DMID Protocol TemplateVersion 3.0

28 March 2011

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TITLE

DMID Protocol Number:

DMID Funding Mechanism:(eg, grant #, contract #)

Pharmaceutical Support Provided by:(if applicable)

Other Identifying Numbers:

IND Sponsor:(if applicable. Do not include IND number)

Principal Investigator:

DMID Protocol Champion:

DMID Medical Monitor:

DMID Clinical Affairs Specialist:

DMID Regulatory Affairs Specialist:(if applicable)

Draft or Version Number:(Refer to DMID SOP for assigning version numbers)

Day Month Year
(Write out the month and use international date format, eg, 23 January 2004)

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 Investigator:
Signed: / Date:
Name
Title

Table of Contents

Page

Statement of Compliance

Signature Page

Table of Contents

List of Abbreviations

Protocol Summary

1Key Roles

2Background Information and Scientific Rationale

2.1Background Information

2.2Rationale

2.3Potential Risks and Benefits

2.3.1Potential Risks

2.3.2Known Potential Benefits

3Objectives

3.1Study Objectives

3.2Study Outcome Measures

3.2.1Primary Outcome Measures

3.2.2Secondary Outcome Measures

4Study Design

4.1Substudies (if applicable)

5Study Enrollment and Withdrawal

5.1Subject Inclusion Criteria

5.2Subject Exclusion Criteria

5.3Treatment Assignment Procedures

5.3.1Randomization Procedures

5.3.2Masking Procedures

5.3.3Reasons for Withdrawal

5.3.4Handling of Withdrawals

5.3.5Termination of Study

6Study Intervention/Investigational Product

6.1Study Product Description

6.1.1Acquisition

6.1.2Formulation, Packaging, and Labeling

6.1.3Product Storage and Stability

6.2Dosage, Preparation and Administration of Study Intervention/Investigational Product

6.3Modification of Study Intervention/Investigational Product for a Participant

6.4Accountability Procedures for the Study Intervention/Investigational Product(s)

6.5Assessment of Subject Compliance with Study Intervention/Investigational Product

6.6Concomitant Medications/Treatments

7Study Schedule

7.1Screening

7.2Enrollment/Baseline

7.3Follow-up

7.4Final Study Visit

7.5Early Termination Visit

7.6Unscheduled Visit

8Study Procedures/Evaluations

8.1Clinical Evaluations

8.2Laboratory Evaluations

8.2.1Clinical Laboratory Evaluations

8.2.2Special Assays or Procedures

8.2.3Specimen Preparation, Handling, and Shipping

9Assessment of Safety

9.1Specification of Safety Parameters

9.2Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters

9.2.1Adverse Events

9.2.2Reactogenicity (for Vaccine Studies and Some Therapeutic Trials)

9.2.3Serious Adverse Events

9.2.4Procedures to be Followed in the Event of Abnormal Laboratory Test Values or Abnormal Clinical Findings

9.3Reporting Procedures

9.3.1Serious Adverse Events

9.3.2Regulatory Reporting for Studies Conducted Under DMIDSponsored IND

9.3.3Regulatory Reporting for Studies Not Conducted Under DMIDSponsored IND

9.3.4Other Adverse Events (if applicable)

9.3.5Reporting of Pregnancy

9.4Type and Duration of Follow-up of Subjects after Adverse Events

9.5Halting Rules

9.6Safety Oversight (ISM plus SMC or DSMB)

10Clinical Monitoring

10.1Site Monitoring Plan

11Statistical Considerations

11.1Study Hypotheses

11.2Sample Size Considerations

11.3Planned Interim Analyses (if applicable)

11.3.1Safety Review

11.3.2Immunogenicity or Efficacy Review

11.4Final Analysis Plan

12Source Documents and Access to Source Data/Documents

13Quality Control and Quality Assurance

14Ethics/Protection of Human Subjects

14.1Ethical Standard

14.2Institutional Review Board

14.3Informed Consent Process

14.3.1Informed Consent/Assent Process (in Case of a Minor)

14.4Exclusion of Women, Minorities, and Children (Special Populations)

