For questions regarding specific policies or standard procedures, contact the DAIDS Policy Group.
Policies and procedures are essential to any clinical research enterprise. In this regard, DAIDS has standardized and harmonized operational procedures across research. Accordingly, all human subjects 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 the division’s 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 SOPs during monitoring visits.
Public Comment Sought On DAIDS Draft Clinical Quality Management Plan (CQMP) Policy Documents
The Division of AIDS is soliciting comments on the draft Clinical Quality Management Plan (CQMP) Policy, Protocol Regulatory File Tool and Chart Review Tool:
Clinical Quality Management Plan (CQMP) Policy (PDF)Protocol Regulatory File Tool (PDF)Chart Review Tool (PDF)
The finalized and OMB-approved Clinical Research Site (CRS) Quality Assurance (QA) Summary Report (PDF), which is part of the CQMP package, is posted as a courtesy. Comments will not be accepted for this document.
These draft documents describe the minimum requirements for the development, implementation, and evaluation of a Clinical Quality Management Plan (CQMP) at National Institute of Allergy and Infectious Disease (NIAID) Division of AIDS (DAIDS)-supported and/or -sponsored clinical research sites.
Please submit any comments to ProPEP Comment Coordinator. Include with your comments: the name of the document, and line number(s) and or section number that correspond to your comments.
This comment period will be open until Friday, November 28, 2014.
Links to policies and standard procedures relating to the reporting and monitoring of study progress and safety in DAIDS-funded and/or -sponsored clinical trials.
Links to policies and standard procedures relating to requirements for laboratories associated with DAIDS-funded and/or -sponsored clinical trials.
Links to policies and standard procedures relating to requirements for pharmacies associated with DAIDS-funded and/or -sponsored clinical trials.
Links to policies and standard procedures relating to the content of protocol and informed consent documents for DAIDS-funded and/or -sponsored clinical research
Links to policies and standard procedures relating to site operations, monitoring, quality management, and training at clinical research sites conducting DAIDS-funded and/or -sponsored clinical research.
(Currently under revision)Definitions of clinical research terms used by DAIDS.
These documents are accessible to the public for reference purposes and should not be regarded as reflecting current U.S. Department of Health and Human Services or DAIDS policy.
A list of Frequently Asked Questions (FAQs) and DAIDS responses.
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Last Updated April 09, 2014