reflect
any weaknesses in the priority score. The final approval of a DSMP in
its original form or later modified form is the responsibility of the
staff of the Cancer Centers Branch.

**If funding is being requested for DSM activities, provide *separate*
budget and justification pages including:**

-   A general description of DSM functions, including the workload
    related to evaluation, auditing, and monitoring of patient safety in
    institutional investigator-initiated studies and studies supported
    on competitive grants (e.g., R01s), and the flow and timing of DSM
    functions for studies, based on phase, level of risk, or other
    pertinent factors. Do not include DSM activities supported on other
    grants and contracts.

-   A description of the committees involved in DSM processes and the
    biographical sketches of the members of these committees.

If a budget for DSM functions is not separately distinguished in the
CCSG application, it will not be reviewed or funded.

**13** **Federal Citations Relevant to CCSG Applications**

**Use of Animals in Research:** Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane
Care and Use of Laboratory Animals
([[http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf]{.underline}](http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf))
as mandated by the Health Research Extension Act of 1985
([[http://grants.nih.gov/grants/olaw/references/hrea1985.htm]{.underline}](http://grants.nih.gov/grants/olaw/references/hrea1985.htm)),
and the USDA Animal Welfare Regulations
([[http://www.nal.usda.gov/awic/legislat/usdaleg1.htm]{.underline}](http://www.nal.usda.gov/awic/legislat/usdaleg1.htm))
as applicable.

**Human Subjects Protection:** Federal regulations (45 CFR 46) require
that applications and proposals involving human subjects must be
evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research
to the subjects and others, and the importance of the knowledge gained
or to be gained
([[http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm]{.underline}](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)).

**Sharing Research Data:** Investigators submitting an NIH application
seeking \$500,000 or more in direct costs in any single year are
expected to include a plan for data sharing or state why this is not
possible
([[http://grants.nih.gov/grants/policy/data_sharing]{.underline}](http://grants.nih.gov/grants/policy/data_sharing)).

You must submit a plan for data sharing if the CCSG provides direct
support for the generation or storage of research data (e.g., pilot
projects supported through developmental funds, early phase clinical
trials conducted with funds from Protocol Specific Research Support) or
funds shared resources that serve as the final repository of data (e.g.,
a high throughput DNA array analysis resource, family registries). If
you are requesting a budget for data-sharing activities (e.g., data
archiving), include the budget and justification with this section.

NCI Program staff is responsible for assessing the appropriateness and
adequacy of the proposed data sharing plan and budget. Reviewers do not
review the proposed data sharing plan, thus it is not factored into the
determination of scientific merit or priority score.

**Policy for Genome-Wide Association Studies (GWAS):** NIH is interested
in advancing genome-wide association studies (GWAS) to identify common
genetic factors that influence health and disease through a centralized
GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across
the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight),
or the presence or absence of a disease or condition. All applications,
regardless of the amount requested, proposing a genome-wide association
study are expected to provide a plan for submission of GWAS data to the
NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data
repository management (submission and access) is governed by the Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, [NIH Guide
[NOT-OD-07-088]{.underline}](http://www.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
For additional information, see
[<http://grants.nih.gov/grants/gwas/>.]{.underline}

Peer reviewers will assess the application to assure that a plan is
provided for any GWAS studies supported through CCSG elements. Program
staff is responsible for assessing the appropriateness and adequacy of
proposed data sharing plans. Program concerns regarding data sharing
plans must be resolved prior to making awards.

**Sharing of Model Organisms:** NIH is committed to support efforts that
encourage sharing of important research resources including the sharing
of model organisms for biomedical research (see
[[http://grants.nih.gov/grants/policy/model_organism/index.htm]{.underline}](http://grants.nih.gov/grants/policy/model_organism/index.htm)).
At the same time the NIH recognizes the rights of grantees and
contractors to elect and retain title to subject inventions developed
with Federal funding pursuant to the Bayh-Dole Act (see the *[[NIH
Grants Policy
Statement]{.underline}](http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#__RefHeading___Toc54600131))*.
Beginning October 1, 2004, all investigators submitting an NIH
application or contract proposal are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using
NIH funding or state why such sharing is restricted or not possible.
This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing
plan is not subject to a cost threshold in any year and is expected to
be included in all applications where the development of model organisms
is anticipated.

Provide a short description of the center's institutional approach for
adhering to the model-sharing policy, as well as specific model sharing
plans for any research conducted directly with CCSG funds (i.e., pilot
projects conducted with developmental funds) or components serving as
research resources (e.g., mouse model and transgenic mouse shared
resources , etc.). The adequacy of plans for sharing model organisms
will be considered by reviewers when a competing application is
evaluated. An assessment of the plan will be provided in an
administrative note, but will not affect the overall priority score. If
you are requesting a budget for model-sharing activities, include the
budget and justification with this section.

**Links to Other Federal Citations:**

-   Access to Research Data through the Freedom of Information Act:\
    [[http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm]{.underline}](http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm).

-   Required Education on the Protection of Human Subject Participants:\
    [[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html).

-   NIH Public Access Policy Requirement:
    [[http://www.pubmedcentral.nih.gov/]{.underline}](http://www.pubmedcentral.nih.gov/);
    [<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html>;
    <http://publicaccess.nih.gov/>]{.underline}.

-   Standards for Privacy of Individually Identifiable Health
    Information:
    [[http://www.hhs.gov/ocr/]{.underline}](http://www.hhs.gov/ocr/);
    [[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html).

