Revised March 2004
Initial Protocol Review
Outline of protocol items to be reviewed
Statement of protocol design (e.g., blinding, control group)
Characteristics of study data collection site(s)
Inclusion/exclusion criteria
Randomization/stratification plan
Definition of participants (e.g., screened, enrolled, randomized, training, treated, drop out, lost to follow-up)
Intervention definition
- Dosage and frequency
- Manual (specification for behavioral studies)
Reasons to discontinue participation
- Safety rules
- Behavioral rules
- Missed assessments rules
Reasons to change treatment regimen
Outcome measures
- Primary
- Secondary
Sample size
- Calculation
- Definition of subjects used for calculation (usually those randomized)
Key adherence variables
Key safety variables (e.g., BP, pulse, liver function tests)
Data analysis plan
Interim analysis plan
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