Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents
The Division of AIDS is now soliciting comments from grantees and others involved in DAIDS Clinical Research on the following new DRAFT policy and manual:
Identification and Classification of Critical Events: Site Responsibilities (PDF)
DAIDS Critical Events Manual (PDF)
About the Clinical Research Policies and Standard Procedures Documents
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.
Links to policies and standard procedures relating to the management and analysis of data in DAIDS funded and/or sponsored clinical trials.
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.
Links to policies and standard procedures for determination of Investigational New Drug Applications, maintenance of essential documents files, and protocol registration for DAIDS funded and/or sponsored clinical research.
(Currently under revision)
Definitions of clinical research terms used by DAIDS.
A list of Frequently Asked Questions (FAQs) and DAIDS responses.
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