Clinical Site
Please note that the effective date for these finalized DAIDS Policies and Standard Procedures is February 5, 2007.
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):
Requirements for Manual of Operational Procedures (MOP) (PDF)
Appendice(s):
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)