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<col style="width: 6%" />
<col style="width: 1%" />
<col style="width: 18%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="12"><p>Operations and Informatics Branch</p>
<p>Protocol and Information Office</p>
<p>Cancer Therapy Evaluation Program, DCTD, NCI</p>
<p>6130 Executive Blvd., Rm. 7000, Executive Plaza North</p>
<p>Rockville, MD 20852</p>
<p>Phone: 301-496-1367</p>
<p><strong>E-mail: <a
href="mailto:pio@ctep.nci.nih.gov">pio@ctep.nci.nih.gov</a></strong></p></td>
<td colspan="19">CTEP Protocol Submission Worksheet v4.4</td>
</tr>
<tr class="even">
<td colspan="31"><h6
id="complete-all-relevant-sections.-submit-protocol-and-informed-consent-electronically-to-pioctep.nci.nih.gov.">Complete
all relevant sections. Submit protocol and informed consent
electronically to pio@ctep.nci.nih.gov. </h6>
<p><strong>SECTION 1: GENERAL INFORMATION</strong> <em><strong>Required
for ALL protocols</strong></em></p></td>
</tr>
<tr class="odd">
<td colspan="31"><ol type="A">
<li><p><strong>Overview of Protocol Information:</strong></p></li>
</ol></td>
</tr>
<tr class="even">
<td colspan="7">Organization (local) Protocol No.:</td>
<td colspan="8"></td>
<td colspan="16"></td>
</tr>
<tr class="odd">
<td>Protocol Title:</td>
<td colspan="30"></td>
</tr>
<tr class="even">
<td colspan="31"></td>
</tr>
<tr class="odd">
<td colspan="5">Name of Lead Organization:</td>
<td colspan="21"></td>
<td colspan="4">NCI Institution Code:<sup>1</sup></td>
<td></td>
</tr>
<tr class="even">
<td colspan="5"></td>
<td colspan="26"><em>(e.g., Group, Consortium, Institution)</em></td>
</tr>
<tr class="odd">
<td colspan="11">Principal Investigator (PI)/ Study Chairperson
Name:</td>
<td colspan="14"></td>
<td colspan="5">NCI Investigator No.:<sup>2</sup></td>
<td></td>
</tr>
<tr class="even">
<td>PI Phone No.:</td>
<td colspan="8">( )</td>
<td colspan="4">PI Fax No.:</td>
<td colspan="10">( )</td>
<td colspan="5">PI E-mail Address:</td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="2">PI Mailing Address:</td>
<td colspan="29"></td>
</tr>
<tr class="even">
<td colspan="31"><em><strong>Principal Investigator (PI)</strong> - The
individual ultimately responsible for monitoring the progress of the
clinical trial.  Responsibilities include registration of all
participating investigators, monitoring the scientific integrity of the
trial, overseeing all submissions to the sponsor, compliance with
regulatory affairs, keeping CTEP comprised of the trial status, and
analyzing and publishing study results. <strong>Study
Chairperson</strong> – The common name for Principal Investigators in
Cooperative Group trials.</em></td>
</tr>
<tr class="odd">
<td colspan="3">Study Coordinator Name:</td>
<td colspan="17"></td>
<td></td>
<td colspan="6">Study Coordinator Phone No.:</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td colspan="8">Study Coordinator Email Address:</td>
<td colspan="12"></td>
<td></td>
<td colspan="6">Study Coordinator Fax No.:</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td colspan="31">Is this a multicenter (Non-Cooperative Group) study?
