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