Notice Number: NOT-OD-19-092

Key Dates
Release Date: March 26, 2019

NOT-OD-18-167
NOT-OD-17-064
NOT-HD-19-012
NOT-DA-23-033

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) has released a clinical trial protocol template with instructional and example text for NIH funded investigators to use in writing protocols for behavioral and social sciences clinical trials. This template was developed in response to changes in NIH policies that expanded the requirements associated with clinical trials beyond FDA-regulated clinical trials to those studies including behavioral or social interventions. Use of the template is recommended, but not required.

The protocol template is an effective resource for communicating the science, methods, and operations of a clinical trial, to guide training and accountability of study staff, to allow for efficient review by peers and oversight bodies, and to ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines, and to guide replication studies. The protocol template was also created to guide investigators through the systemic development of a comprehensive clinical protocol. This will be especially helpful for investigators less familiar with the information and level of detail expected in a clinical protocol. The template is a suggested format for clinical trials that are testing a behavioral or social intervention, and for which a stand-alone clinical protocol is required. However, for those trials funded by ICs that do not require stand-alone clinical protocols, this template can still be a useful tool for anticipating decision-points and potential challenges before a study launches.

In addition, the template has been fully integrated into NIH's Clinical E-Protocol Writing Tool. This tool allows for investigators to collaboratively author protocols that can be submitted to clinicaltrials.gov and/or the NIH IC(s) funding the trial. The E-Protocol Writing Tool can be accessed at: https://e-protocol.od.nih.gov

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy
SciencePolicy@od.nih.gov