-   Authority and Regulations:
    [[http://www.cfda.gov/]{.underline}](http://www.cfda.gov/)

-   Healthy People 2010:
    [[http://www.health.gov/healthypeople]{.underline}](http://www.health.gov/healthypeople)

-   Loan Repayment Programs:
    [[http://www.lrp.nih.gov/]{.underline}](http://www.lrp.nih.gov/)

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-   Human Embryonic Stem Cells (hESC):
    <http://stemcells.nih.gov/index.asp>;
    <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html>;
    http://escr.nih.gov

1**4 Appendices:** After the application has been submitted, the
applicant should contact the Scientific Review Officer (SRO) to discuss
the inclusion of any appendix materials that are important to peer
review. Only materials approved by the SRO will be included in
appendices for peer review.

**15 Review Materials to be Available Before the Full or Limited Site
Visit:** Forward the following materials to the Scientific Review
Officer (SRO) for use during the pre-site visit meeting, and have an
additional set available at the site visit:

-   Biographical sketches of all cancer center members. A complete set
    of biographical sketches facilitates the review particularly if it
    is available to the Scientific Review Officer for use during the
    pre-site visit meeting of reviewers.

-   An updated Summary 2, Active Funded Projects from the Standard
    Cancer Center Information Summaries, and in the same format , if
    desired, a *separate* list of grants and contracts *pending* peer
    review, approval and funding.

-   An updated a list of the clinical research by scientific Program,
    where applicable, using the definitions and sort order specified in
    the instructions for Summary 4.

-   Copies of the data to be presented in the posters. Do not send
    reduced size copies of the full poster as these are not usually easy
    to read.

Have available at the site visit:

-   Institutional protocols that have been reviewed by the center's
    Protocol Review and Monitoring Committee.

-   Copies of the minutes or reports of external and internal advisory
    committees (e.g., the center's Executive Committee), retreats, and
    other meetings relevant to the planning and evaluation process for
    the center.

-   Log books or other records of use for all shared resources.

-   The complete institutional Data and Safety Monitoring Plan.

**16 Application for Comprehensiveness**

**16.1 First-Stage Review for Comprehensiveness (Scientific Elements):**
The determination of whether a cancer center will be designated as
"comprehensive" (see page 4 for definition) by the NCI is a two-step
process. In the first step, peer review determines whether the center
fulfills the broad scientific and interactive requirements for
comprehensiveness as described elsewhere. Unless a center advises the
SRO in advance of the review that they choose not to be considered for
comprehensiveness, the Parent Committee will evaluate the scientific and
interactive aspects of comprehensiveness as an integral part of the
overall review of the Cancer Center Support Grant application.

In consortium centers, a comprehensive designation may be based on
research in the primary institution alone, or on supplemental strengths
of the research in all consortium institutions. Grants of the partner
institutions may be counted toward Program eligibility and calculation
of the CCSG/NCI funding ratio, pending a successful peer review.

Questions regarding the comprehensiveness review should be directed to
NCI Program staff after the final summary statement is received.

**16.2 Second-Stage Review for Comprehensiveness (Education and Training
of Biomedical Researchers and Professionals and Community Service and
Outreach, No more than 20 pages):** Many organizations that are
dedicated exclusively to health care call themselves comprehensive
cancer centers based on their self-assessment of their prevention,
diagnostic, and treatment services. However, the term "comprehensive" as
used by the NCI requires more than state-of-the-art care and services
and includes a strong research base interactive with a wide spectrum of
prevention, care, education, information and dissemination activities
that broadly serve their local and regional communities and often the
nation. These activities are supported by a broad array of Federal and
non-Federal funding sources, such as research grants and contracts;
prevention and control, training, and education grants; state awards;
and private donations.

If peer review approves the *scientific* requirements for
comprehensiveness, and the CCSG application is funded at any level,
staff of the Centers Branch will contact the PI by letter to request a
summary of the institution's programs in lay and professional outreach
and education. Applicants will be given approximately six weeks to
prepare and submit materials. The Parent Committee then determines
whether to recognize the center as comprehensive based on the
documentation provided. Since second stage reviews are typically
scheduled only once per year, the interim between the first- and
second - stage reviews may be as much as a year, depending on the timing
of the center's original application date.

### Instructions for Application for Second-Stage Review of Comprehensiveness 

### Education and Training of Biomedical Researchers and Health Care Professionals: The cancer center must sponsor or participate in education and training of biomedical researchers and health care professionals. Training of biomedical researchers includes appropriate programs for training MDs, and PhDs in laboratory, clinical and public health research (including cancer prevention and/or cancer control research). Cancer centers also should sponsor continuing education programs for practicing health care professionals (e.g., technicians, nurses, physicians) in the community or region served by the cancer center. These activities should cover a spectrum of topic areas, including early detection, diagnosis, treatment, and rehabilitation, and quality of life. Programs focused on cancer prevention and on encouraging community health care professionals to accrue patients to cancer clinical trials should also be provided.

> For this section of the application:

-   In Summary 2 format, provide a listing of training grants that
    support the award of degrees in nursing, behavioral sciences, and
    medicine, and that promote the specialized skills needed to practice
    in medical, surgical, radiation, and pediatric oncology, as well as
    rehabilitation, pain management, psychosocial services, and other
    relevant fields.

