Data and Safety Monitoring in Human Subjects Research
Describes approaches to monitoring the emerging results of an ongoing study, the different types of study data that are monitored, and the role and operational procedures of independent monitoring groups and how they relate to other study oversight entities. It also explains regulatory requirements and other policies related to study monitoring and discusses similarities and differences between the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB). Reviews the basic elements of data safety monitoring plans and DSMBs.
This module was created in collaboration with PRIM&R. Please see PRIM&R's website for their DSMB webinar, a continuation of the content covered in this module.
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