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.
Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.