Clinical Site

Site Requirements for Children (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)

Appendice(s):

• Source Documentation Requirements (PDF)

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

Appendice(s): 

• 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)

Appendice(s):

• 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), (MS Word)
• 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)

Appendice(s):

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

Frequently Asked Questions (PDF)

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