Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board - Appendix 2

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