PREFACE

*This document is the DMID protocol template, which is required for
DMID-sponsored clinical studies that pose only minimal risk to study
subjects. Minimal risk is defined by 45 U.S. Code of Federal Regulations
(CFR) 46.102 (i) as follows:*

> *"Minimal risk means that the probability and magnitude of harm or
> discomfort anticipated in the research are not greater in and of
> themselves than those ordinarily encountered in daily life or during
> the performance of routine physical or psychological examinations or
> tests."*

*Refer to:
<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102>*

*Categories of research that are minimal risk are defined by OHRP
guidelines. Refer to:
<http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm>*

*Note that instructions and explanatory text are indicated by italics
and should be replaced in your protocol document with appropriate
protocol-specific text. Section headings and template text formatted in
regular type should be included in your protocol document as provided in
the template.*

*The Principal Investigator (PI) must attach all explanatory and
appended materials (including, but not limited to, surveys, consent
forms, interview scripts, and recruitment flyers/brochures) referred to
in the protocol.*

*Refer questions regarding use of this protocol template to the
appropriate DMID Protocol Champion or Clinical Affairs Specialist.*

**TITLE**

**\*DMID Protocol Number:**

*\*(Protocol number required -- Protocol Champion must complete attached
form)*

**Sponsored by:**

National Institute of Allergy and Infectious Diseases (NIAID)

**DMID Funding Mechanism:**

**Principal Investigator:**

**\*DMID Protocol Champion:**

*\*(Protocol Champion must complete attached form to generate Protocol
Number)*

**Draft or Version Number:** *(see DMID SOP for assigning version #s)*

**Day Month Year**

*(Write out the month and use international date format, e.g., 23
January 2004)*

***[This template is adapted from the ICH guidance document E6 (Good
Clinical Practices), Section 6.]{.mark}***

Statement of Compliance

*Provide a statement that the clinical study will be conducted in
compliance with the protocol, GCP and the applicable regulatory
requirements. An example is provided below:*

*The study will be carried out in accordance with Good Clinical Practice
(GCP) as required by the following \[use applicable regulations
depending on study location and sponsor requirements; samples follow\]:*

-   *U.S. Code of Federal Regulations applicable to clinical studies (45
    CFR 46)*

-   *ICH GCP E6*

-   *Completion of Human Subjects Protection Training*

-   *NIH Clinical Terms of Award*

*Refer to:
<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46>.*

[*http://www.fda.gov/cder/guidance/959fnl.pdf*](http://www.fda.gov/cder/guidance/959fnl.pdf)

*http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html*

> *http://cme.cancer.gov/c01/*

SIGNATURE PAGE

The signature below constitutes the approval of this protocol and the
attachments, and provides the necessary assurances that this trial will
be conducted according to all stipulations of the protocol, including
all statements regarding confidentiality, and according to local legal
and regulatory requirements and applicable US federal regulations and
ICH guidelines.

+------+-----------------------------------------+-----+--------------+
| Site |                                         |     |              |
| Inv  |                                         |     |              |
| esti |                                         |     |              |
| gato |                                         |     |              |
| r:\* |                                         |     |              |
+------+-----------------------------------------+-----+--------------+
| Sig  |                                         | Da  |              |
| ned: |                                         | te: |              |
+------+-----------------------------------------+-----+--------------+
|      | *Name*                                  |     |              |
|      |                                         |     |              |
|      | *Title*                                 |     |              |
+------+-----------------------------------------+-----+--------------+

*\* The protocol should be signed by the local investigator who is
responsible for the study implementation at his/her specific site; ie,
if Investigational New Drug study, the individual who signs the Form FDA
1572.*

Statement of Compliance i

Signature Page ii

List of Abbreviations iv

Protocol Summary ...v

[1 Key Roles 1](#key-roles)

[2 Background Information and Scientific Rationale
2](#background-information-and-scientific-rationale)

[2.1 Background Information 2](#background-information)

[2.2 Scientific Rationale 2](#scientific-rationale)

[2.3 Potential Risks and Benefits 2](#potential-risks-and-benefits)

[2.3.1 Potential Risks 3](#potential-risks)

[2.3.2 Known Potential Benefits 3](#known-potential-benefits)

[3 Objectives 4](#objectives)

[4 Study Design 5](#study-design)

[5 Study Population 6](#study-population)

[5.1 Selection of the Study Population
6](#selection-of-the-study-population)

[5.2 Inclusion/Exclusion Criteria 7](#inclusionexclusion-criteria)

