Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Templates

Protocol Templates

Below are all of the NIH Protocol Templates. These templates should be used when writing a new NIH Intramural Program protocol. Please refer to specific pages under Protocol Development for more information about each template.

Protocol Templates and Guidance

Protocol templates for developing a variety of different new research protocols

Behavioral & Social Science Research Protocol Template
  • February 4, 2025
  • 211.4 KB

Protocol Template For Behavioral And Social Science Research

Interventional Drug and Device Clinical Trials Protocol Template
  • February 4, 2025
  • 239.8 KB

Protocol Template For Interventional Drug/Device Clinical Trials Only

Natural History and Observational Trials Protocol Template
  • February 4, 2025
  • 147.0 KB

Protocol Template For Natural History/Observational Trials

Related documents

NIH Protocol Addendum Template When NIH is the Reviewing IRB
  • February 4, 2025
  • 54.6 KB

NIH Protocol Addendum Template When NIH Is The Reviewing IRB

Prospective Data Collection Protocol Template
  • June 30, 2021
  • 85.5 KB

Protocol Template For Prospective Data Collection From Humans(Request For An Exemption)

pSITE Protocol Addendum Template
  • January 30, 2023
  • 67.2 KB

Repository Protocol Template
  • February 4, 2025
  • 98.1 KB

Protocol Template For Repositories Only

Retrospective Data or Biospecimen Review Protocol Template
  • June 30, 2021
  • 67.0 KB

Protocol Template For A Retrospective Data Or Biospecimen Review(Request For An Exemption)

Related documents

Secondary Research Protocol Template
  • February 4, 2025
  • 93.5 KB

Protocol Template For Secondary Research With Biospecimens, Data And/Or Medical Records Only