yes no If yes, refer to the Multicenter Trials guidelines in Section
7.2.15 of the Investigator Handbook or at <a
href="http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_multicenter.htm">http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_multicenter.htm</a>,
for further instructions.</td>
</tr>
<tr class="even">
<td colspan="31">Is CCOP credit requested? yes no</td>
</tr>
<tr class="odd">
<td colspan="24">Study Phase (check one): 0 1 1/2 1/3 2 2/3 3 Pilot
Other, specify:</td>
<td colspan="7"></td>
</tr>
<tr class="even">
<td colspan="31">Does this study have a blinded component to it? yes
no</td>
</tr>
<tr class="odd">
<td colspan="31">Have you submitted a <strong>LETTER of INTENT</strong>
for this study? yes no <em><strong>OR</strong></em> Have you submitted a
<strong>CONCEPT</strong> for this study? yes no</td>
</tr>
<tr class="even">
<td colspan="10">If yes, provide the <strong>NCI LOI/Concept
Number</strong>:</td>
<td colspan="7"></td>
<td colspan="14"></td>
</tr>
<tr class="odd">
<td colspan="31"><ol start="2" type="A">
<li><p><strong>Funding Information:</strong></p></li>
</ol></td>
</tr>
<tr class="even">
<td colspan="31">Is or will this study be funded by a Grant or
Cooperative Agreement? yes no pending</td>
</tr>
<tr class="odd">
<td colspan="19">If yes or pending, provide the <strong>Grant</strong>
or <strong>Cooperative Agreement Number</strong>:</td>
<td colspan="12"></td>
</tr>
<tr class="even">
<td colspan="16"></td>
<td colspan="15"><em>(Grant and Cooperative Agreement Number example:
U01 CA 12345; Do not cite P30 Cancer Center Support/Grant)</em></td>
</tr>
<tr class="odd">
<td colspan="31">Is this study funded by an NIH Contract? yes no
pending</td>
</tr>
<tr class="even">
<td colspan="18">If yes, provide the <strong>Contract
Number</strong><em>(Contract Number example: N01 CM 12345)</em>:</td>
<td colspan="13"></td>
</tr>
<tr class="odd">
<td colspan="31">Are you receiving support from non-NCI/non-NIH sources
(i.e., Institutional Funds, Industry, ACS) for this study? yes no</td>
</tr>
<tr class="even">
<td colspan="4">If yes, specify the source:</td>
<td colspan="27"></td>
</tr>
<tr class="odd">
<td colspan="22"><blockquote>
<p>NCI Sponsor (i.e., provides IND/Funding): CTEP DCP CIP Other
(Specify):</p>
</blockquote></td>
<td colspan="9"></td>
</tr>
<tr class="even">
<td colspan="31"><ol start="3" type="A">
<li><p><strong>Study Objectives:</strong></p></li>
</ol></td>
</tr>
<tr class="odd">
<td colspan="31">Will inpatient therapy be required for the
investigational portion of this study? yes no</td>
</tr>
<tr class="even">
<td colspan="31"><em>(Inpatient therapy - &gt;24hrs in a medical
facility for investigational intervention. Answer ‘No’ if inpatient
therapy is only required as part of the standard therapy portion of the
study.)</em></td>
</tr>
<tr class="odd">
<td colspan="31"><strong>Specify the Study Type to be used to address
the <u>PRIMARY OBJECTIVE</u> of the study (check one):</strong></td>
</tr>
<tr class="even">
<td colspan="6">Treatment</td>
<td colspan="8">Economic</td>
<td colspan="9">Epidemiology</td>
<td colspan="6">Imaging</td>
<td colspan="2">Laboratory Correlation</td>
</tr>
<tr class="odd">
<td colspan="6">Quality of Life</td>
<td colspan="8">Registry</td>
<td colspan="9">Supportive Care</td>
<td colspan="6">Symptom Amelioration</td>
<td colspan="2">Tissue Banking</td>
</tr>
<tr class="even">
<td colspan="6">Cancer Control</td>
<td colspan="8">Prevention</td>
<td colspan="9">If <strong>Prevention</strong>, please specify:</td>
<td colspan="6">Primary Malignancy</td>
<td colspan="2">Secondary Malignancy</td>
</tr>
<tr class="odd">
<td colspan="31"><p><em>Definitions: Treatment - An intervention to
reduce the morbidity and mortality of cancer. The focus of the
intervention is the primary cancer diagnosis.</em></p>
<p><em>Cancer Control - intervention to reduce the morbidity and
complications of cancer or its treatment focusing on supportive care,
not the primary cancer diagnosis.</em></p>
<p><em>Prevention - An intervention to reduce the risk of developing
cancer.</em></p></td>
</tr>
<tr class="even">
<td colspan="31"><strong>Specify the Study Type to be used to address
the <u>SECONDARY OBJECTIVES</u> of the study (check all that
apply):</strong></td>
</tr>
<tr class="odd">
<td colspan="6">Treatment</td>
<td colspan="8">Economic</td>
<td colspan="9">Epidemiology</td>
<td colspan="6">Imaging</td>
<td colspan="2">Laboratory Correlation</td>
</tr>
<tr class="even">
<td colspan="6">Quality of Life</td>
<td colspan="8">Registry</td>
<td colspan="9">Supportive Care</td>
<td colspan="6">Symptom Amelioration</td>
<td colspan="2">Tissue Banking</td>
</tr>
<tr class="odd">
<td colspan="6">Cancer Control</td>
<td colspan="8">Prevention</td>
<td colspan="9">If <strong>Prevention</strong>, please specify:</td>
<td colspan="6">Primary Malignancy</td>
