NIH Data Safety Monitoring Plan Information and Templates
To assist investigators in complying with the NIH data safety monitoring policy, please visit guidance and sample DSMP templates on the NIH website.
See also FDA and NIH Guidance. Various NIH Institutes may have their own DSMP guidelines.
Further guidance:
- NINDS Glossary of Clinical Research Terms
- NIH Policy for Data and Safety Monitoring
- Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
Need assistance or have clinical study management questions? Request a CTSI Study Design & Implementation Consultation