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Evaluation and Policy Branch (ProPEP), has developed this central policy archive site to store all historical, outdated, and superseded policy documents.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

• Expedited Adverse Event Reporting Policy

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
  • Appendix 1 - Risk/Benefits Categories
  • Appendix 2 - Examples of Templated Language
  • Appendix 3 - Wards
  • Appendix 4 - Waivers of Parental/Guardian Permissions or Child Assent
• Requirements for Protocol Documents for DAIDS Funded and/or Sponsored Clinical Trials
  • Appendix 1 - DAIDS Guidance for Protocol Documents
• 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