<td colspan="2">Secondary Malignancy</td>
</tr>
</tbody>
</table>

<table style="width:100%;">
<colgroup>
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 7%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 0%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 6%" />
<col style="width: 7%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 8%" />
<col style="width: 2%" />
<col style="width: 2%" />
<col style="width: 8%" />
<col style="width: 0%" />
<col style="width: 0%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td colspan="33"><ol start="4" type="A">
<li><p><strong>Specify the Agent(s) to be used in this
Study:*</strong></p></li>
</ol></td>
</tr>
<tr class="even">
<td></td>
<td colspan="7" rowspan="2"><strong>Agent<br />
Name</strong></td>
<td colspan="6" rowspan="2"><strong>Request for<br />
CTEP/PMB<br />
distribution?</strong></td>
<td colspan="3" rowspan="2"><strong>Is the agent
Investigational?</strong></td>
<td colspan="4" rowspan="2"><strong>IND<br />
Number</strong></td>
<td colspan="3" rowspan="2"><strong>IND<br />
Holder</strong></td>
<td colspan="4" rowspan="2"><strong>IND<br />
Sponsor</strong></td>
<td colspan="3"><strong>NSC No.<sup>1</sup></strong></td>
<td colspan="3" rowspan="2"><strong>Placebo Controlled?</strong></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"><em>(NSC Numbers must be provided if agent is
Investigational)</em></td>
</tr>
<tr class="even">
<td></td>
<td colspan="7"></td>
<td colspan="6">yes no</td>
<td colspan="3">yes no</td>
<td colspan="4"></td>
<td colspan="3"><p>CTEP Site</p>
<p>Investigator</p>
<p>Company</p>
<p>Other (Specify):</p></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="3">yes no</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="7"></td>
<td colspan="6">yes no</td>
<td colspan="3">yes no</td>
<td colspan="4"></td>
<td colspan="3"><p>CTEP Site</p>
<p>Investigator</p>
<p>Company</p>
<p>Other (Specify):</p></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="3">yes no</td>
</tr>
<tr class="even">
<td></td>
<td colspan="7"></td>
<td colspan="6">yes no</td>
<td colspan="3">yes no</td>
<td colspan="4"></td>
<td colspan="3"><p>CTEP Site</p>
<p>Investigator</p>
<p>Company</p>
<p>Other (Specify):</p></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="3">yes no</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="7"></td>
<td colspan="6">yes no</td>
<td colspan="3">yes no</td>
<td colspan="4"></td>
<td colspan="3"><p>CTEP Site</p>
<p>Investigator</p>
<p>Company</p>
<p>Other (Specify):</p></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="3">yes no</td>
</tr>
<tr class="even">
<td></td>
<td colspan="7"></td>
<td colspan="6">yes no</td>
<td colspan="3">yes no</td>
<td colspan="4"></td>
<td colspan="3"><p>CTEP Site</p>
<p>Investigator</p>
<p>Company</p>
<p>Other (Specify):</p></td>
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="3">yes no</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33"><em>* For treatment studies, include only anti-cancer
agents. If additional space is required, please include as an
attachment.</em></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><ol start="5" type="A">
<li><p><strong>Specify the type(s) of Therapy(ies) to be used in this
study (<em>check all that apply</em>):</strong></p></li>
</ol></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="7">Drug and/or Immunotherapy</td>
<td colspan="9">Gene Transfer</td>
<td colspan="4">Image Directed<br />
Local Therapy</td>
<td colspan="3">Radiation Therapy</td>
<td colspan="5">Hematopoietic Stem Cell Transplantation</td>
<td colspan="4">Surgery</td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><ol start="6" type="A">
<li><p><strong>Study Disease:</strong></p></li>
</ol></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="14">Phase 1 Studies (<em>check one below</em>):</td>
<td></td>
<td colspan="18">Phase 2, 3, and Disease-specific Phase 1 studies
(<em>specify the Name and Code of the Study Disease below</em>):</td>
</tr>
<tr class="even">
<td></td>
<td colspan="14">Disease-Specific</td>
<td></td>
<td colspan="11">Disease Name<strong><sup>1</sup></strong></td>
<td colspan="7">Disease Code<strong><sup>1</sup></strong></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="14">Hematologic Malignancy (NOS)</td>
<td></td>
<td colspan="11"></td>
<td colspan="7"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="14">Solid Tumor (NOS)</td>
<td></td>
<td colspan="11"></td>
<td colspan="7"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="14"></td>
<td></td>
<td colspan="11"></td>
<td colspan="7"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><ol start="7" type="A">
<li><p><strong>Study Age Population (specify in
years):</strong></p></li>
</ol></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="6">Lower Age Limit:</td>
<td colspan="6"></td>
<td colspan="6"><blockquote>
<p>Upper Age Limit:</p>
</blockquote></td>
