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Evaluation and Policy Branch (ProPEP), has developed this central policy archive site to store all historical, outdated, and superseded policy documents.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
- Access to Archived Specimens and Data from Completed Study: Women and Infants Transmission Study (WITS)
- Destruction of Clinical Research Specimens Owned by NIAID
Pharmacy and Study Products Management
- Requirements for Pharmacy Facilities at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks
- Requirements for Pharmacy Activities at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks
- Requirements for Pharmacy Personnel at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks
Protocol and Informed Consent Development
- Enrolling Children (including Adolescents) in Clinical Research: Protocol Document Requirements
- Requirements for Protocol Documents for DAIDS Funded and/or Sponsored Clinical Trials
- Use of Study Products Not Marketed in the United States Policy
Site Implementation and Operations
- Protocol Registration Policy
- Protocol Registration Manual
- Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements
- Requirements for Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training for Clinical Research Site Personnel
- Requirements for On-Site Monitoring of DAIDS Funded and/or Sponsored Clinical Trials
Requirements for Clinical Quality Management Plans
- Appendix 1 - Sample Clinical Quality Management Plan (CQMP) [CL.205]
- Appendix 2 - Sample Clinical Quality Management Chart Review Tool [CL.206]
- Appendix 3 - Sample Clinical Quality Management Regulatory File Review Tool [CL.207]
- Appendix 4 - Sample Clinical Quality Management Summary of Activities Tool [CL.208]
- Appendix 5 - Sample Clinical Quality Management Plan Annual Summary Report [CL.209]
Storage and Retention of Clinical Research Records
Content last reviewed on October 18, 2016