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Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

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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