The CTSA Collaborative Data and Safety Monitoring Board (DSMB) Workgroup identified a need to provide guidance, training, and resources in DSMB practices for investigator-initiated research studies. To promote clinical and translational research, the CTSA Collaborative DSMB Workgroup, supported by the National Center for Advancing Translational Science, or NCATS, has produced an online DSMB Training Manual with a focus on investigator-initiated studies. This manual provides information and training for principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs.
More information is on the Johns Hopkins Institute for Clinical and Translational Research website.