Clinical Trials Protocol Templates

The creation of the NIAID Clinical Trial protocol templates was approved by the Executive Committee in 2006. The goal of the templates is to provide a standardized template to assist NIAID investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. The use of these templates is not mandatory but highly recommended.

Protocol Template Guidance (PDF)
To provide a standardized template to assist NIAID investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. 

Intramural Clinical Trials Protocol Template
For comments or assistance with the intramural template set, please contact Heather Bridge (Contractor) at bridgeh@mail.nih.gov.

Instructions for using the Intramural Templates (PDF) 
Blank Template [for experienced investigators] (Microsoft Word)
Template with Suggested Language (Microsoft Word)
Version 2.0 List of Revisions (PDF)

Intramural Natural History Protocol Template
For comments or assistance with the intramural template set, please contact Heather Bridge at bridgeh@mail.nih.gov.

Instructions Manual Version 1.0 (PDF)
Blank Template Version 1.0 [for experienced investigators] (Microsoft Word)
Suggested Language Template Version 1.0 (Microsoft Word) 

Extramural Clinical Trials Protocol Template
For comments or assistance with the extramural template set, please contact Mary Smolskis at msmolskis@niaid.nih.gov.

Blank Template (Microsoft Word)
Template with Instructions (PDF) | Microsoft Word