[6 STUDY PROCEDURES/EVALUATIONS 8](#study-proceduresevaluations)

[6.1 Study Procedures 8](#study-procedures)

[6.2 Laboratory Evaluations 8](#laboratory-evaluations)

[6.2.1 Laboratory Evaluations/Assays 8](#laboratory-evaluationsassays)

[6.2.2 Specimen Collection, Preparation, Handling and Shipping
8](#specimen-collection-preparation-handling-and-shipping)

[7 Statistical Considerations 10](#statistical-considerations)

[7.1 Study Outcome Measures 10](#study-outcome-measures)

[7.2 Sample Size Considerations 10](#sample-size-considerations)

[7.3 Participant Enrollment and Follow-Up
10](#participant-enrollment-and-follow-up)

[7.4 Analysis Plan 10](#analysis-plan)

[8 Subject Confidentiality 12](#subject-confidentiality)

[8.1 Future Use of Stored Specimens 12](#future-use-of-stored-specimens)

[9 Informed Consent Process 14](#informed-consent-process)

[9.1 Informed Consent/Assent Process (in Case of a Minor or Others
Unable to Consent for Themselves)
15](#informed-consentassent-process-in-case-of-a-minor-or-others-unable-to-consent-for-themselves)

[10 Literature References 16](#literature-references)

SUPPLEMENTS/APPENDICES

  ---------------------- ------------------------------------------------
  AE                     Adverse Event

  CFR                    Code of Federal Regulations

  CIOMS                  Council for International Organizations of
                         Medical Sciences

  CRF                    Case Report Form

  DMID                   Division of Microbiology and Infectious
                         Diseases, NIAID, NIH, DHHS

  DSMB                   Data and Safety Monitoring Board

  FWA                    Federal-Wide Assurance

  GCP                    Good Clinical Practice

  ICF                    Informed Consent Form

  ICH                    International Conference on Harmonisation

  IEC                    Independent or Institutional Ethics Committee

  IRB                    Institutional Review Board

  ISM                    Independent Safety Monitor

  JAMA                   Journal of the American Medical Association

  MOP                    Manual of Procedures

  N                      Number (typically refers to subjects)

  NEJM                   New England Journal of Medicine

  NIAID                  National Institute of Allergy and Infectious
                         Diseases, NIH, DHHS

  NIH                    National Institutes of Health

  OCRA                   Office of Clinical Research Affairs, DMID,
                         NIAID, NIH, DHHS

  OHRP                   Office for Human Research Protections

  ORA                    Office of Regulatory Affairs, DMID, NIAID, NIH,
                         DHHS

  PI                     Principal Investigator

  SAE                    Serious Adverse Event

  SMC                    Safety Monitoring Committee

  SOP                    Standard Operating Procedure

  WHO                    World Health Organization
  ---------------------- ------------------------------------------------

*This list should be expanded to include protocol-specific terms.*

*Limit to 1-2 pages\
Put key words in boldface in Protocol Summary.*

**Title**:

**Population**: *Include sample size, gender, age, general health
status, geographic location*

**Number of Sites**: *3 or fewer, list here; otherwise, list only in an
Appendix and in Section 1*

**Study Duration**: *State duration of study*

**Subject Duration**: *State duration per subject*

**Objectives**:

*Include primary/secondary outcome measures and method by which outcome
will be determined; copy objectives and clinical/laboratory outcome
measures from the appropriate sections of the protocol.*

Primary:

-   

Secondary:

-   

**Schematic of Study Design**: *Optional*

*Example: Flow diagram*

Prior to

Enrollment

Study Visit 1

Study Visit 2

Etc.

# Key Roles

For questions regarding this protocol, contact *(insert name of DMID
Protocol Champion or other appropriate DMID staff) at NIAID/DMID (insert
contact information).*

**Individuals**: **DMID Representative**

> **Principal Investigator**: *Site investigator responsible for
> conducting the study:*
>
> *Provide the following information:*
>
> *Name, degree, title*
>
> *Institution*
>
> *Address*
>
> *Phone Number*
>
> *Fax Number*
>
> *E-mail*

**Institutions**: *Study sites, Clinical laboratory (ies) and other
medical or technical departments and/or institutions, as applicable.*

> *Provide the following information for each organization or
> institution:*
>
> *Institution*
>
> *Address*
>
> *Contact Person*
>
> *Phone Number*
>
> *Fax Number*
>
> *E-mail*

