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Protocol Templates for Clinical Trials

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
These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates
   
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
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 July 12, 2021
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