**TITLE**

**DMID Protocol Number:**

**Sponsored by:**

National Institute of Allergy and Infectious Diseases (NIAID)

**DMID Funding Mechanism:**

**Principal Investigator:**

**DMID Protocol Champion:**

**Draft or Version Number:**

**Day Month Year**

Statement of Compliance

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 |                                         |     |              |
| I    |                                         |     |              |
| nves |                                         |     |              |
| tiga |                                         |     |              |
| tor: |                                         |     |              |
+------+-----------------------------------------+-----+--------------+
| Sig  |                                         | Da  |              |
| ned: |                                         | te: |              |
+------+-----------------------------------------+-----+--------------+
|      | *Name*                                  |     |              |
|      |                                         |     |              |
|      | *Title*                                 |     |              |
+------+-----------------------------------------+-----+--------------+

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 2](#potential-risks)

[2.3.2 Known Potential Benefits 2](#known-potential-benefits)

[3 Objectives 3](#objectives)

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

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

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

[5.2 Inclusion/Exclusion Criteria 5](#inclusionexclusion-criteria)

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

[6.1 Study Procedures 6](#study-procedures)

[6.2 Laboratory Evaluations 6](#laboratory-evaluations)

[6.2.1 Laboratory Evaluations/Assays 6](#laboratory-evaluationsassays)

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

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

[7.1 Study Outcome Measures 7](#study-outcome-measures)

[7.2 Sample Size Considerations 7](#sample-size-considerations)

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

[7.4 Analysis Plan 7](#analysis-plan)

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

[8.1 Future Use of Stored Specimens 8](#future-use-of-stored-specimens)

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

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

[10 Literature References 10](#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
  ---------------------- ------------------------------------------------

**Title**:

**Population**:

**Number of Sites**:

**Study Duration**:

**Subject Duration**:

**Objectives**:

Primary:

-   

Secondary:

-   

**Schematic of Study Design**:

# Key Roles

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

> **Principal Investigator**:

**Institutions**:

# Background Information and Scientific Rationale 

## Background Information 

## Scientific Rationale 

## Potential Risks and Benefits

### Potential Risks

### Known Potential Benefits

# Objectives

# Study Design

# Study Population

## Selection of the Study Population

## Inclusion/Exclusion Criteria

# STUDY PROCEDURES/EVALUATIONS

## Study Procedures

## Laboratory Evaluations

### Laboratory Evaluations/Assays

### Specimen Collection, Preparation, Handling and Shipping

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

#### Specimen Shipment

# Statistical Considerations

## Study Outcome Measures

## Sample Size Considerations

## Participant Enrollment and Follow-Up

## Analysis Plan

# Subject Confidentiality

##  Future Use of Stored Specimens

# Informed Consent Process

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

# Literature References

**SUPPLEMENTS/APPENDICES**