Division of AIDS (DAIDS)

Clinical Site

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

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

Appendices:

• Appendix 1 – Risk/Benefits Categories [CL.201] (PDF)
• Appendix 2 – Examples of Templated Language [CL.202] (PDF)
• Appendix 3 – Wards [CL.203] (PDF)
• Appendix 4 –Waivers of Parental/Guardian Permissions or Child Assent [CL.204] (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:

• Source Documentation Requirements (PDF)

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

Appendices: 

• Required Site SOPs (PDF)
• 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 at DAIDS Funded and/or Sponsored Clinical Research Sites (PDF)

Appendices:

• Sample Clinical Quality Management Plan (CQMP): (PDF), (MS Word)
• Sample Clinical Quality Management Chart Review Tool: (PDF), (MS Word)
• Sample Clinical Quality Management Regulatory File Review Tool: (PDF)
• Sample Clinical Quality Management Summary of Activities Tool: (PDF), (MS Word)
• Sample Clinical Quality Management Plan Annual Summary Report: (PDF), (MS Word)

Storage and Retention of Clinical Research Records (PDF)

Appendices:

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

Frequently Asked Questions for Storage and Retention of CRR (PDF)

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