-   Describe briefly your training activities in these areas.

-   Indicate the total number of trainees and the number of
    under-represented minorities and special populations recruited to
    these programs.

-   Discuss your minority recruitment efforts in the narrative,
    including significant accomplishments and hurdles.

-   List the continuing education programs conducted by your center for
    health care professionals and briefly summarize these efforts in a
    narrative description.

    -   **Community Service and Outreach:** A comprehensive cancer
        center must define the local community or region that it serves,
        and maintain productive service and outreach efforts to address
        issues of greatest concern to that community. When the service
        regions of comprehensive cancer centers overlap, centers must
        work with or complement each other. Programs or activities must
        address cancers of highest incidence, morbidity and mortality
        within the community and the region, and the needs of
        populations with disproportionate cancer incidence and mortality
        rates (e.g., minorities, Native Americans, people over age 65).
        Through leadership, technical assistance, advice, and other
        services, comprehensive cancer centers must facilitate NCI
        funded outreach programs (e.g., CIS) the programs of other local
        organizations (e.g., State Health Departments, State Cancer
        Plans, American Cancer Society Divisions), in their service
        area, as well as sponsor and encourage other local efforts
        through community organizations (e.g., hospices, support
        groups), hospitals and businesses.

> For this section of the application:

-   Define the center's local catchment area in terms of geography and
    population demographics, and discuss relevant cancer issues and
    problems.

-   Discuss how the center establishes priorities and uses its available
    expertise and resources to address cancer incidence and mortality
    among populations within the defined catchment area.

-   Provide a listing of service and outreach activities within the
    catchment area, including those that address the special cancer
    problems within the community.

-   Discuss your service and outreach efforts in the narrative,
    including those oriented to special populations, and provide any
    supporting documentation.

-   Discuss collaborative service and outreach efforts with for profit
    or not for profit programs, as well as with other centers, community
    hospitals, and private oncology practices in overlapping service
    areas and provide a listing of these collaborations.

-   Discuss how the center evaluates the impact of its service and
    outreach activities.

**16.3 One-time Opportunity to Reapply for Comprehensiveness:** A funded
grantee that fails to receive the comprehensive designation at either
the first or second stage of review may re-apply once during the grant
project period. The re-application, which should address reviewer
concerns, will be evaluated by the Parent Committee. Centers interested
in re-application should contact NCI program staff for further
information.

**16.4 Retaining the Comprehensive Designation:** If an NCI-designated
Comprehensive Cancer Center's competing renewal application meets the
scientific standards for comprehensive recognition from the Parent
Committee but is voted a priority score that does not merit funding, the
center may retain the NCI comprehensive designation only for as long as
the NCI maintains the "active" status of the CCSG through administrative
actions.

**Instructions for Submitting the CCSG Application**

**Where to Send the Application:** Submit one original and **3 copies**
of the CCSG application to the Center for Scientific Review (CSR), NIH,
according to the instructions in the PHS Form 398 (rev. 11/07) kit. For
a new or competing continuation application, enclose a cover letter
naming the NCI staff person who agreed to accept the application for
consideration.

At the same time the application is submitted to CSR, please send two
complete copies to the NCI at the address below to facilitate scheduling
and determination of whether additional information is needed for the
review. The NCI address is:

Referral Officer

> National Cancer Institute
>
> 6116 Executive Boulevard, Room 8041, MSC 8329
>
> Bethesda, Maryland 20892-8329 (for Express mail use Rockville, MD
> 20852)
>
> Tel: 301/496-3428
>
> Fax: 301/402-0275

**Acceptance of the Application:** A Scientific Review Officer (SRO),
located in NCI's Division of Extramural Activities oversees the
peer-review process. Between submission and the completion of the peer
review process, direct all communication to the SRO responsible for the
CCSG review. The SRO supervises the review process to ensure a
technically competent and unbiased review. While the application is in
review, the SRO may consult NCI program staff on program policies and
guidelines.

Upon receipt of an application, the SRO conducts a thorough review of
the submitted materials with attention to the following elements:

-   **Conformity with Guidelines:** Applications should exhibit the
    general organizational, administrative, and operational structure of
    cancer centers and request allowable and appropriate costs as per
    these guidelines.

-   **Format:** Applications should be prepared in conformity with the
    PHS Form 398 (rev. 11/07) instructions to facilitate review of the
    submission. It is very much in the applicant\'s interest that review
    of these complex applications be as trouble-free as possible for
    peer reviewers.

-   **Completeness of Required Information:** The applicant should
    ensure that all essential information is presented completely and
    unambiguously, to facilitate the quality and consistency of the
    review.

If an application is deficient in the elements above, depending upon the
magnitude of the problem, the SRO may:

-   request additional clarifying information or revised materials from
    the applicant.

-   accept for review only those parts of the application prepared in
    accordance with the CCSG guidelines.

-   defer the application to a later review cycle.

-   return the application to the applicant without review.

In addition, peer reviewers have the option of reducing the merit, or
'not recommending for further consideration', any element in the
application that they feel is inadequately documented to allow for a
full and fair judgment.

**Modifications After Submission:** Minor, unavoidable modifications of
the application can be accepted up to 6 weeks prior to the site visit.
Major modifications, however, may result in deferral by the SRO to the
next round of receipt and review. Generally, new material should not
represent major changes in the application as written and/or presented.
Whether to accept modifications of the application or additional
information or to defer the application rests entirely with the SRO.

