Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board - Appendix 2
Revised March 2004
Ongoing Protocol Review
Outline of items to be reviewed
Admission Data
- Screened, admitted, reported, active
- Subject eligibility
- Demographic characteristics (total, by group)
- Recruitment and retention (total, by group)
Protocol Compliance
- Expected recruitment rate
- Study drop-outs and reason
- Data QA report
- Overall data flow
- CRFs collected, received, entered, reported by relevant CRF
- Protocol deviations
- Protocol violations
- Missing data
- Staff omission
- Subject refusal to provide data
- Monitor holding/stopping rules (e.g., lower dose)
Safety Data Report (total and by group)
- Vital signs
- Any relevant medical, psychosocial or laboratory data
- AEs (summarized in tables)
- SAEs (individual reports)
- Concomitant medications
- Concomitant illnesses
Efficacy Data Report
- Total or by group
- Masked or unblinded
- With or without statistical analysis
- Primary outcome variable
- Secondary outcome variables
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