In our previous posts in this series, we’ve been looking at changes in the updated BIMO Compliance Program Manual for Sponsors and CROs. Today we look at a section that is completely new since the previous version: Data and Safety Monitoring Board/Data Monitoring Committee.
This section is fairly short and covers the documents you would expect an inspector to review: namely, the charter and meeting minutes. Naturally, there is a focus on unblinded data and communication of decisions to the sponsor. It is quite process-focused: it directs the inspector to determine how members were selected, whether the process outlined in the charter was followed, and how conflicts of interests were managed. The latter process is of significant concern to companies working in rare diseases, where it may be difficult to find DSMB members who are wholly independent of the sponsor.
The manual also asks inspectors to “confirm that all members receive required training.” This may be a bit of a stumbling block for sponsors and DSMB managers who do not typically outline required training or formally document training on the charter or protocol.
Most sponsors prepare a storyboard or two about DSMB operations during inspection preparation. The update to this manual provides us with some directed questions to include in our preparations.