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
- enables participation for multiple writers and reviewers
- allows assignments for writers and collaborators
- tracks progress and ensure document version control
Word TemplatesWord 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.
|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|