Protocol Templates

The below DAIDS templates should be consulted and used as appropriate when drafting protocol documents.

Protocol Registration Template

DAIDS Protocol Template Language for Protocol Registration
April 2010

Algorithm for Determining Whether Site Specific Informed Consent Forms will be Reviewed at the Time of Initial Protocol Registration

Expedited Adverse Event Reporting Section Template

DAIDS Protocol Template for Expedited Adverse Event Reporting
Version 5.0 - December 2015
*All protocols submitted for CSRC or PSRC review on or after March 1, 2016 must use this template.

DAIDS Therapeutic Research Program Guidance for the Development of Protocol Procedures to Address Reproductive Risk

DAIDS Therapeutic Research Program Guidance for the Development of Protocol Procedures to Address Reproductive Risk
December 2017

DAIDS Letter of Amendment Template   

DAIDS Letter of Amendment Template
April 2010

Informed Consent Documents

DAIDS Protocol Specific Informed Consent Template – General Use
Version 2.0 - December 2017

Instructions Page for the DAIDS Protocol Specific Informed Consent Template – General Use
Version 1.0 - February 2016

DAIDS Sample Informed Consent Template – Stored Samples for Future Use
Version 1.0 - February 2016

Instructions Page for the DAIDS Sample Informed Consent Template – Stored Samples for Future Use
Version 1.0 - February 2016

21 CFR 50.25(c) 

When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act.

The statement is: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

For the complete statutory definitions and more detailed information on NIH's current thinking on FDAAA, please visit:

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

Content last reviewed on 
August 1, 2018