Requirements

Copy of all Data Safety Monitoring Board (DSMB) reports

Additional correspondences with DSMB (e.g. meeting minutes, information provided to the DSMB, emails)

QIU 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: 

• HRPP Guidance
• NIH Guidance
• FDA Guidance
• DSMP Checklist

Applicable GCP sections: 

• 8.3.10
• 5.19.3