Data Safety Monitoring Board Reports
Copy of all Data Safety Monitoring Board (DSMB) reports
Additional correspondences with DSMB (e.g. meeting minutes, information provided to the DSMB, emails)
Tips / Additional Information
Submit a copy of the most recent DSMB report to the IRB at the time of continuing review.
Refer to the HUB for Data and Safety Monitoring guidance and templates to assist sites in developing a monitoring plan to ensure subject safety and data integrity:
Applicable GCP sections: