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Protocol Templates for Clinical Trials


NIH applicants can use a template with instructional and sample text to help write 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
The NIH offers a secure web-based e-Protocol Writing Tool that allows you to generate new protocols for NIH-FDA Phase 2 and 3 IND/IDE and Behavioral and Social Science Research Involving Humans

Benefits of the e-Protocol Writing Tool include​:​
  • enables participation for multiple writers and reviewers
  • allows assignments for writers and collaborators
  • tracks progress and ensure document version control
Note: The use of these templates is recommended, but not required.

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
  • 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
This page last updated on April 15, 2019
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