Clinical Research Units
Clinical Research Units (CRU) are expected to have the infrastructure to support a strong foundation for the conduct of high-quality, ethical, and compliant clinical research, enabled by partnering with the Office of Clinical Research (OCR). The partnership between OCR and the CRU will encourage collaboration with leaders across the Health Sciences' clinical research enterprise to ensure efficient and high-quality clinical research, equitable access to groundbreaking therapies, and a diverse community of scholars. Establishment of a CRU is formalized by a memorandum of understanding between the OCR and the CRU director.
The OCR advisory committee has established the criteria for a CRU (PDF) , which include the following:
- Qualified Personnel
- Infrastructure and Facilities
- Participant Registration
- Standard Operating Procedures
- Data Management and IT Systems
- Quality Assurance and Monitoring
- Financial Management
- Patient Recruitment and Retention Strategies
- Continuous Education and Training
- Publication and Dissemination Plans
CRUs will demonstrate ongoing adherence to these criteria by providing, for example, quarterly, for the first year, and then annual CRU compliance summary reports that include the following metrics:
- Number of active clinical research studies
- CRU assessment of staffing
- Gap analysis (i.e., needs of the CRU)
- Study activation times
- Compliance with participant registration requirements (UCSDHP 340.1 policy)
- Local and/or sponsor-initiated audits
New CRUs
ID-GPH becomes the first CRU
The Division of Infectious Diseases-Global Public Health met the requirements to become the first UC San Diego Health Sciences CRU in December 2024.