Office for Policy in Clinical Research Operations (OPCRO)
The DAIDS Office for Policy in Clinical Research Operations (OPCRO) manages and supports the DAIDS clinical research and helps ensure compliance with applicable regulations, standards, and good clinical practice guidelines; study participant safety and welfare; and study quality and integrity. OPCRO, which includes the Clinical Research Resources Branch, Human Subjects Protection Branch, Policy, Training, and Quality Assurance Branch, Regulatory Affairs Branch, Pharmaceutical Affairs Branch; Clinical Trials Agreements Team, and Safety and Pharmacovigilance Team, carries out the following key functions:
- Develops and maintains Division-wide clinical research polices and standard procedures and coordinates related training and quality assurance activities
- Manages a portfolio of DAIDS contracts for independent site monitoring
- Implements the DAIDS safety monitoring and reporting, related safety standards, and pharmacovigilance capacity
- Manages Investigational New Drug Applications
- Provides pharmaceutical expertise
- Develops Clinical Trial Agreements
- Protects the rights and well-being of clinical research subjects
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