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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
Templates:
The following templates are from the University of California at San Francisco. You may find them useful if you are required to develop a safety-monitoring plan.
- Single Center Clinical Trial
- Multi - Center Clinical Trial
- Single Center FDA Clinical Trial
- Multi - Center FDA Clinical Trial
- Single Center Gene Therapy Clinical Trial
- Multi - Center Gene Therapy Clinical Trial
The University of California site also has NIH institute specific requirement information which can be found at: