Compliance with DAIDS policy: Requirements for Human Subect Protection (HSP) and Good Clinical Practice (GCP) Training for Clinical Research Site Personnel
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.
A list of Frequently Asked Questions (FAQs) and DAIDS responses is now available. |
Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents
This section contains the final versions of policies and standard procedures for conducting DAIDS funded and/or sponsored clinical research.
Information addressing the scope and effective dates for the policies and standard procedures and how to obtain additional information.
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 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 for determination of Investigational New Drug Applications, maintenance of essential documents files, and protocol registration for DAIDS funded and/or sponsored clinical research.
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 management and analysis of data in DAIDS funded and/or sponsored clinical trials.
(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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