OFFICE OF CLINICAL RESEARCH ADMINISTRATION (OCRA)
Welcome to the Office of Clinical Research Administration (OCRA) website. OCRA was established by the New Jersey Medical School and University Hospital to centralize and manage all clinical research operations, resources and oversight for NJMS/UH faculty and staff. As OCRA grows over the next year, so will the content and resources available on this website.
Scroll over the OCRA tab to the left to view the drop-down for: Chart Review, Study Initiation and Subject Registration.
Each time you plan to initiate or modify a study, please refer to the below UPDATES for the most current versions of OCRA forms. Forms change frequently so please check each time you initiate or modify a study:
Current Feasibility Form Version: V8 (as of 4/25/11)
Current bSOE Version: V8 (as of 4/25/11)
Chart Review Registration Form Version: V8 (as of 4/25/11)
Subject Registration Form Version: V8 (as of 4/25/11)
We welcome your feedback regarding this website, our goal is improve communication, consistency and collaboration across the clinical research community and the entities that serve it.
The OCRA offices are located in the Cancer Center at 205 South Orange Ave., F-1230 & 1240.
Cynthia Hayes-Sanders, MS
Research Billing Compliance Analyst
Quick Links for Faculty and Staff
- Feasibility Form: document that is used to determine feasibility for conducting a clinical research study at UH/NJMS. It helps establish clinical research billing compliance and status as a Qualifying Trial. Completion & submission of this document to OCRA (see above) is mandatory prior to further review by Legal, ORSP & Grants & Contracts.
- Budgeted Schedule of Events (bSOE): is a tool that combines a calendar of events, items & services and costs to establish a budgeted billing plan. The bSOE delineates pure research from routine care in clinical research, which is vital to compliant clinical research billing (see below).
- Pure Research: services performed solely for research on normal volunteers, control subjects and patients who would not otherwise be hospitalized or receive ambulatory items or services except for their participation in this research study. All associated costs are the responsibility of the PI through sponsor, department or other funds (industry, grants etc).
- Routine Care in Clinical Research: services performed as part of the established or usual standards of care of the patient. Results from these services are used for research purposes as approved in the IRB protocol & identified in the Budgeted Schedule of Events. All associated costs are responsibility of the third party payor or patient as described in the study consent form.
- Standard of Care: conventional care given to patients entirely unrelated to a clinical trial.