White Paper

Understanding how to Build and Leverage a DSMB Statistical Plan

The DSMB's statistical center is critical in ensuring the DSMB has accurate data to monitor participant safety, providing:

  • DSMB statistical analysis plans (SAPs)
  • SAS-derived dataset programs
  • Tables, listings, and graphs (TLG) programming
  • SAS programming validation per 21 CFR Part 11
  • Periodic statistical reports for the DSMB per SAP
  • Unblinded statistician(s) for the DSMB

Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.

Download the white paper.

Who Should Watch?

CEU Credits

Certificate of Attendance

Time: 1 p.m. ET, 12 p.m. CT, 10 a.m. PT
Duration: 1 hour

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