Notice

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

Updates regarding government operating status and resumption of normal operations can be found at USA.gov.

Division of AIDS (DAIDS) Clinical Research Policy Archive

DAIDS, Protection of Participants, Evaluation and Policy Branch (ProPEP), has developed this central policy archive site to store all historical, outdated, and superseded policy documents. The documents available in PDF format, are made accessible to the public for reference and informational purposes only. These documents should not be regarded as reflecting current U.S. Department of Health and Human Services or DAIDS policy and are not appropriate for providing current guidance. To view more current DAIDS clinical research policies, please see DAIDS Clinical Research Policies and Standard Procedures Documents.

Clinical Research Event Reporting and Safety Monitoring

Laboratory and Specimens Management

Pharmacy and Study Products Management

Protocol and Informed Consent Development

Site Implementation and Operations

Requirements for Clinical Quality Management Plans

Storage and Retention of Clinical Research Records

Content last reviewed on October 18, 2016