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Division of AIDS (DAIDS) Clinical 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)

Protocol Registration Policy (PDF)

Protocol Registration Algorithm (PDF)

Protocol Registration Manual (PDF)

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

Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training Requirements (PDF)

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

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

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

Requirements for Clinical Quality Management Plans (PDF)

Storage and Retention of Clinical Research Records (PDF)

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Last Updated April 30, 2015