NHLBI Sample Protocol Template

September, 2006

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TABLE OF CONTENTS

INTRODUCTION.................................................................................................................................3
A1
A2
A3

STUDY ABSTRACT...........................................................................................................................3
PRIMARY HYPOTHESIS.....................................................................................................................3
PURPOSE OF THE STUDY PROTOCOL...............................................................................................3

BACKGROUND....................................................................................................................................3
B1
B2

PRIOR LITERATURE AND STUDIES...................................................................................................3

RATIONALE FOR THIS STUDY...........................................................................................................3

STUDY OBJECTIVES..........................................................................................................................3
C1
C2
C3

PRIMARY AIM..................................................................................................................................3
SECONDARY AIM.............................................................................................................................3
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES...........................................................3

INVESTIGATIONAL AGENT.............................................................................................................3
D1
D2
D3

PRECLINICAL DATA.........................................................................................................................3
CLINICAL DATA TO DATE................................................................................................................4
DOSE RATIONALE AND RISK/BENEFITS...........................................................................................4

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

STUDY PROCEDURES.......................................................................................................................5
F1
F2
F3

SCREENING FOR ELIGIBILITY...........................................................................................................5

SCHEDULE OF MEASUREMENTS......................................................................................................5
VISIT 1.............................................................................................................................................5

NHLBI Sample Protocol Template

September, 2006

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F4
F5

VISIT 2 ETC......................................................................................................................................6
SAFETY AND ADVERSE EVENTS......................................................................................................6
5.a
Safety and Compliance Monitoring...........................................................................................6
5.b
Medical Monitoring...................................................................................................................6
i
ii
iii
iv

5.c
5.d
i
ii
iii

5.e
5.f
5.g
5.h
F6
G

Investigator only.......................................................................................................................................6
Independent expert to monitor..................................................................................................................6
Institutional Data and Safety Monitoring Board.......................................................................................6
Independent Data and Safety Monitoring Board.......................................................................................6

Definitions of Adverse Events....................................................................................................6

Classification of Events..............................................................................................................6
Relationship.............................................................................................................................................6
Severity.................................................................................................................................................... 6
Expectedness............................................................................................................................................6

Data Collection Procedures for Adverse Events........................................................................6

Reporting Procedures.................................................................................................................6
Adverse Event Reporting Period................................................................................................7
Post-study Adverse Event...........................................................................................................7
STUDY OUTCOME MEASUREMENTS AND ASCERTAINMENT............................................................7

STATISTICAL PLAN...........................................................................................................................7
G1
G2
G3
G4
G5
G6

SAMPLE SIZE DETERMINATION AND POWER...................................................................................7

INTERIM MONITORING AND EARLY STOPPING................................................................................7
ANALYSIS PLAN...............................................................................................................................7
STATISTICAL METHODS...................................................................................................................7
MISSING OUTCOME DATA...............................................................................................................7
UNBLINDING PROCEDURES..............................................................................................................7

DATA HANDLING AND RECORD KEEPING.................................................................................7

H1
H2
H3
H4
H5

CONFIDENTIALITY AND SECURITY..................................................................................................7

TRAINING.........................................................................................................................................7
CASE REPORT FORMS AND SOURCE DOCUMENTS..........................................................................7
RECORDS RETENTION......................................................................................................................8
PERFORMANCE MONITORING..........................................................................................................8

STUDY MONITORING, AUDITING, AND INSPECTING.............................................................8

I1
I2

STUDY MONITORING PLAN..................................................................................................................8

AUDITING AND INSPECTING.................................................................................................................8
STUDY ADMINISTRATION...............................................................................................................8

J1
J2
J3
J4
J5

ORGANIZATION AND PARTICIPATING CENTERS....................................................................................8

FUNDING SOURCE AND CONFLICTS OF INTEREST................................................................................8
COMMITTEES........................................................................................................................................8
SUBJECT STIPENDS OR PAYMENTS.......................................................................................................8
STUDY TIMETABLE...............................................................................................................................8

PUBLICATION PLAN.........................................................................................................................8

ATTACHMENTS...................................................................................................................................9
L1
L2
L3
L4
L5

TABLES............................................................................................................................................9
INFORMED CONSENT DOCUMENTS...................................................................................................9
PATIENT EDUCATION BROCHURES....................................................................................................9
SPECIAL PROCEDURES PROTOCOLS..................................................................................................9
QUESTIONNAIRES OR SURVEYS........................................................................................................9
REFERENCES......................................................................................................................................9

NHLBI Sample Protocol Template

September, 2006

______________________________________________________________________________________