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
- 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
- Requirements for Manual of Operational Procedures (MOP)
- 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
Related Topics
Content last reviewed on December 15, 2016