An official website of the United States governmentRequired Templates
Access study document templates required in the NCCIH clinical study review process.
Required Protocol Templates
| NCCIH Protocol Template [80KB Word file] | Recommended Protocol Template for NCCIH-funded clinical studies |
| Protocol Template for Behavioral & Science Research [377KB Word file] | Optional Clinical Trial Template for Behavioral and Social Sciences Interventions |
| NIH-FDA Phase 2 and 3 Protocol Template [356KB Word file] | Optional IND/IDE Clinical Trial Protocol Template |
Other Required Templates
| Data & Safety Monitoring Plan (DSMP) Independent Monitoring Plan Template [123KB Word file] | Provides a recommended structure for a data and safety monitoring plan. Includes example text, instruction, and sample data tables, as well as a report template. |
| Electronic SARP Template (60KB Word file) | Includes sample text and instructions. |