Reviews will be based on the material submitted at least **6 weeks**
prior to the site visit. Do not submit additional material after that
time unless specifically requested.

# Inquiries About the Application after Submission:

-   **Before Completion of NCI Parent Committee Review:** Direct
    inquiries to the SRO, who is responsible for all aspects of the peer
    review process.

-   **After completion of the NCI Parent Committee Review,** address
    questions to the responsible program director in the Cancer Centers
    Branch (CCB) or to the Chief of the CCB or, for fiscal questions,
    the Grants Management Specialist.

-   ***Applicants may not contact any member of the site visit or the
    parent review committees about the review.***

> **III Peer Review of the Application**

**Types of Review**

All CCSG applications undergo peer review under the authority and
responsibility of the Scientific Review Officer (SRO). Site visit
committees gather information for final evaluation by the Parent
Committee (NCI Initial Review Group Subcommittee A or NCI IRG A). A full
site visit encompass a review of all application components. In some
circumstances, a grantee may elect a limited site visit, which focuses
only on the administrative, regulatory, clinical, and financial aspects
of the application and center, including institutional commitment,
administration, and clinical trials oversight (clinical trials office,
protocol review and monitoring system, protocol specific research
support, and data and safety monitoring).

Full site visit review is required for new applicants, for centers
seeking an increase in funding of greater than 10% compared to the final
year of their prior award or a change in designation, or for centers
with a new director or other significant change. Full site visits may
also be requested by any center director.

Limited site visits are only available to funded centers that have had
no change in director since the last review, are requesting a budget
increase of less than 10%, and have no other significant changes,
including a request for a change in designation. Center directors should
consult with NCI program staff before requesting a limited site visit to
ensure that they understand the implications of this decision. Program
staff will indicate eligibility for a limited site visit in the Prior
Approval of Acceptance letter to the applicant.

The SRO contacts the center director well in advance of the site visit
date to decide on the appropriate length of time for the site visit,
discuss the proposed agenda, and coordinate other site visit logistics.
To plan the review, the Scientific Review Officer may request
preliminary information, including a decision on the option of a limited
site visit, several months prior to the actual application receipt date.

Proper review of a complex center, whether at site visits or at the
deliberations of the parent committee, requires evaluation by peers:
scientists with substantial experience, a broad perspective on cancer
research, and scientific, organizational, and administrative
sophistication. Peers may be drawn from cancer centers or institutions
without centers. Those who have not served on at least one center site
visit in the last 3 years will undergo an orientation.

-   **Full site visit reviews**:

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-   A full review team will visit the center for presentations and
    discussion. The separate administrative review during the site visit
    will be as short as possible, based on the completeness of the
    application, to permit center administration to attend the site
    visit presentations.

-   Full site visits usually extend a maximum of 8 hours at the center,
    depending on the size and complexity of the application and center.
    Centers are encouraged to present formal scientific Programs in
    groups rather than individually to allow more time for discussion,
    and must present shared resources in a poster session format, so
    that reviewers can focus more of their time on the Center's
    scientific Programs.

-   A written report of the site visit is provided to the applicant for
    factual corrections prior to the application's final review by the
    parent committee.

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-   **Limited site visit reviews**:

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-   Four to six weeks prior to the Parent Committee meeting, NCI staff,
    an administrative reviewer and several investigators with clinical
    trials expertise will visit the center to evaluate the
    administrative, regulatory, clinical, and financial aspects of the
    application and center, including institutional commitment,
    administration, and clinical trials oversight (clinical trials
    office, protocol review and monitoring system, protocol specific
    research support, and data and safety monitoring).

-   Four weeks prior to the Parent Committee meeting, regular and ad hoc
    parent committee members will submit questions generated from review
    of the paper application for clarification to the SRO; these will be
    forwarded to the applicant.

-   Two weeks prior to the Parent Committee Meeting, the cancer center
    will provide written responses to the submitted questions.

-   At the Parent Committee Meeting:

    -   The center director and administrator may each give a
        presentation of no more than 10 minutes and respond to questions
        from the committee

    -   Limited site visit team reviewers will present their findings.

    -   The Parent Committee, supplemented by individuals with expertise
        appropriate to the scientific research described in the
        application, will discuss and evaluate each element of the
        application.

-   Because of the limited reviewer-applicant interactions, the
    submitted application must be complete.

**Parent Committee Review:** The Parent Committee, is a chartered review
committee of the NIH. After considering the written report of the site
visitors, the viewpoints of NCI Parent Committee members who
participated in the site visit, response of the applicant to the site
visit report (in the case of a full site visit), and the deliberations
of the full committee, it provides a final merit evaluation and a budget
recommendation for the CCSG application in a Summary Statement, which is
provided to the principal investigator as soon as available.

The Parent Committee also determines if the ***scientific*** (Stage I)
criteria for comprehensiveness are met. If so the Center is invited by
NCI Program Staff to submit additional material addressing the
***education, training, service and outreach*** (Stage II) criteria for
comprehensiveness. The Parent Committee determines comprehensiveness at
a subsequent meeting after review of this additional material.

**Ad hoc Review:** Whenever conflicts of interest exist within the usual
two-step peer review system of site visit and NCI Parent Committee ,
(e.g., an application submitted from the institution of a NCI Parent
Committee Cancer Center Director), the SRO will conduct a single step ad
hoc review in lieu of the usual two-step process.