**Optional:** *Consider listing, for example:*

> *Protocol Data Manager, Epidemiologist, Statistician*
>
> *DMID Clinical Affairs Specialist*

# Background Information and Scientific Rationale 

## Background Information 

*See ICH E6 GCP, Section 6.2
(<http://www.fda.gov/cder/guidance/959fnl.pdf>).*

Include:

-   *Hypothesis of study*

-   *A summary of findings from studies that have potential significance
    to proposed study.*

-   *A discussion of important literature and data that are relevant to
    the study and that provide background for the study. List the full
    citations for the references (reference citations are listed in
    Section 10). Discuss deficiencies in the literature and, in general,
    how they will be addressed. Write concisely.*

-   *Applicable clinical, epidemiological or public health background or
    context of the study*

## Scientific Rationale 

-   *Include a description of and justification for selection of study
    population.* *Briefly assess the need to acquire data from humans.
    The desired data may already exist.*

-   *Address the applicability of animal subjects and computer
    simulations in place of human subjects.*

## Potential Risks and Benefits

*Include a discussion of known risks and benefits, if any, to human
subjects*

*Refer to 45 CFR Part 46.116 (a) (2) and 3.*

*http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116*

### Potential Risks

> *Describe in detail any physical, psychological, social, legal,
> economic or any other risks to subjects that the PI foresees, as to
> each of the following:*

-   *Immediate risks*

-   *Long range risks*

-   *Rationale for the necessity of such risks*

-   *Alternative data gathering procedures that have been considered or
    will be considered*

-   *Why alternative procedures may not be feasible*

-   *Why the value of the information to be gained outweighs the risks
    involved.*

### Known Potential Benefits

> *If the research is **beneficial** (i.e., the subject derives a direct
> benefit of either money or treatment from participating in the study),
> describe in detail any physical, psychological, social, legal,
> economic or any other benefits to subjects that the PI foresees.*

# Objectives

*A detailed description of the objectives of the study is included in
this section. These typically include:*

-   *Statement of purpose e.g., to assess, to determine, to compare, to
    evaluate*

-   *Method of assessing how the objective is met, i.e., the study
    outcome measures*

# Study Design

*See ICH E6 GCP, Section 6.4
(<http://www.fda.gov/cder/guidance/959fnl.pdf>).*

*The scientific integrity of the study and the credibility of the data
from the study depend substantially on the study design. A description
of the design of the study should include:*

-   *A description of the design of the study to be conducted, including
    controls*

-   *Approximate time to obtain specimens*

-   *Expected duration of subject participation*

-   *Description of subject participation (e.g., number of times and the
    frequency at which a subject will provide specimens)*

-   *Methods for collecting specimens and data.*

-   *A specific statement of the primary and secondary outcomes to be
    measured during the study (must be consistent with Study Objectives,
    as stated in Section 3)*

# Study Population

*The study population and inclusion/exclusion criteria should be clearly
defined in this section of the protocol. This section should include a
discussion of selection of the study population and inclusion/exclusion
criteria.*

## Selection of the Study Population

*Refer to OHRP Guidance Document, "Categories of Research that May be
Reviewed by the Institutional Review Board (IRB) through an Expedited
Review Procedure" Section: Research Categories, 2 (a) and (b).*

> [*http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm*](http://www.hhs.gov/ohrp/humansubjects/guidance/  expedited98.htm)

*If the study intends to enroll children, pregnant women, prisoners, or
other vulnerable populations, see applicable section of 45 CFR 46
Subpart B -- Additional DHHS Protections Pertaining to Research,
Development and Related Activities Involving Fetuses, Pregnant Women,
and Human In Vitro Fertilization (45 CFR 46.201-46.211); Subpart C --
Additional DHHS Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects (45 CFR 46.301-46.306); Subpart
D -- Additional DHHS Protections in Children Involved as Subjects in
Research (45 CFR 46.401-409). Please refer to these guidelines when
choosing the study population.*

*Refer to:
<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46>.*

-   *Provide the target sample size, including actual numbers to be
    enrolled.*

-   *Describe the gender, race, age and ethnicity of the subjects.
    Provide justification for Exclusion in Ethics/Protection of Human
    Subjects, Section 16.4. Refer to:*

*http://grants2.nih.gov/grants/funding/women_min/women_min.htm*

-   *Provide a rationale for any restrictions in subject selection. For
    instance, if subjects are drawn from an organization that provides
    services only to women, that fact should be stated. Or, if the
    equipment to provide certain measurements requires persons with
    certain physical characteristics, it is better to describe the
    limitations of your subject recruitment based on the requirements of
    the equipment (e.g., require arm length of X inches) rather than
    saying only men will be recruited.*