<td></td>
<td colspan="14"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><sup>1</sup> See <a
href="http://ctep.cancer.gov/protocolDevelopment/codes_values.htm">http://ctep.cancer.gov/protocolDevelopment/codes_values.htm</a>
for a complete list of Organization (Group, Consortium and Institution),
IND and NSC Numbers, and Disease Names and Codes.</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33"><strong>SECTION 2: EMBEDDED CORRELATIVE STUDIES
<em>Required for ALL Treatment Studies (if
applicable)</em></strong></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><p>An Embedded Correlative Study is a trial that is
incorporated into a larger trial. The embedded study is included as a
sub-trial or secondary end-point of the larger trial (i.e., obtaining
pharmacokinetics during a treatment trial). The primary objective of
collecting a description of embedded correlative studies is to document
and recognize the important contributions to basic science that
investigators are performing within a larger trial. This information may
be utilized as a resource to improve collaboration between investigators
and as a potential aid to improve funding of the NCI and its
collaborators.</p>
<p>A brief description of all correlative studies embedded in this trial
must be provided in the space below. The description of all correlative
studies must have enough information to determine what the purpose of
the study is. The same business rules that apply to writing the title of
the primary trial should be employed. For example, “EGFR testing” is
insufficient. A more appropriate title would be “EGFR testing and gene
expression analysis (ERCC-1, EGF-R, XPD, VEGF, COX-2, XRCC-1, and
GST-P1) on paraffin embedded tissue using laser capture microdissection
and PCR.”</p>
<p><strong>Correlative Study Identification Code</strong>: Each
correlative study should have a unique identification code. Please
provide a unique code for each correlative study. Correlative study
codes should be limited to a maximum of 10 characters (alpha and/or
numeric). Example Correlative Study Identification Code: P-123.</p></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33">Does this study include an embedded correlative
study(ies)? yes no If yes, complete the following.</td>
</tr>
<tr class="even">
<td></td>
<td colspan="2"></td>
<td colspan="7"><strong>Correlative Study Identification
Code</strong></td>
<td colspan="13"><blockquote>
<p><strong>Title</strong></p>
</blockquote></td>
<td colspan="3"><strong>Correlative Grant Number<br />
</strong>(<em>if different from Treatment Grant Number</em>)</td>
<td colspan="3"><blockquote>
<p><strong>Anticipated Number of Samples Analyzed</strong></p>
</blockquote></td>
<td colspan="5"><blockquote>
<p><strong>Estimated Cost/Sample Analyzed</strong></p>
</blockquote></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">1.</td>
<td colspan="7"></td>
<td colspan="13"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="5"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2">2.</td>
<td colspan="7"></td>
<td colspan="13"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="5"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">3.</td>
<td colspan="7"></td>
<td colspan="13"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="5"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2">4.</td>
<td colspan="7"></td>
<td colspan="13"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="5"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">5.</td>
<td colspan="7"></td>
<td colspan="13"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="5"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><em>If additional space is required, please include as
an attachment.</em></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33"><h1
id="section-3-subgroup-code-information-the-information-requested-in-this-section-is-optional">SECTION
3: SUBGROUP CODE INFORMATION <em>The information requested in this
section is OPTIONAL</em></h1></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><p>A subgroup (stratum) code is a unique patient
characteristic that will be utilized to uniformly group patients for
separate analysis or treatment. Please provide the following Subgroup
Identification Code(s) and Subgroup Description(s), if subgroups are
specified in the protocol.</p>
<p><strong>Subgroup Identification Code</strong>: Each subgroup should
have a unique identification code. Please provide a code for each
subgroup. Subgroup codes should be limited to a maximum of 10 characters
(alpha and/or numeric). If a study has only a single subgroup then all
patients will be entered on subgroup “SG1”.</p>
<p><strong>Subgroup Description</strong>: Patients are stratified by
either disease or other classification (example: prior therapy, age). If
by disease, indicate what disease(s) will be included in each subgroup.
