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.|