NHLBI Sample Protocol Template

September, 2006

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A Study Design
A.1 Overview or Design Summary
A.2 Subject Selection and Withdrawal
2.a

Inclusion Criteria

2.b

Exclusion Criteria

2.c

Ethical Considerations

2.d

Subject Recruitment Plans and Consent Process

2.e

Randomization Method and Blinding

2.f

Risks and Benefits

2.g

Early Withdrawal of Subjects

2.h

When and How to Withdraw Subjects

2.i

Data Collection and Follow-up for Withdrawn Subjects

A.3 Study Drug

NHLBI Sample Protocol Template

September, 2006

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3.a

Description

3.b

Treatment Regimen

3.c

Method for Assigning Subjects to Treatment Groups

3.d

Preparation and Administration of Study Drug

3.e

Subject Compliance Monitoring

3.f

Prior and Concomitant Therapy

3.g

Packaging

3.h

Blinding of Study Drug

3.i

Receiving, Storage, Dispensing and Return