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NIDA

Guidelines for Establishing and Operating a Data and Safety Monitoring Board - Appendix 1

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

This page was last updated March 2004

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