Division of AIDS (DAIDS) Clinical Site Implementation and Operations

This section provides links to policies and standard procedures related to the implementation, monitoring, quality management, and training at clinical research sites conducting DAIDS-supported and/or -sponsored clinical research.

• Requirements for Essential Documents
  • Appendix 1 - Essential Documents Recordkeeping Requirements
• Protocol Registration Policy
• Protocol Registration Algorithm
• Protocol Registration Manual
• Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements
• Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training Requirements
• Requirements for Source Documentation
  • Appendix 1 - Source Documentation Requirements
• Requirements for Manual of Operational Procedures (MOP)
  • Appendix 1 - Required Site SOPs
  • Appendix 2 - Sample Table of Contents
• Requirements for On-Site Monitoring
• Requirements for Clinical Quality Management Plans
  • Appendix 1 - Clinical Quality Management Plan (CQMP): Sample QA Participant CHART Review Tool
  • Appendix 2 - Clinical Quality Management Plan (CQMP): Sample QA Protocol Regulatory File Review Tool
  • Appendix 3 - Clinical Research Site (CRS) Quality Assurance (QA) Summary Report
  • CQMP Summary Reference Document
• Storage and Retention of Clinical Research Records
  • Appendix 1 - Record Retention Flow chart CL-201
  • Appendix 2 - TEXT ONLY-Record retention Flow Chart CL-201A

Related Topics

• Event Reporting and Safety Monitoring
• Protocol and Informed Consent Development