**National Cancer Advisory Board (NCAB):** The NCAB is the final step in
the peer-review process. The NCAB may concur with all peer-review
recommendations, ask for re-review, or make some other recommendation.
NCAB approval must precede funding.

Final funding decisions are made in accordance with the NCI's budgets
for the Cancer Centers Branch during each fiscal year.

### 

### Criteria for Peer Review for Competing CCSG Applications

**Overview:** Cancer centers have a number of appropriate
missions---research, education, and care. Nevertheless the CCSG
predominantly supports the research mission of the center. The role of
peer review is to assess the extent to which the center has promoted or
is likely to promote excellence in research that may lead to a reduction
in the incidence, morbidity, and mortality attributable to cancer to
persons within their catchment area and beyond. Reviewers also evaluate
how well the center's leadership, organization, and processes for
development and evaluation facilitate scientific productivity,
strengthen the institution's research capabilities, and enable its
investigators to take advantage of scientific opportunities beyond what
would have likely occurred at the institution without the CCSG.

Successful cancer centers:

-   have a strong peer-reviewed research base in cancer-related science.

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-   add tangible value to the research base already in place within the
    institution.

-   meet all six essential characteristics of an NCI-designated Cancer
    Center.

**Reviewing Science in the CCSG:** Science, not process, is the focus of
the review. Even when process is to be specifically evaluated, such as
with planning and evaluation or the ways in which flexible funds are
utilized, the criteria for success are the scientific judgment behind,
or consequences of, particular actions or decisions. In a CCSG review,
assessment of scientific quality differs importantly from the familiar
peer review of individual grants. It is not the role of peer review to
re-examine individual projects that have already received fundable
priority scores. Rather scientific review of a CCSG should seek to
address 6 major issues:

-   What is the overall quality of the science in the center?

-   What impact has the center itself had (or is it likely to have) on
    the quality of the science, the productivity of the scientists, and
    the transdisciplinary activities of the institution relating to
    cancer?

-   What has the center contributed to the development of more effective
    prevention, diagnosis and treatment for cancer (where appropriate)?

-   Does the cancer center *add value* over and above the separately
    funded research efforts themselves? Have thoughtful, coherent
    scientific Programs been assembled and Program members selected to
    maximize the *cancer-related* interactive science in the parent
    institution as a whole?

-   How do the different cancer-related scientific themes in the parent
    institution fit together in the center?

-   Have the choices for center membership made by its leaders resulted
    in a group of excellent cancer -focused scientists who are also
    committed to productive interactions with one another.

**Assessing Merit Despite Institutional Diversity:** The peer-review
process will evaluate scientific merit and the value-added by the center
across a great variety of institutions. Small institutions compete
directly with large ones; centers organized only recently compete
against distinguished cancer-research organizations which have existed
for decades. In several instances, the center is comprised of a
consortium of scientific institutions. NCI encourages peer review to
recognize and reward scientific excellence, diversity and the variety of
organizational forms. The flexibility inherent in these CCSG guidelines
should result in the funding of centers with a variety of scientific
agendas

The intentionally non-restrictive nature of CCSG requirements should
allow constructing scientifically excellent centers around very diverse
themes. ***Scientific excellence is not synonymous with large size.***
Smaller institutions may develop a limited number of scientific Programs
that capitalize on their specific scientific strengths or special
populations. The primary consideration for reviewers is the merit of the
Programs presented, not their number or size.

**Some Restrictions on Allowable Budgets:** Requested and/or awarded
funds may not duplicate or replace costs normally included in the
institution's indirect cost base or various services and benefits
normally provided by the institution (e.g., purchasing services,
personnel services, and other ancillary services) in support of other
research organizations (other centers, departments, institutes, etc.).
In general, CCSG funds should not be used to compensate for NIH/NCI
administrative reductions of active research grants, cooperative
agreements, and contracts. CCSG funds may not be used to pay for
shortfalls in funded research projects due to over-expenditures on the
funded project or NIH reductions in awards. The CCSG funds are not
intended to supplement or offset any patient costs, even those directly
related to clinical research protocols, including costs for parking,
taxi fares, meals, or hotel rooms. The cost of clinical trials should be
supported by their respective funded research projects. The CCSG,
however, may support research pilot studies as allowed by the
developmental funds and protocol specific research function, for
institutional feasibility (pre-phase I) and phase I, PRMS-approved
interventional clinical protocols. Signatures by the principal
investigator and the business official on the face page of the CCSG
application officially attest that all of the requested costs comply
with these conditions.

To assure stringent and fair review across the diverse range of
institutions applying for CCSG support, consider the following specific
review criteria in evaluating the merit of the CCSG application and its
key sections:

**Essential Characteristics of the Center -- Guidelines Section Parts I
and II, 6.0 (merit descriptor for each)**

##### *Facilities* 

-   adequacy and appropriateness of the center's space & physical
    facilities in relation to its identity, objectives, activities.

#### *Organizational Capability*

-   effectiveness of the center's organization in taking full advantage
    of institutional capabilities in cancer research and in fostering
    scientific interactions and joint initiatives among programmatic
    elements.

-   adequacy and appropriateness of membership criteria; documented
    processes for evaluation of members, including non-aligned members,
    on a periodic basis, and compliance with these policies and
    procedures.

-   effectiveness of the center in use of external and internal cancer
    center advisory bodies (e.g., executive committee) for strategic
    planning, decision making, and priority setting.

