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Required 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.