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Protocol Templates

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

Protocol Registration Template

Expedited Adverse Event Reporting Section Template

Word 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 Template for Pregnancy Prevention

DAIDS Letter of Amendment Template   

Informed Consent Documents

    Doc_Icon_WebLink 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:

    PDF

    Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

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This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).