Understanding how to Build and Leverage a DSMB Statistical Plan

The data safety monitoring board (DSMB) statistical center’s statisticians and programmers statistical center is critical role in ensuring the DSMB has accurate data to monitor participant safety, including:

• Developing DSMB statistical analysis plans (SAPs)
• Creating SAS-derived dataset programs
• Creating tables, listings, and graphs (TLG) programming
• Validating the SAS programming per 21 CFR Part 11 standards
• Preparing periodic statistical reports for the DSMB per SAP
• Serving as unblinded statistician(s) on 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.