-   for consortium centers, adequacy of mechanisms in place to ensure
    that:

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-   differences can be resolved among consortium institutions.

-   benefits of clinical research are uniformly available across
    consortium institutions to the population within the catchment area.

-   strategic goals of the center are being met through an integrated
    recruitment process.

-   the center director has authority over all shared resources in
    CCSG-supported shared resources in collaborating institutions and to
    integrate scientists from all partner institutions into the
    scientific Programs of the center.

-   all members have appropriate access to shared resources, participate
    in scientific Programs, and may assume leadership positions in the
    center, even if partner institutions are geographically dispersed.

***Transdisciplinary Collaboration***

-   level of effective transdisciplinary and translational
    collaborations among laboratory, clinical, and population science
    cancer center members and adequacy of mechanisms used by center to
    promote them.

-   extent to which collaborative activities within and among (inter-
    and intra-programmatic) Programs have added value to cancer related
    scientific activities.

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-   for consortium centers, adequacy of mechanisms in place to ensure
    that:

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-   research is integrated across partner institutions as evidenced by
    programmatic structure and objectives, joint publications and grants
    and other transdisciplinary, cross institutional activities.

> \- the partnership is stable, as evidenced by a history of research
> integration (see above) and the provisions of formalized legal
> agreements.

#### *Cancer Focus* 

-   breadth, depth, and significance of the cancer research base, as
    judged by the structure and objectives of the Programs, research
    support, and collaborative publications of center members

***Institutional Commitment***

-   extent to which the institution has met prior commitments and
    provided (or plans to provide) resources to insure that the center
    reaches its full potential.

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-   for matrix centers, evidence that cancer center status is at least
    equivalent to that of an academic department..

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-   adequacy of:

    -   space, positions and discretionary funds controlled by the
        center director.

    -   cancer center access to clinical inpatient and outpatient
        facilities for the conduct of clinical trials.

    -   oversight of faculty and staff critical to clinical research.

    -   the institution's plan to deal with a change in the directorship
        of the center.

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-   for consortium centers, adequacy of mechanisms in place to ensure
    that:

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-   the partnership is stable, as evidenced by a history of research
    integration (see above) and the provisions of formalized legal
    agreements.

-   the center director has authority over all shared resources in
    CCSG-supported shared resources in collaborating institutions and to
    integrate scientists from all partner institutions into the
    scientific Programs of the center.

#### *Center Director* 

-   appropriateness of the scientific and administrative qualifications
    and experience of the director in relation to the center's research
    activities and objectives.

-   appropriateness of the director's position within the institution
    (at least that of a department chair) and his/her representation on
    decision making committees relevant to center objectives.

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-   appropriateness of the director's time commitment to the center's
    research activities.

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-   adequacy of the director's formally codified authority over (and
    effectiveness in management of) the center's space and research
    resources, including:

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-   appointment of new members and discontinuation of existing members.

-   appointments of faculty necessary to enhance the research objectives
    of the center.

-   inpatient and outpatient facilities necessary to achieve the
    center's clinical research objectives (in centers with clinical
    research activities).

-   philanthropy, clinical revenues, or other funding streams.

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-   for consortium centers, adequacy of mechanisms in place to ensure
    that the center director has authority over all shared resources in
    CCSG-supported shared resources in collaborating institutions and to
    integrate scientists from all partner institutions into the
    scientific Programs of the center

**Senior Leadership -- Guidelines Section Part II, 7.1 (merit
descriptor)**

-   appropriateness of the qualifications and effectiveness of each
    senior leader in relation to his/her role in the research activities
    of the center.

-   appropriateness of the time commitment of each leader in relation to
    needs and objectives and to the difficulty and complexity of his/her
    responsibilities.

-   effectiveness of the team in working together as a group in
    addressing cancer center issues and planning strategies.

**Planning and Evaluation -- Guidelines Section Part II, 7.4 (merit
descriptor)**

-   effectiveness of external and internal advisory and evaluation
    activities on the development of the center's scientific activities.

-   appropriateness of the External Advisory Committee relative to the
    center\'s needs.

-   effectiveness in using the External Advisory Committee as a group,
    based on:

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-   annual meetings of the committee as a whole.

    -   production of a committee report with recommendations to the
        center director.

    -   response to committee recommendations by center and
        institutional leadership.

**Developmental Funds -- Guidelines Section Part II, 7.5 (merit
descriptor)**

-   effectiveness in (or potential for) strengthening the centers
    identified strategic scientific needs, including use of funds in the
    prior project period, where applicable.

-   effectiveness in (or potential for) assessing scientific merit of
    research opportunities proposed by center members.

-   effectiveness of the center in use of internal and external advisory
    bodies to assist in identifying scientific opportunities and needs
    appropriate for the investment of developmental funds (development
    of new shared resources and areas of recruitment).

**Staff Investigators -- Guidelines Section Part II, 7.3 (for each
individual requested: approval as requested, or at a lower percent
effort, or disapproval)**

-   For Research Staff Investigators:

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-   service as Principal or Co-Investigator on at least one NCI approved
    peer-reviewed and funded research project

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-   special, clearly definable role in helping the center achieve its
    scientific objectives (above and beyond own research support and
    those duties encompassed in another CCSG role, such as senior or
    program leader) .