Use Medical Dictionary for Regulatory Activities (MedDRA) codes. Please
see the <em>List of Codes and Values</em> from the CTEP home page for a
comprehensive list of MedDRA terms and codes. If by classification other
than disease, describe what patient characteristics will be used to
uniformly group patients for treatment or analysis. <em>Example Subgroup
Description: Patients with previously untreated gliomas.</em></p></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"><h4 id="section"></h4></td>
<td colspan="7"><h4 id="subgroup-identification-code">Subgroup
Identification Code</h4></td>
<td colspan="23"><h4 id="description">Description</h4></td>
</tr>
<tr class="even">
<td></td>
<td colspan="3">1<em>.</em></td>
<td colspan="7"></td>
<td colspan="23"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3">2.</td>
<td colspan="7"></td>
<td colspan="23"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="3">3.</td>
<td colspan="7"></td>
<td colspan="23"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3">4.</td>
<td colspan="7"></td>
<td colspan="23"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="3">5.</td>
<td colspan="7"></td>
<td colspan="23"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33"><em>If additional space is required, please include as
an attachment.</em></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><h1
id="section-4-treatment-assignment-code-information-the-information-requested-in-this-section-is-optional">SECTION
4: TREATMENT ASSIGNMENT CODE INFORMATION <em>The information requested
in this section is OPTIONAL</em> </h1></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="33">Please see the Treatment Assignment Instructions and
Guidelines available from the CTEP home page for a complete description
of Treatment Assignment Code (TAC) and Treatment Assignment Description
(TAD) requirements. Include agent name, dose, route, duration, and
schedule (i.e., Cisplatin 100mg/m2 IV over 1 hour on Day 1, every 21
days and Taxol 130mg/m2 IV over 3 hours on Day 1, every 21 days).</td>
</tr>
<tr class="even">
<td></td>
<td colspan="4"></td>
<td colspan="7"><strong>Treatment Assignment Code</strong></td>
<td colspan="22"><h2 id="description-1">Description</h2></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">1.</td>
<td colspan="7"></td>
<td colspan="22"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">2.</td>
<td colspan="7"></td>
<td colspan="22"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">3.</td>
<td colspan="7"></td>
<td colspan="22"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">4.</td>
<td colspan="7"></td>
<td colspan="22"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">5.</td>
<td colspan="7"></td>
<td colspan="22"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="33"><em>If additional space is required, please include as
an attachment.</em></td>
</tr>
<tr class="odd">
<td colspan="33"><strong>SECTION 5: GENDER AND MINORITY ACCRUAL
ESTIMATES</strong> <em><strong>Required for ALL Phase 2, Phase 3, and
Pilot studies</strong></em></td>
<td></td>
</tr>
<tr class="even">
<td colspan="33"><p>In accordance with the NIH guidelines on the
inclusion of women and minorities as subjects in clinical research, the
Department of Health and Human Services (HHS) requires that all Phase 2
and 3 trials must include accrual targets for males, females and
minorities. The accrual targets should reflect the expected accrual over
the life of the study.</p>
<p>The policy states that women and members of minority groups and their
sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear
and compelling rational and justification establishes inclusion is
inappropriate with respect to the health of the subjects or the purpose
of the research. The NCI suggests that the accrual targets be based on
data from similar trials completed by your organization during the
previous five years. It is hoped that the accrual targets will resemble
the gender, ethnic and racial composition of the U.S. population as
closely as possible. Please see the <strong>Ethnic and Racial
Categories</strong> listed below for a complete description of ethnic
and racial categories.</p></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="6"><strong>Ethnic Categories:</strong></td>
<td colspan="26"><p><strong>Hispanic or Latino –</strong> a person of
Cuban, Mexican, Puerto Rico, South or Central American, or other Spanish
culture or origin, regardless of race. The term “Spanish origin” can
also be used in addition to “Hispanic or Latino.”</p>
<h4 id="not-hispanic-or-latino">Not Hispanic or Latino</h4></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="6"><strong>Racial Categories:</strong></td>
<td colspan="26"><p><strong>American Indian or Alaskan Native –</strong>
a person having origins in any of the original peoples of North,
Central, or South America, and who maintains tribal affiliations or
community attachment.</p>
<p><strong>Asian –</strong> a person having origins in any of the
original peoples of the Far East, Southeast Asia, or the Indian
subcontinent including, for example, Cambodia, China, India, Japan,
Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and
Vietnam. (Note: Individuals from the Philippine Islands have been
recorded as Pacific Islanders in previous data collection
strategies.)</p>
<p><strong>Black or African American –</strong> a person having origins
in any of the black racial groups of Africa. Terms such as “Haitian” or
