Last revised: 

DSMB Collaboration with the IRB
NCI guidelines are widely considered to be the most comprehensive and set forth requirements for DSMB composition and function; note that it is required that a majority of the members be drawn from outside the institution (or institute) conducting the study. DSMB membership is usually comprised of:

  • Experts in the fields of medicine and science that are applicable to the study,
  • Statistical experts,
  • Lay representatives, and
  • Other who can offer an unbiased assessment of the study progress

The DSMB is not specifically required to communicate with the IRB, but the intent is clear that the important information get to the IRB: "The study leadership will provide information on cumulative toxicities and relevant recommendations to the local principal investigators, to be shared with their IRBs."

DSMP Checklist

  • Primary and secondary outcome measures
  • Inclusion/exclusion criteria
  • Sample size
  • List of participating enrolling clinics or data collection centers
  • Projected timetable
  • Target population distribution (e.g., women, minorities, etc.)Data acquisition and transmission
  • Data entry methods
  • Data analysis plan
  • Quality assurance plan
  • Reporting mechanisms of AEs/SAEs to the IRB, FDA, and NIDA.
  • Reporting mechanisms of IRB actions to NIDA
  • Report of changes or amendments to the protocol
  • Trial stopping rules
  • Conflict of interest
  • Potential risks and benefits for participants
  • Collection and reporting of AEs and SAEs
  • Management of SAEs or other study risks
  • Plans for Interim Analysis of efficacy data
  • Responsibility for data and safety monitoring
  • Frequency of DSM reviews
  • Content of DSM report
  • DSM Board Plan (if applicable

Need assistance or have clinical study management questions?
Please contact CTSI Design Services.