-   extent to which the investigator's proven record of scientific
    productivity and accomplishments, as well as current peer-reviewed
    support, justify the request for support.

    -   For Clinical Staff Investigators:

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-   special, clearly definable role in helping the center achieve its
    clinical objectives (above and beyond own clinical research
    activities and those duties encompassed in another CCSG role, such
    as senior or program leader).

-   extent to which participation in the development and implementation
    of the center's clinical activities (e.g., authorship of clinical
    trials, accrual of patients on interventional trials, or leadership
    roles in cooperative group studies) promotes the center's clinical
    and translational goals and therefore justifies the request for
    support.

**Scientific Quality of Each Program -- Guidelines Section Part II, 8.0
(merit descriptor for each Program)**

-   overall scientific quality of the Program.

-   extent of cancer focus.

-   extent to which the relevant scientific disciplines that enhance
    Program breadth and depth and maximize productivity are represented.

-   extent of value added by the Program in promoting transdisciplinary
    and translational research among its members and with members of
    other Programs.

-   judicious and justifiable selection of members of the Program, based
    upon evidence of participation.

-   effectiveness of Program leaders.

-   appropriateness of the percent effort requested for the Program
    leader in relation to the difficulty and complexities of his/her
    responsibilities.

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-   extent of value added by the Program to the center.

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-   interactivity of the Program as documented by agendas of Program
    meetings (minutes not required) and inter- and intra-programmatic
    publications. Of total publications, 10% inter- and 10%
    intra-programmatic publications constitute general benchmarks for a
    reasonably interactive Program. Publications should represent the
    broad diversity of Program members.

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-   for clinical and translational Programs, effectiveness in accrual of
    patients to all types of trials in relation to the patient
    population. This includes investigator initiated institutional
    trials; those that demonstrate leadership, interaction, and
    collaboration in other NCI-funded clinical programs, such as
    Cooperative Groups, SPOREs, and other multi-site clinical trial
    networks; and collaborative trials with industry.. A total of 10%
    accrual to therapeutic and prevention trials constitutes a general
    benchmark for a reasonable level of protocol accrual.

-   for consortium centers:

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-   all members participate in scientific Programs and may assume
    leadership positions in the center, even if partner institutions are
    geographically dispersed.

-   research is integrated across partner institutions as evidenced by
    programmatic structure and objectives, joint publications and
    grants, and other transdisciplinary, cross institutional activities.

**Overall Quality of the Programs**

-   overall scientific quality of the Programs.

-   value added by the Programs to the center.

**Center Administration -- Guidelines Section Part II, 7.6 (merit
descriptor)**

-   appropriateness of the qualifications of administrative staff.

-   appropriateness of policies regarding use of cancer center space.

-   effectiveness of administration:

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-   in providing centralized administrative services important to the
    research activities of the center in center decision-making
    processes

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-   in oversight of shared resources.

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-   in budget, purchasing, and accounting processes.

-   in support of faculty recruitment, payment, and review; membership
    application policies and process; arranging and documenting meetings
    organized by the center; and management of pilot projects review and
    awards.

-   in representing the center within the institution, including the
    central grants office (e.g. level of support, assignment of
    applications and grants for center members, and overlap of
    functions), and clinical (e.g., in-patient, out-patient, and
    networks), and other pertinent entities.

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-   for consortium centers, adequacy of mechanisms to ensure smooth
    administration of CCSG functions across institutions.

**Shared Resources and Services -- Guidelines Section Part II, 9.0
(merit descriptor for each resource)**

-   extent to which resource provides services to multiple investigators
    in the center.

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-   extent to which the resource is strategically important to the
    science of the center.

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-   quality of the science the resource supports.

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-   quality of the product and cost-efficiency of the service (e.g.,
    whether quality and costs compare favorably with equivalent services
    provided by an outside source).

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-   appropriateness of the qualifications of staff.

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-   appropriateness of the budget request in relation to the amount and
    quality of the service provided.

-   for high throughput shared resources, breadth of use by, and benefit
    to, center members; for low throughput or specialized shared
    resources, benefit to members and accessibility based on a fair and
    equitable prioritization system.

-   where relevant, extent of compliance with NCI, national or
    international standards.

-   if an institutional shared resource

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-   adequacy of CCSG member access to the facility's services.

-   benefits center members receive as a result of CCSG support.

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-   participation of the center in facility planning and oversight.

    -   for consortium centers, adequacy of mechanisms in place to
        ensure that all members have appropriate access to shared
        resources .

**Protocol Review and Monitoring System (PRMS) -- Guidelines Section
Part II, 9.2 (approve, conditionally approve or disapprove)**

-   appropriateness of the composition of the committee and the
    qualifications of its members, for ensuring sufficient size and
    breadth of expertise to conduct a critical, fair scientific review
    of all clinical research protocols involving cancer patients in the
    institution or institutions comprising the center.

-   authority and process for initiating, monitoring and terminating all
    cancer clinical research protocols in the institution or
    institutions comprising the center.

-   appropriateness of criteria and process for scientific review,
    taking into account the specific rationale, study design,
    duplication of studies already in progress elsewhere, adequacy of
    biostatistical input, and feasibility for completion within a
    reasonable time frame.

-   appropriateness of mechanisms for overseeing the prioritization of
    competing protocols from all sources (including cooperative group
    trials and industry trials) and thus, for ensuring optimal use of a
    center's clinical resources for scientific purposes.

