An Introduction to Managing Data Challenges with a DSMB [Video]

Learn how Data and Safety Monitoring Boards (DSMBs) protect participants and keep trials scientifically sound, plus how to prepare clean, blinded interim packages that support clear, timely recommendations.

In this explainer, we cover what a DSMB is, when one is warranted, and how to separate its role from the ethics committee. You’ll hear the difference between the DSMB charter and the Data Safety Monitoring Plan, how to pre-specify interim reviews and thresholds, and the data-management steps that matter most: aligning site entry and cleaning targets, reconciling external feeds, protecting blinding, standardising the DSMB packet, rehearsing timelines, and documenting decisions. We also flag common pitfalls that delay reviews or risk unblinding, so you can avoid them.

At Quanticate, our biometrics and data management teams support sponsors with DSMB readiness end to end: charter input, DSMP alignment, interim analysis planning, secure data pipelines, external data reconciliation, blinded outputs, standardised packages, and audit-ready documentation. Submit an RFI today.