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