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 NCATS, has produced an online resource, the Data and Safety Monitoring Board Training Manual for 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.
CTSA Collaborative DSMB Workgroup
M.E. Blair Holbein
Barbara N. Hammack
Tasmin A. Knox