The OCR’s Research Compliance Support Program

The Office of Clinical Research (OCR) partners with a variety of UC and UC Health research and compliance departments to promote and support ethical and safe research practices for both institutions and the UC/UCH research community and participants.

Policy, SOP, and Workflows

With the recent move to UC, SOPs and workflows are being developed as much of the clinical research operations and processes are still being determined. As these resources are developed, they will be accessible from this page.

UCH policies and SOPs are still current and ask that the UC/UCH research community continue to review them regularly. As processes change, new guidelines will be written, or the current ones will be updated. Any work done within UCH facilities will fall under the current polices.UCH Polices and SOPs can be accessed through the UCH Intranet.

Research Billing and Coverage Analysis

The OCR works closely with UCH Billing Compliance, Billing and Revenue Cycle teams and the study teams to ensure appropriate billing. The daily research encounters billed in Epic are defined through a Coverage Analysis for qualified research studies. Continual evaluation of billing practices occur through several committees and continual collaborative review to ensure best practice in Epic.

HIPAA Review/ICF Edits

As HIPAA language is UCH required language, the OCR assists the Privacy Office in reviewing any edits to the UCH language used in clinical trial Informed Consents. Please send EDITED HIPAA language only to Maria Stivers for review and approval.

MIDAS and Adverse Event Monitoring

The OCR reviews all Reportable New Information submitted to the UC IRB. The OCR also reviews research related events reported in the UC Health incident reporting system MIDAS. Link to the UC Health intranet portal: UC Health Intranet Midas Link. An OCR standard operating procedure on the types of events (Unexpected and related) to report in MIDAS for institutional patient safety initiatives, can be found on Compliance 360. The OCR follows up on MIDAS adverse events that require further action.

Research Approvals

UC Health has a research approval process in place to ensure that all studies have the necessary support required for safe, quality research and to ensure UCH oversight of research occurring within the institution. Ancillary services are asked to review the research to ensure it can be managed and resources are available. Research cannot begin until UCH Research approval occurs.

Research Access/Credentialing

Anyone requesting access to UCH facilities, patients or the electronic medical record (Epic) for research purposes, is required to submit a Research Access Application for access. The approval process can include establishing a UCH employee ID, background check, Epic and MyKnowledge training and a visit to UCH Employee Health.