Sample Protocol Template - Home | NHLBI, NIH



Table of Contents

A Introduction 3

A1 Study Abstract 3

A2 Primary Hypothesis 3

A3 Purpose of the Study Protocol 3

B Background 3

B1 Prior Literature and Studies 3

B2 Rationale for this Study 3

C Study Objectives 3

C1 Primary Aim 3

C2 Secondary Aim 3

C3 Rationale for the Selection of Outcome Measures 3

D Investigational Agent 3

D1 Preclinical Data 3

D2 Clinical Data to Date 4

D3 Dose Rationale and Risk/Benefits 4

E Study Design 4

E1 Overview or Design Summary 4

E2 Subject Selection and Withdrawal 4

2.a Inclusion Criteria 4

2.a Exclusion Criteria 4

2.b Ethical Considerations 4

2.c Subject Recruitment Plans and Consent Process 4

2.d Randomization Method and Blinding 4

2.e Risks and Benefits 4

2.f Early Withdrawal of Subjects 4

2.g When and How to Withdraw Subjects 4

2.h Data Collection and Follow-up for Withdrawn Subjects 4

E3 Study Drug 5

3.a Description 5

3.b Treatment Regimen 5

3.c Method for Assigning Subjects to Treatment Groups 5

3.d Preparation and Administration of Study Drug 5

3.e Subject Compliance Monitoring 5

3.f Prior and Concomitant Therapy 5

3.g Packaging 5

3.h Blinding of Study Drug 5

3.i Receiving, Storage, Dispensing and Return 5

F Study Procedures 5

F1 Screening for Eligibility 5

F2 Schedule of Measurements 5

F3 Visit 1 5

F4 Visit 2 etc. 6

F5 Safety and Adverse Events 6

5.a Safety and Compliance Monitoring 6

5.b Medical Monitoring 6

i Investigator only 6

ii Independent expert to monitor 6

iii Institutional Data and Safety Monitoring Board 6

iv Independent Data and Safety Monitoring Board 6

5.c Definitions of Adverse Events 6

5.d Classification of Events 6

i Relationship 6

ii Severity 6

iii Expectedness 6

5.e Data Collection Procedures for Adverse Events 6

5.f Reporting Procedures 6

5.g Adverse Event Reporting Period 7

5.h Post-study Adverse Event 7

F6 Study Outcome Measurements and Ascertainment 7

G Statistical Plan 7

G1 Sample Size Determination and Power 7

G2 Interim Monitoring and Early Stopping 7

G3 Analysis Plan 7

G4 Statistical Methods 7

G5 Missing Outcome Data 7

G6 Unblinding Procedures 7

H Data Handling and Record Keeping 7

H1 Confidentiality and Security 7

H2 Training 7

H3 Case Report Forms and Source Documents 7

H4 Records Retention 8

H5 Performance Monitoring 8

I Study Monitoring, Auditing, and Inspecting 8

I1 Study Monitoring Plan 8

I2 Auditing and Inspecting 8

J Study Administration 8

J1 Organization and Participating Centers 8

J2 Funding Source and Conflicts of Interest 8

J3 Committees 8

J4 Subject Stipends or Payments 8

J5 Study Timetable 8

K Publication Plan 8

L Attachments 9

L1 Tables 9

L2 Informed consent documents 9

L3 Patient education brochures 9

L4 Special procedures protocols 9

L5 Questionnaires or surveys 9

M References 9

Introduction

1 Study Abstract

2 Primary Hypothesis

3 Purpose of the Study Protocol

Background

1 Prior Literature and Studies

2 Rationale for this Study

Study Objectives

1 Primary Aim

2 Secondary Aim

3 Rationale for the Selection of Outcome Measures

Investigational Agent

1 Preclinical Data

2 Clinical Data to Date

3 Dose Rationale and Risk/Benefits

Study Design

1 Overview or Design Summary

2 Subject Selection and Withdrawal

1 Inclusion Criteria

2 Exclusion Criteria

3 Ethical Considerations

4 Subject Recruitment Plans and Consent Process

5 Randomization Method and Blinding

6 Risks and Benefits

7 Early Withdrawal of Subjects

8 When and How to Withdraw Subjects

9 Data Collection and Follow-up for Withdrawn Subjects

3 Study Drug

1 Description

2 Treatment Regimen

3 Method for Assigning Subjects to Treatment Groups

4 Preparation and Administration of Study Drug

5 Subject Compliance Monitoring

6 Prior and Concomitant Therapy

7 Packaging

8 Blinding of Study Drug

9 Receiving, Storage, Dispensing and Return

Study Procedures

1 Screening for Eligibility

2 Schedule of Measurements

3 Visit 1

4 Visit 2 etc.

5 Safety and Adverse Events

1 Safety and Compliance Monitoring

2 Medical Monitoring

1 Investigator only

2 Independent expert to monitor

3 Institutional Data and Safety Monitoring Board

4 Independent Data and Safety Monitoring Board

3 Definitions of Adverse Events

4 Classification of Events

1 Relationship

2 Severity

3 Expectedness

5 Data Collection Procedures for Adverse Events

6 Reporting Procedures

7 Adverse Event Reporting Period

8 Post-study Adverse Event

6 Study Outcome Measurements and Ascertainment

Statistical Plan

1 Sample Size Determination and Power

2 Interim Monitoring and Early Stopping

3 Analysis Plan

4 Statistical Methods

5 Missing Outcome Data

6 Unblinding Procedures

Data Handling and Record Keeping

1 Confidentiality and Security

2 Training

3 Case Report Forms and Source Documents

4 Records Retention

5 Performance Monitoring

Study Monitoring, Auditing, and Inspecting

1 Study Monitoring Plan

2 Auditing and Inspecting

Study Administration

1 Organization and Participating Centers

2 Funding Source and Conflicts of Interest

3 Committees

4 Subject Stipends or Payments

5 Study Timetable

Publication Plan

Attachments

1 Tables

2 Informed consent documents

3 Patient education brochures

4 Special procedures protocols

5 Questionnaires or surveys

References

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