Clinical Research Finance Assessment (CRFA)
Background
The UCI Health System has established the Office of Clinical Research Finance Assessment (CRFA) in an effort to fulfill regulatory requirements from the federal Office of the Inspector General, the University of California Corporate Compliance Program, and the Joint Commission on Accreditation of Healthcare Organizations. The CRFA is responsible for ensuring proper registration and billing practices for all human subjects receiving clinical care while enrolled on clinical research studies.
Requirements
CRFA approval is required before study procedures can be initiated. While applications submitted to the IRB will be reviewed without first obtaining clearance or approval from the CRFA. It is strongly recommended that CRFA approval be obtained before submission to the IRB to prevent further delays. For example, if CRFA requires changes to the informed consent document, a modification request must be submitted for IRB approval before any study procedures can be initiated. Moreover, the IRB can on a protocol-by-protocol basis require CRFA approval prior to granting IRB approval.
Staff from the CRFA assists clinical investigators to ensure proposal submissions are tracked through approval by the Department Chair, School of Medicine Dean, Sponsored Projects Administration and Institutional Review Board. The purpose of tracking the study proposal is to ensure that the award/grant funding has been established and a funding source identified for the study and that the protocol and informed consent document are approved prior to human subject enrollment.
The billing risk for clinical research studies is assessed and plan codes are assigned to establish appropriate billing practices. Standardized costing information is available to investigators for technical and professional services on federal and privately sponsored studies for protocol-related clinical services. This information is available to all UCI Health Sciences users on a secured access website.
All human subjects are registered in the hospital registration system and registration activities are coordinated through the encounter process with registration training and support provided to key research staff during the study period.
Additional Information about the CRFA
All questions concerning CRFA submission and review or subject billing should be directed to the CRFA Office:
Paula Hilbert, R.N.
Clinical Research Cost Analyst
(714) 456-3922
Email: philbert@uci.edu
For detailed information about the CRFA review process, please visit the CRFA website.
Note: this website is located on the UCIMC Intranet, which requires HSIS intranet access. All School of Medicine employees have access to the HSIS intranet.
If you do not have HSIS intranet access, please contact one of the CRFA staff for instructions on how to submit for CRFA review.