14.5Subject Confidentiality

14.6Study Discontinuation

14.7Future Use of Stored Specimens

15Data Handling and Record Keeping

15.1Data Management Responsibilities

15.2Data Capture Methods

15.3Types of Data

15.4Timing/Reports

15.5Study Records Retention

15.6Protocol Deviations

16Publication Policy

17Literature References

SupplementS/Appendices

Appendix A: Schedule of Events

List of Abbreviations

AE / Adverse Event/Adverse Experience
CFR / Code of Federal Regulations
CIOMS / Council for International Organizations of Medical Sciences
CONSORT / Consolidated Standards of Reporting Trials
CFR / Code of Federal Regulations
CRF / Case Report Form
CRO / Contract Research Organization
DCC / Data Coordinating Center
DHHS / Department of Health and Human Services
DMID / Division of Microbiology and Infectious Diseases, NIAID, NIH, DHHS
DSMB / Data and Safety Monitoring Board
eCRF / Electronic Case Report Form
FDA / Food and Drug Administration
FWA / Federalwide Assurance
GCP / Good Clinical Practice
HIPAA / Health Insurance Portability and Accountability Act
IB / Investigator’s Brochure
ICF / Informed Consent Form
ICH / International Conference on Harmonisation
ICMJE / International Committeeof Medical Journal Editors
IDE / Investigational Device Exemption
IEC / Independent or Institutional Ethics Committee
IND / Investigational New Drug Application
IRB / Institutional Review Board
ISM / Independent Safety Monitor
JAMA / Journal of the American Medical Association
MedDRA  / Medical Dictionary for Regulatory Activities
MOP / Manual of Procedures
N / Number (typically refers to subjects)
NCI / National Cancer Institute, NIH, DHHS
NDA / New Drug Application
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
OHSR / Office for Human Subjects Research
ORA / Office of Regulatory Affairs, DMID, NIAID, NIH, DHHS
PHI / Protected Health Information
PI / Principal Investigator
PK / Pharmacokinetics
QA / Quality Assurance
QC / Quality Control
SAE / Serious Adverse Event/Serious Adverse Experience
SMC / Safety Monitoring Committee
SOP / Standard Operating Procedure
US / United States
WHO / World Health Organization

Please modify list to include your protocol-specific terms.

Protocol Summary

Title:
Phase:
Population:
Number of Sites:
Study Duration:
Subject Participation Duration:
Description of Agent or Intervention:
Objectives: / Primary:
Secondary:
Description of Study Design:
Estimated Time to Complete Enrollment:

Schematic of Study Design:

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1

DMID Protocol TemplateVersion 3.0

28 March 2011

______

1Key Roles

Individuals:
Protocol Champion:
Principal Investigator:
Medical Monitor: (if applicable)
Institutions:
Optional:

2Background Information and Scientific Rationale

2.1Background Information

2.2Rationale

2.3Potential Risks and Benefits

2.3.1Potential Risks

2.3.2Known Potential Benefits

3Objectives

3.1Study Objectives

3.2Study Outcome Measures

3.2.1Primary Outcome Measures

3.2.2Secondary Outcome Measures

4Study Design

4.1Substudies (if applicable)

5Study Enrollment and Withdrawal

5.1Subject Inclusion Criteria

5.2Subject Exclusion Criteria

5.3Treatment Assignment Procedures

5.3.1Randomization Procedures

5.3.2Masking Procedures

5.3.3Reasons for Withdrawal

5.3.4Handling of Withdrawals

5.3.5Termination of Study

6Study Intervention/Investigational Product

6.1Study Product Description

6.1.1Acquisition

6.1.2Formulation, Packaging, and Labeling

6.1.3Product Storage and Stability

6.2Dosage, Preparation and Administration of Study Intervention/Investigational Product

6.3Modification of Study Intervention/Investigational Product for a Participant

6.4Accountability Procedures for the Study Intervention/Investigational Product(s)

6.5Assessment of Subject Compliance with Study Intervention/Investigational Product

6.6Concomitant Medications/Treatments

7Study Schedule

7.1Screening

7.2Enrollment/Baseline

7.3Follow-up

7.4Final Study Visit

7.5Early Termination Visit

7.6Unscheduled Visit

8Study Procedures/Evaluations

8.1Clinical Evaluations

8.2Laboratory Evaluations

8.2.1Clinical Laboratory Evaluations

8.2.2Special Assays or Procedures

8.2.3Specimen Preparation, Handling, and Shipping

8.2.3.1Instructions for Specimen Preparation, Handling, and Storage
8.2.3.2Specimen Shipment

9Assessment of Safety

9.1Specification of Safety Parameters

9.2Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters

9.2.1Adverse Events

9.2.2Reactogenicity (for Vaccine Studies and Some Therapeutic Trials)

9.2.3Serious Adverse Events

9.2.4Procedures to be Followed in the Event of Abnormal Laboratory Test Values or Abnormal Clinical Findings

9.3Reporting Procedures

9.3.1Serious Adverse Events

9.3.2Regulatory Reporting for Studies Conducted Under DMIDSponsored IND

9.3.3Regulatory Reporting for Studies Not Conducted Under DMIDSponsored IND

9.3.4Other Adverse Events (if applicable)

9.3.5Reporting of Pregnancy

9.4Type and Duration of Follow-up of Subjects after Adverse Events

9.5Halting Rules

9.6Safety Oversight (ISM plus SMC or DSMB)

10Clinical Monitoring

10.1Site Monitoring Plan

11Statistical Considerations

11.1Study Hypotheses

11.2Sample Size Considerations

11.3Planned Interim Analyses (if applicable)

11.3.1Safety Review

11.3.2Immunogenicity or Efficacy Review

11.4Final Analysis Plan

12Source Documents and Access to Source Data/Documents

13Quality Control and Quality Assurance

14Ethics/Protection of Human Subjects

14.1Ethical Standard

14.2Institutional Review Board

14.3Informed Consent Process

14.3.1Informed Consent/Assent Process (in Case of a Minor)

14.4Exclusion of Women, Minorities, and Children (Special Populations)

14.5Subject Confidentiality

14.6Study Discontinuation

14.7Future Use of Stored Specimens

15Data Handling and Record Keeping

15.1Data Management Responsibilities

15.2Data Capture Methods

15.3Types of Data

15.4Timing/Reports

15.5Study Records Retention

15.6Protocol Deviations

16Publication Policy

17Literature References

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DMID Protocol TemplateVersion 2.0

28 September 2005

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SupplementS/Appendices

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1

DMID Protocol TemplateVersion 2.0

28 September 2005

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Appendix A: Schedule of Events

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