The Weill Cornell Medicine (WCM) DSMB is available to aid WCM principal investigators and the Institutional Review Board (IRB) in providing an independent means of data and safety monitoring for clinical trials that involve significant risk to research subjects. The WCM DSMB reviews interim data on a schedule commensurate with the needs of a given protocol to evaluate research subject safety, rates of accrual, and efficacy of experimental intervention. After each evaluation, the Board provides the principal investigator with recommendations for protocol modification, continuation or termination.
Studies for which the WCM DSMB is appropriate as an independent method of monitoring include:
- Large, multi-site, randomized, blinded, and Phase III trials
- Phase I and II studies for which risk to the subjects appears unusually high
- Phase I and II studies for which the principal investigator is the IND/IDE sponsor or manufacturer and independent monitoring is required to maintain the integrity of the trial
- Gene transfer studies
- Studies with vulnerable populations or risky interventions/procedures or any other factors that might indicate high morbidity/mortality end-points
- Studies with high risk of toxicity or other major medical risks
This site aims to provide extensive information concerning the utilization of the WCM DSMB and the creation of your data and safety monitoring plan. If you are unsure of whether your study needs a DSMB, contact firstname.lastname@example.org for assistance.
|WCM DSMB Periodic Report Form (ePRF)||Link|
|WCM DSMB New Protocol Presentation Slides||Power Point|
|Data and Safety Monitoring Board (DSMB) and Data and Safety Monitoring Plan (DSMP) Overview||TWIST Presentation|
10/14/2019: New versions of the Enrollment Summary Table and Multi-site/arm Enrollment Summary Table were updated with new category definitions and instructions for clarity.