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Data Safety Monitoring Board (DSMB)

Data Safety Monitoring Board (DSMB)

Everything you need to know to create a DSMB.

DSMB Support we provide: 

  • Letter of Support (LOS) for grant applications, upon request
  • Detailed review of study related documents 
  • Intake meeting with Principal Investigator (PI), DSMB Chair and DSMB program manager
  • Initial DSMB meeting with study team, DSMB members and NIH representatives, if applicable
  • Data and safety review meetings with study team, DSMB members and NIH representatives, if applicable
  • Executive meetings with PI and DSMB Chair
  • Ad hoc/prompt reviews for safety events
  • Study Terminations 

Request support for DSMB by contacting the CTSI Regulatory Knowledge and Support.

The CTSI DSMB is a group composed of a DSMB Program Chair, a DSMB program manager, a biostatistician and two to three experts in the field of research being studied. Optional DSMB members may include a clinical trial methodology expert, patient advocate and a/or bioethicist. Voting DSMB members must be free of any significant financial, scientific and academic conflict of interest with the study and study PI.  

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