-   adequacy of criteria and process for monitoring trials to ensure
    ongoing research is making sufficient scientific progress, including
    adequate patient accrual rates, and for terminating trials that do
    not meet scientific goals.

-   for consortium centers, a single Protocol Review and Monitoring
    System governing all cancer clinical trial protocols across all the
    partner institutions.

**Protocol Specific Research Support -- Guidelines Section Part II, 9.3
(merit descriptor)**

-   proposed studies comply with criteria for support, as outlined in
    Part II, Section 9.3

-   scientific quality and innovation of proposed studies

-   appropriateness of the number and percent effort of research nurses
    and data managers involved in the direct conduct of *institutional,
    investigator-initiated,* feasibility (pilot or pre-phase I) or phase
    I studies that are not funded via other peer reviewed mechanisms.

-   adequacy of the process for setting priorities in the assignment of
    these research nurses and/or data managers and for overseeing the
    progress of the research.

**Data and Safety Monitoring Plan -- Guidelines Section 12 (acceptable,
unacceptable)**

-   general adequacy of the Plan itself in defining the general
    structure of the monitoring entity and mechanisms for reporting
    adverse events.

-   for centers requesting funds for implementation of DSM functions
    (Note that budgets for DSM functions must be presented and justified
    separately from other components):

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-   general adequacy of DSM functions for the different kinds of studies
    (e.g., therapeutic trial, behavioral intervention, gene therapy
    trials that require evaluation, auditing, and monitoring) - NOT the
    specific evaluation of any particular study or the audit of that
    study.

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-   adequacy of the expertise of individuals serving on key committees
    that perform DSM functions.

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-   for consortium centers, a single Data and Safety Monitoring Plan
    governing all cancer clinical trial protocols across partner
    institutions.

**Minority and Gender Representation -- Guidelines Section Part II, 10
(approval, disapproval)**

-   appropriateness of the accrual of women and minorities to both
    therapeutic and non-therapeutic clinical trials in proportion to the
    center's catchment area based on demographic and accrual data
    provided

-   when accrual is inadequate, adequacy of the center's plan to improve
    performance

**Inclusion of Children in Clinical Trials-Guidelines Section Part II,
11 (acceptable or unacceptable)**

-   appropriateness of the plan for including children in clinical
    trials or acceptability of the justification for exclusion of
    children in clinical trials

**Overall Merit Rating of the Cancer Center (merit descriptor)**

-   overall quality of the cancer-relevant science

-   overall strength of the other components of the application

-   extent of value added by the CCSG to the center

**Duration - Guidelines Section Part I, Budget and Funding Policies**

-   recommended number of years of support

**Overall Budget Recommendation:**

If after evaluating all individual budget requests, the total budget
seems excessive relative to the overall quality of the cancer focused
science in the center, or in relationship to their NCI funding base,
reviewers may recommend a single cut in the overall budget without
identifying specific areas for reduction.

**Criteria for Comprehensiveness -- Guidelines Section Part II, 16
(approval/disapproval)**

-   **Stage I, Scientific Elements**

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-   adequacy of the depth, and breadth in *each* of the three major
    areas of laboratory, clinical, and prevention, control and
    population sciences.

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-   evidence of strong transdisciplinary research bridging these
    sciences.

Note: Comprehensiveness for centers proposing consortia or affiliations
may be based on research in the applicant institution or on supplemental
strengths of all collaborating institutions.

-   **Stage II, Education and Training of Biomedical Researchers and
    Health Care Professionals**

    -   training of basic, clinical, and prevention and control cancer
        researchers as evidenced by a list of competitive training
        grants awarded to center investigators.

    -   recruitment of under-represented minorities and special
        populations to research training programs as evidenced by data
        on total trainees and minority trainees and a narrative
        discussion of recruitment accomplishments and hurdles.

    -   continuing education and training of health care professionals,
        in a spectrum of state-of-the-art cancer care and services, with
        a particular focus on prevention and on accrual of patients to
        cancer clinical trials, as evidenced by a list of training
        activities, seminars, and continuing education opportunities.

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-   **Stage II, Community Service, Outreach and Dissemination**

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-   the knowledge of the cancer problem in the community served by the
    center, as evidenced by demographic data, narrative discussion of
    special or underserved populations and pertinent cancer incidence
    and mortality data.

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-   process for priority setting and use of available expertise and
    resources to serve the community in ways that will reduce cancer
    incidence and mortality.

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-   outreach activities, including those that address the special
    problems of the community, as evidenced by a listing and discussion
    of such activities and any other supporting documentation

    -   collaborations with not for profit or for profit outreach
        programs; and with other centers, community hospitals, and
        private oncology practices when service regions are overlapping,
        to develop complementary outreach efforts to maximally benefit
        the community, as evidenced by a listing and discussion of such
        collaborative efforts.

    -   process for evaluation of the impact of outreach and
        dissemination activities on clinical and public health systems
        within the center's catchment area.

**This document can be viewed or downloaded online at
<http://cancercenters.cancer.gov/>**

[^1]: Definition of Transdisciplinary Research: Collaborations in which
    exchanging information, altering discipline-specific approaches,
    sharing resources, and integrating different disciplines achieves a
    common scientific goal. The term 'trans-disciplinary' refers to
    integrated (not specific to a discipline) research methods,
    conceptual development, multiple levels of analysis, and science
    that produces new models and understanding exceeding the sum of the
    parts.