“Negro” can be used in addition to “Black or African American.”</p>
<p><strong>Native Hawaiian or other Pacific Islander –</strong> a person
having origins in any of the original peoples of Hawaii, Guam, Samoa, or
other Pacific Islands.</p>
<p><strong>White –</strong> a person having origins in any of the
original peoples of Europe, the Middle East, or North Africa.</p></td>
<td colspan="2"></td>
</tr>
</tbody>
</table>

+--------------------------+------------+---+------------+---+-------------+
| ## EXAMPLE               |            |   |            |   |             |
|                          |            |   |            |   |             |
| ## Accrual Targets       |            |   |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| **Ethnic Category**      | **Se       |   |            |   |             |
|                          | x/Gender** |   |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
|                          | *          |   | **Males**  |   | **Total**   |
|                          | *Females** |   |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| Hispanic or Latino       | 20         | \ | 10         | = | 30          |
|                          |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| Not Hispanic or Latino   | 40         | \ | 30         | = | 70          |
|                          |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| **Ethnic Category: Total | 60 (A1)    | \ | 40 (B1)    | = | 100 (C1)    |
| of all subjects**        |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| **Racial Category**      |            |   |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| American Indian or       | 1          | \ | 0          | = | 1           |
| Alaskan Native           |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| Asian                    | 1          | \ | 1          | = | 2           |
|                          |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| Black or African         | 1          | \ | 0          | = | 1           |
| American                 |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| Native Hawaiian or other | 7          | \ | 9          | = | 16          |
| Pacific Islander         |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| White                    | 50         | \ | 30         | = | 80          |
|                          |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
| **Racial Category: Total | 60 (A2)    | \ | 40 (B2)    | = | 100 (C2)    |
| of all subjects**        |            | + |            |   |             |
+--------------------------+------------+---+------------+---+-------------+
|                          | (A1 = A2)  |   | (B1 = B2)  |   | (C1 = C2)   |
+--------------------------+------------+---+------------+---+-------------+

***Enter actual estimates, whole numbers only (percentages, fractions,
or decimals are not acceptable).***

The totals provided for each Ethnic/gender or Ethnic/total combination
must match those given for each Race/gender or Race/total combination
(i.e., A1 must match A2, B1 must match B2, and C1 must match C2).

<table style="width:100%;">
<colgroup>
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 3%" />
<col style="width: 12%" />
<col style="width: 12%" />
<col style="width: 7%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 6%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 20%" />
<col style="width: 0%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td colspan="15"><h2 id="accrual-targets-1">Accrual Targets</h2></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4" rowspan="2"><strong>Ethnic Category</strong></td>
<td colspan="11"><strong>Sex/Gender</strong></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2"><strong>Females</strong></td>
<td colspan="2"></td>
<td colspan="4"><strong>Males</strong></td>
<td></td>
<td colspan="2"><strong>Total</strong></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">Hispanic or Latino</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">Not Hispanic or Latino</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4"><strong>Ethnic Category: Total of all
subjects</strong></td>
<td colspan="2">(A1)</td>
<td colspan="2">+</td>
<td colspan="4">(B1)</td>
<td>=</td>
<td colspan="2">(C1)</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4"><strong>Racial Category</strong></td>
<td colspan="11"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">American Indian or Alaskan Native</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">Asian</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">Black or African American</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">Native Hawaiian or other Pacific Islander</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">White</td>
<td colspan="2"></td>
<td colspan="2">+</td>
<td colspan="4"></td>
<td>=</td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4"><strong>Racial Category: Total of all
subjects</strong></td>
<td colspan="2">(A2)</td>
<td colspan="2">+</td>
<td colspan="4">(B2)</td>
<td>=</td>
<td colspan="2">(C2)</td>
</tr>
<tr class="even">
<td></td>
<td colspan="4"></td>
<td colspan="2">(A1 = A2)</td>
<td colspan="2"></td>
<td colspan="4">(B1 = B2)</td>
<td></td>
<td colspan="2">(C1 = C2)</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="15"></td>
</tr>
<tr class="even">
<td></td>
<td><strong>Accrual Rate:</strong></td>
<td colspan="2"></td>
<td>pts/month</td>
<td colspan="3"><strong>Total Expected Accrual:</strong></td>