-   *Indicate from where the study population will be drawn (e.g.,
    inpatient hospital setting, outpatient clinics, student health
    service). Where appropriate (single center studies), include names
    of hospitals, clinics, etc.*

-   *State the PI\'s relationship to any organization or institution
    allowing the PI access to its members or clients, e.g., the PI is an
    employee of the institution, a member or volunteer of the
    organization.*

-   *Describe the general state of health (mental and physical) required
    of the subjects. If it is a requirement of the research that the
    subjects are in good mental or physical health, indicate who will
    determine their mental/physical health and how they will determine
    the subjects\' good mental/physical health, or upon what basis the
    subjects\' fitness will be judged.*

-   *If the subjects are minors, mentally incompetent, or members of any
    other legally restricted group, provide an explanation as to the
    necessity for using these participants.*

-   *If the subjects are minors, and their parents/guardians will not be
    allowed to see the results of the child's participation, the PI must
    state those conditions in the protocol and in the consent form.
    Parents/guardians should be notified of the limitation on their
    access to collected or recorded data before they give informed
    consent.*

-   *If subjects require screening, distinguish between screening
    subjects (e.g., discussing the study with them) vs. enrolling
    subjects (e.g., obtaining informed consent and obtaining samples).
    Note: if screening procedures are required for eligibility (e.g.,
    laboratory tests), there must be a separate screening consent form
    in addition to the informed consent form for study participation.*

## Inclusion/Exclusion Criteria

*The inclusion and exclusion criteria should provide a definition of
subject characteristics required for study entry.*

-   *The same criterion should not be listed as both an inclusion and
    exclusion criterion (e.g., do not state age \>32 years old as an
    inclusion criterion and also age ≤32 years old as an exclusion
    criterion).*

-   *Specify if pregnant and/or breastfeeding women will be enrolled*

-   *If men and women of reproductive capability will be enrolled,
    include details of allowable contraception methods for trial (e.g.,
    licensed hormonal methods).*

# STUDY PROCEDURES/EVALUATIONS

## Study Procedures

-   *Specify the type of information the PI will gather, along with the
    means for collecting and recording it. Include where the data will
    be stored during the study and how long the PI intends to keep the
    data. Describe steps to be taken to assure that the data collected
    are accurate, consistent, complete and reliable and in accordance
    with ICH GCP guidelines and 21 CFR Part 11.*

*Refer to: http://www.fda.gov/ora/compliance_ref/part11/*

-   *State the overall duration of the project. If more than one visit
    will be required, indicate the amount of time required for each
    visit. Indicate the total amount of time required of each subject to
    participate in the project.*

-   *Describe the process for using anonymized samples, if applicable.*

## Laboratory Evaluations

### Laboratory Evaluations/Assays

> *List all laboratory evaluations, if applicable. Include specific test
> components and estimated volume and type of specimens needed for each
> test. Specify laboratory methods (e.g., use consistent laboratory
> method throughout study). Provide description of assays to be
> performed.*

### Specimen Collection, Preparation, Handling and Shipping

#### Instructions for Specimen Preparation, Handling, and Storage

> *Special instructions for the collection, labeling, preparation,
> handling, and storage of specimens should be summarized in this
> section and clearly detailed in a Manual of Procedures. These
> instructions include required temperatures, aliquots of specimens,
> whether samples will be frozen, where they will be stored, how they
> will be labeled, etc. Include a discussion of long-term access and
> consent for future use. Describe the process for using anonymized
> samples, if applicable. There may need to be additional considerations
> for biological specimens, especially biohazardous specimens that
> require special containment.*

#### Specimen Shipment

> *State the frequency with which specimens are to be shipped and to
> what address, if applicable. Include contact information for
> laboratory personnel. Include days and times shipments are allowed,
> and any labeling requirements for specimen shipping. Also, any special
> instructions such as dry ice or wet ice or the completion of a
> specimen-tracking log should be included. Place specific details in a
> Manual of Procedures and reference within the protocol.*

# Statistical Considerations

## Study Outcome Measures

*Discuss how the outcome measures will be measured and transformed, if
relevant, before analysis (e.g., is the primary variable binary,
categorical, or continuous?).*

## Sample Size Considerations

*Provide information needed to validate your calculations, and also to
judge the feasibility of enrolling subjects and obtaining the necessary
number of specimens.*

