Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

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.

Related Topics:

Event Reporting and Safety Monitoring
Protocol and Informed Consent Development

Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials (PDF)

• Appendix 1 - Essential Documents Recordkeeping Requirements (PDF)

Protocol Registration Policy (PDF)

• Appendix 1 - Protocol Registration Algorithm (PDF)
• Appendix 2 - Protocol Registration Manual (PDF)

Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements (PDF)

Requirements for Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training for Clinical Research Site Personnel (PDF)

Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials (PDF)

• Appendix 1 - Source Documentation Requirements (PDF)

Requirements for Manual of Operational Procedures (MOP) (PDF)

• Appendix 1 - Required Site SOPs (PDF)
• Appendix 2 - Sample Table of Contents (PDF)

Requirements for On-Site Monitoring of DAIDS Funded and/or Sponsored Clinical Trials (PDF)

Requirements for Clinical Quality Management Plans (PDF)

• Appendix 1 - Sample Clinical Quality Management Plan (CQMP) [CL.205] (PDF)
• Appendix 2 - Sample Clinical Quality Management Chart Review Tool [CL.206] (PDF)
• Appendix 3 - Sample Clinical Quality Management Regulatory File Review Tool [CL.207] (PDF)
• Appendix 4 - Sample Clinical Quality Management Summary of Activities Tool [CL.208] (PDF)
• Appendix 5 - Sample Clinical Quality Management Plan Annual Summary Report [CL.209] (PDF)

Storage and Retention of Clinical Research Records (PDF)

• Appendix 1 - Record Retention Flow chart CL-201 (PDF)
• Appendix 2 - TEXT ONLY-Record retention Flow Chart CL-201A (PDF)

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