<td colspan="2"></td>
<td>Min</td>
<td></td>
<td colspan="4">Max</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">Projected Start Date of Study:</td>
<td colspan="2"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td></td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td colspan="15"><strong>SECTION 6: COMMON DATA ELEMENTS (CDE)
<em>Required for Cooperative Group Phase 3 Studies in the following
diseases: gastrointestinal (pancreatic, gastric, esophageal and
colorectal), genitourinary (bladder and prostate), gynecological
(ovarian, endometrial and cervical), breast, lung (small cell and
non-small cell), leukemia (MDS, acute and chronic), and
melanoma</em></strong></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="15"><p>CDE Dictionary is available from the CTEP home page
(http://ctep.cancer.gov).</p>
<p>Submission of Case Report Forms Using Common Data Elements: It is
strongly recommended that Case Report Forms (CRFs) be submitted with the
original protocol submission. If necessary, CRFs may be submitted at a
later date to allow for scientific review of the protocol document,
which may have an impact on data points in the CRFs. However, CTEP will
not approve a protocol until the CDE compliance review is completed and
the CRFs are approved by CTEP.</p>
<p>The CRF CDE Compliance Review Committee will provide the Cooperative
Groups with an evaluation of CDE usage and, if necessary, a
protocol-specific spreadsheet of new terms determined during review.
After receiving the CRF CDE Compliance Review, the Groups will revise
the CRFs in accordance with the Committee's recommendations and return
them along with the spreadsheet of new terms. The Group may also provide
alternative CDE terms along with strong justification for their use.
Completed attributes must be included for each new term that will be
used on the CRFs.</p></td>
<td></td>
</tr>
</tbody>
</table>

+-----------------------------------------------------------------------+
| **SECTION 7: TRIAL COMPLEXITY ELEMENTS *Required for ALL Phase 3      |
| Treatment Studies*.**                                                 |
|                                                                       |
| In accordance with the CTWG recommendations, all phase 3 treatment    |
| studies will be evaluated for complexity of the work needed to be     |
| done by sites implementing these trials. Additional capitation        |
| payments may be available for select highly complex trials depending  |
| on available funds. Trial Complexity supplements will be determined   |
| on an annual basis.                                                   |
|                                                                       |
| Please enter a score for each trial complexity tier element in the    |
| chart below using the scoring system of 0 for standard complexity     |
| element, 1 for moderate complexity, 2 for high complexity. To         |
| determine scores, please use the Trial Complexity Elements & Scoring  |
| sheet, which includes the element names, descriptions, and scoring    |
| examples located on the CTEP web site at:                             |
| [<http://ctep.cancer.gov/protoco                                      |
| lDevelopment/docs/trial_complexity_elements_scoring.doc>]{.underline} |
+-----------------------------------------------------------------------+
|   -----                                                               |
| ------ ----------- ----------- ----------- ----------- ----------- -- |
| --------- ----------- ----------- ----------- ----------- ----------- |
|                                                                       |
|          **Element   **Element   **Element   **Element   **Element    |
| **Element   **Element   **Element   **Element   **Element   **TOTAL** |
|               1**         2**         3**         4**         5**     |
|          6**         7**         8**         9**         10**         |
|                                                                       |
|   **Score**                                                           |
|                                                                       |
|   -----                                                               |
| ------ ----------- ----------- ----------- ----------- ----------- -- |
| --------- ----------- ----------- ----------- ----------- ----------- |
|                                                                       |
| Additional comments on trial complexity:                              |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                      |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                                                                       |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\                                         |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
|                                                                       |
| **SECTION 8: PERSON COMPLETING WORKSHEET** ***Provide the following   |
| information***                                                        |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| ***Print Name Phone No. E-mail Address***                             |
+-----------------------------------------------------------------------+
| ***Signature** (not required for electronic submissions) **Date***    |
+-----------------------------------------------------------------------+