About
Introduction
A robust set of policies and procedures is essential to a clinical research enterprise. In this regard, the Division of AIDS (DAIDS) has recently standardized and updated our Clinical Research Policies and Standard Procedures. Accordingly, all human subjects research funded and/or sponsored by DAIDS must be compliant with these policies and standard procedures in addition to the NIAID Clinical Terms of Award and all NIH clinical research policies.
Status of DAIDS Policies and Standard Procedures Documents
DAIDS has collated the comments received from its networks and other stakeholders and made appropriate revisions to finalize the documents. The versions now posted are final.
Compliance
By June 1, 2008, DAIDS may, at its discretion, request the Clinical Site Monitoring Group (CSMG) monitors to spot-check training documentation for compliance during monitoring visits. Also, appropriate HSP/GCP training documentation for key personnel will be submitted with progress reports for review by the Program Officer.
Scope
The applicability of each policy and standard procedure to different types of research (i.e., human subjects research or clinical trial) is outlined in the document’s statement of Scope and is listed in the Table of Research Applicability.
More Information
For questions regarding specific policies and standard procedures, contact the DAIDS Policy Group.