Data Safety Monitoring Plan & Data Safety Monitoring Board Coordination
A data and safety monitoring plan describes how the study will be overseen for subject safety and data integrity. Specific activities in a DSMP are determined by the complexity and risk of the study. OCTRI staff can help to draft DSMPs for grants, protocols, and Institutional Review Board (IRB) submissions.
A data and safety monitoring board (DSMB) is a group of individuals charged with oversight of the safety of subjects and data integrity in a study. OCTRI staff members can help investigators determine if their study needs a DSMB.
- Developing a charter
- DSMB consultation