Clinical Research Units

What is a CRU?

A Clinical Research Unit (CRU) is an organizational structure within UC San Diego Health Sciences that supports the conduct, management, and oversight of clinical research involving human participants. CRUs are expected to provide the infrastructure necessary to ensure high-quality, ethical, and compliant clinical research, in collaboration with the Office of Clinical Research (OCR). See criteria to define a CRU (pdf).

CRU Models

Researchers may align within a CRU through one of the following models:

Join an existing large CRU, such as the Moores Cancer Center CRU or the Altman Clinical and Translational Research Institute (ACTRI) Center for Clinical Research (CCR)
Establish an investigator-initiated CRU
Create a Department (or in rare cases, Divisional) CRU

Minimal required infrastructure

A CRU must meet the following criteria:

> 10 Faculty investigators with at least 5 serving as PI/PD on clinical research studies
>50 new participant enrollments per year*
Sustainable revenue to support CRU operations

*Exceptions may apply, such as rare disease studies or studies conducted at the VA Medical Center and Rady Children's Hospital

Steps to Establish a CRU

Internal planning: Meet with faculty, research directors and administrative staff to define objectives and review CRU requirements
Contact OCR: Initiate the CRU development process by providing an organizational chart and standard operating procedures (SOPs) for the "core" list of SOPs designated on the OCR SOP webpage. CRUs may adopt the OCR SOPs from the library or demonstrate that the content of existing SOPs align with those in the OCR SOP library.
Assessment & Implementation: Work with OCR to assess the team, assign responsibilities and identify an implementation plan. Optional access to central technology resources is available.
Agreement on reporting metrics: Review CRU performance metrics and reporting schedules with OCR

OCR Support and Resources for CRU

OCR will provide 0.5 FTE Administrative Director for 6 months to assist with CRU activation, SOP harmonization, and implementation of optional technology tools (e.g., Harvest, Monday) to improve efficiency and process transparency (i.e., study activation times).
Future support will be evaluated based on needs (i.e., financial dashboards, staff training, shared research personnel).

CRU Reporting and Compliance Metrics

CRU directors will report to:

OCR director for processes, policies, safety, compliance, and efficiency
Department Chair/Center Director for academic priorities, funding, and research direction
Key CRU Metrics:
- Number of active clinical research studies
- Study activation and gap analysis (i.e., needs of the CRU)
- Study activation times
- Compliance with participant registration requirements (UCSDHP 340.1 policy)
- Notice (and outcomes) of local or sponsor-initiated audits