*In particular, specify all of the following:*

-   *Approach to handling withdrawals and protocol violations*

-   *Statistical method used to calculate the sample size, with a
    reference for it and for any software utilized*

-   *Discuss any measures to decrease bias or increase precision in
    ascertainment of study endpoints (e.g., blinding of laboratory
    staff, use of a central laboratory to perform assays).*

*Present calculations from a suitable range of assumptions to gauge the
robustness of the proposed sample size.*

*Discuss whether the sample size also provides sufficient power for
addressing secondary objectives, or for secondary analyses in key
subgroup populations.*

*In some circumstances, exploratory or pilot studies may be planned for
convenience of obtaining samples.*

## Participant Enrollment and Follow-Up

*Summarize the total number of enrollees and the total duration of
accrual and retention capabilities.*

## Analysis Plan

*This section can be used to elaborate on primary analyses that underlie
the sample size calculation in Section 7.2 above and to describe
secondary analyses for the primary or secondary objectives. Details can
be provided in a separate statistical analysis plan written later, but
prior to performing any analyses.*

*Plans must clearly identify the analyses cohorts, if applicable, and
methods to account for missing, unused or spurious data. If specialized
statistical techniques (e.g., methods for sequencing or microarray
analysis) will be used, please discuss and indicate who will be
performing the analysis.*

# Subject Confidentiality 

*Include procedures for maintaining subject confidentiality, any special
data security requirements, and record retention per the sponsor's
requirements. State whether human subjects will be identifiable directly
or through identifying information. State how the data will be linked to
the subjects during the study. State how and where the data will be
stored, and how it will be protected.*

*Subject confidentiality is held strictly in trust by the participating
investigators, their staff, and the sponsor(s) and their agents. This
confidentiality is extended to cover testing of biological samples and
genetic tests in addition to the clinical information relating to
participating subjects.*

*The study protocol, documentation, data and all other information
generated will be held in strict confidence. No information concerning
the study or the data will be released to any unauthorized third party
without prior written approval of the sponsor.*

*The clinical study site will permit access to all documents and records
that may require inspection by the sponsor or its authorized
representatives, including but not limited to, medical records (office,
clinic or hospital) and pharmacy records for the subjects in this
study.*

*State what the PI will do with the information obtained from the
subjects. Describe which elements of the project might be openly
accessible to other agencies or appear in publications.*

*Describe the immediate use of data by the PI and others. Describe the
long-range use of data by the PI and others. Explain what will happen to
the data upon completion of the study. If the data will be retained
specify for how long and by whom. If the data will be destroyed, specify
the time.*

##  Future Use of Stored Specimens

*If residual specimens will be maintained after the study is complete,
include the provisions for consent and the options that are available
for the volunteer to agree to the future use of his/her specimens. 
Specify the location(s), if other than the clinical site, where
specimens will be maintained, if the site\'s IRB will review future
studies, and protections of confidentiality for any future studies with
the stored specimens (e.g., specimens will be coded, bar-coded,
de-linked). Include a statement that genetic testing will not be
performed if required by the IRB.*

*Refer to Human Research Regulation Chart 2 at:*

*<http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm>.*

*Additional guidance can be provided by OCRA/ORA staff.*

# Informed Consent Process

*Refer to ICH GCP E6, Section 4.8
(<http://www.fda.gov/cder/guidance/959fnl.pdf>).*

*Refer to DHHS Regulation on Informed Consent 45 CFR Part 46 - Subpart
A, 46.116
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116).*

*See also Tips on Informed Consents
(<http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm>).*

*See also Informed Consent Checklist
(<http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm>)*

*Describe the procedures for obtaining and documenting informed consent
of study subjects. Make provisions for special populations, e.g.,
non-English speakers (refer to:
<http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm>),
illiterate or non-writing individuals, vulnerable populations.*

*Informed consent is required for all subjects participating in a
DMID-sponsored study, unless the requirement of informed consent is
specifically waived by the IRB/IEC. In obtaining and documenting
informed consent, the investigator should comply with applicable
regulatory requirements and should adhere to GCP and to the ethical
principles that have their origin in the Declaration of Helsinki. Prior
to the beginning of the clinical study, the investigator should have the
IRB/IEC's written approval/favorable opinion of the written informed
consent form(s) and any other written information to be provided to the
subjects.*

