NIH Staff 
NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research:
- Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications
- Behavioral and social sciences research involving humans
Benefits of the e-Protocol Writing Tool include:
The following templates provide a common protocol structure and organization which can facilitate protocol review by oversight entities.
- enables participation for multiple writers and reviewers
- allows assignments for writers and collaborators
- tracks progress and ensure document version control
Word Templates
Word versions of the protocol templates can also be downloaded for use outside of the e-protocol Writing Tool.The following templates provide a common protocol structure and organization which can facilitate protocol review by oversight entities.
| Protocol | Description | Word Template |
| Phase 2 and 3 Clinical Trials that Require FDA-IND or IDE Application | This protocol template aims to facilitate the development of two types of clinical trials involving human participants. The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. | IND/IDE Protocol Word Template |
| Behavioral and Social Science Research (BSSR) Involving Humans | NIH developed a second protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention. | BSSR Protocol Word Template |
Related Notices
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NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
- NOT-OD-19-092 NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans
