Protocol Registration Forms

Form FDA 1572: Statement of Investigator
FDA required document in which clinical investigators agree to conduct the clinical trials according to U.S. Federal regulations. The Form FDA 1572 is signed by the investigator and a copy is submitted to the IND Sponsor.

DAIDS Investigator of Record (IoR) Form
A form required by DAIDS for non-IND studies that are sponsored and/or supported by DAIDS. By signing the document, the IoR affirms that he/she will conduct the clinical trial according to applicable U.S. Federal regulations, local laws, DAIDS requirements and DAIDS policies.

Translation Confirmation Document
May 2015
For all documents that require translation to a language other than Spanish, a CRS must submit to the DAIDS RSC PRO a copy of the DAIDS Protocol Registration Translation Confirmation Document, attesting that the translation is a true and accurate reflection of the local language documents that have been reviewed and approved by the IRB/EC and other REs/Approving Entities.

Protocol Registration Checklist
This document must be submitted with each submission made through the electronic protocol registration (EPR) mailbox to the DAIDS RSC PRO.

Alternate format(s) available:

DAIDS Clinical Trial Application Submission Checklist 
Version 1.0 – November 2018
This document must be submitted with each Clinical Trial Application submission to the DAIDS RSC PRO.


Note: DAIDS Financial Disclosure Forms can be found here.

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