OHSP Feedback Form
Guidance on Monitoring Clinical Trials
All clinical trials require safety monitoring. You may be required to submit a data safety-monitoring plan to an IRB, a NIH funding institute or an industry sponsor.
The following links contain useful information regarding clinical trial safety monitoring:
Regulations:
- NIH Policy for data and safety monitoring
- Further Guidance on a data and safety monitoring for phase I and phase II trials
Guidance documents:
- RSRB Guideline
- Guidance for Clinical Trial Sponsors (PDF)
- Support for registration of clinical trials policy