Division of AIDS Clinical Research Policies and Standard Procedures Documents

Note: The information on NIAID’s investigator-initiated clinical trial (IICT) pages is being updated. Refer to the scientific/research contacts listed in our IICT funding opportunity announcements if you have any questions.

Policies and procedures are essential to any clinical research enterprise. In this regard, the Division of AIDS (DAIDS) has standardized and harmonized operational procedures across research. Accordingly, all human subjects research supported and/or sponsored by NIAID must be compliant with these policies and standard operating procedures in addition to the NIAID Clinical Terms of Award; all National Institutes of Health (NIH) clinical research policies; and 45 CFR 46, subparts B-D. These documents also serve as resources for DAIDS collaborators and staff to refer for division requirements on the conduct of DAIDS research.

The applicability of each policy and standard operating procedure to different types of human subject research (i.e., clinical research, observational research, or clinical trials) is outlined in the document’s statement of Scope.

DAIDS expects compliance with all applicable policies and procedures within 30 days of the “effective date” stated on each document. DAIDS may, at its discretion, request the Clinical Site Monitoring Group (CSMG) monitors to spot-check documentation for compliance to these policies and standard operating procedures during monitoring visits.

Please note that as DAIDS policy documents undergo revisions, they will be updated using the new DAIDS document numbering convention and format. As documents are transferred to the DAIDS Quality Management System, the version numbering will begin with version 00 to mark the first version with the new quality system. However, the prior versions in the old system are archived and the change history of the document is captured within the document.  This change will be effective beginning February 1, 2019.

DAIDS Policy Table of Contents

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