*When seeking informed consent, be sure to give the subject a sufficient
amount of time to consider whether or not to participate. This will
minimize the possibility of coercion or undue influence. The informed
consent document is the only evidence that the subject was informed of
the risks and benefits of the study. It also provides evidence that the
subject gave consent, at that time, to participate.*

*The subject may revoke consent orally or in writing at any time and for
any reason. Therefore, the PI must continually monitor the subject\'s
consent. All informed consent documents must be written in language
understandable by each member of the subject population, usually at the
sixth to eighth grade reading level.*

*Identify different consent forms that are needed for the study (e.g.,
screening, study participation, HIV screening, future use specimens,
plasmapheresis, assent form for minors).*

*Example text:*

*"Informed consent is a process that is initiated prior to the
individual's agreeing to participate in the study and continuing
throughout the individual's study participation. Extensive discussion of
risks and possible benefits of participation in this study will be
provided to the subjects and their families. Consent forms describing in
detail the study procedures and risks are given to the subject and
written documentation of informed consent is required prior to enrolling
in the study. Consent forms will be IRB approved and the subject will be
asked to read and review the document. Upon reviewing the document, the
investigator will explain the research study to the subject and answer
any questions that may arise. The subjects will sign the informed
consent document prior to being enrolled in the study. The subjects
should have the opportunity to discuss the study with their surrogates
or think about it prior to agreeing to participate. The subjects may
withdraw consent at any time throughout the course of the study. A copy
of the informed consent document will be given to the subjects for their
records. The rights and welfare of the subjects will be protected by
emphasizing to them that the quality of their medical care will not be
adversely affected if they decline to participate in this study."*

*Provide each institution with a sample consent form for subject
participation. The consent form should be separate from the protocol
document.*

## Informed Consent/Assent Process (in Case of a Minor or Others Unable to Consent for Themselves)

*Refer to ICH E6, Section 4.8.12
(<http://www.fda.gov/cder/guidance/959fnl.pdf>).*

*When a study includes subjects who may be enrolled in the study only
with the consent of the subject's legally acceptable representative
(e.g., minors or subjects unable to consent for themselves), the subject
should be informed about the study to the extent compatible with the
subject's understanding. If capable, the subject should assent and sign
and personally date the written consent form. A separate IRB-approved
assent form, describing (in simplified terms) the details of the study,
study procedures and risks may be used. Assent forms do not substitute
for the consent form signed by the subject's legally acceptable
representative. Consult with the institutions policies regarding
enrollment of participants who are unable to provide informed consent
for themselves.*

# Literature References

*Include a list of relevant literature references in this section. Use a
consistent, standard, modern format, which might be dependent upon the
required format for the anticipated journal for publication (e.g., NEJM,
JAMA). The preferred format is the Vancouver format, used in the
American Medical Association Manual of Style.*

*Examples:*

*Journal citation:\
*Davis JT, Allen HD, Powers JD, Cohen DM. Population requirements for
capitation planning in pediatric cardiac surgery. *Arch Pediatr Adolesc
Med*. 1996;150(1):257-259.

*Whole Book citation:\
*Sherlock S, Dooley J. *Diseases of the Liver and Biliary System.* 9th
ed. Oxford, England: Blackwell Scientific Publications; 1993.

*Chapter in a Book citation:\
*Cole BR. Cystinosis and cystinuria. In: Jacobson HR, Striker GE, Klarh
S, eds. *The Principles and Practice of Nephrology*. Philadelphia, PA:
BC Decker Inc.; 1991:396-403.

*A full listing of Vancouver style guidelines can be found at:\
*International Committee of Medical Journal Editors. Uniform
Requirements for Manuscripts Submitted to Biomedical Journals. *JAMA*.
1997;277:927-934.

*You may also refer to:\
http://www.library.uwa.edu.au/guides/citingsources/vancouver.html*

**SUPPLEMENTS/APPENDICES**

Required Documents:

> *Provide with protocol:*

-   *Consent Form*

-   *Assent Form, if applicable*

-   *Future Use Consent, if applicable*

-   *Schedule of Events*

> *Can be provided at a later time:*

-   *CVs*

-   *Conflict of Interest Statement (COI)*

-   *Confidentiality Agreement (CDA)*

-   *Manual of Procedures*

-   *Safety Monitoring Plan*

-   *Site Monitoring Plan*

-   *Copies of Case Report Form(s)*

Additional/optional supplements:

-   *Biosafety Precautions*

-   *Repository Instructions*

-   *Laboratory Handling*

-   *Site Roster*