Clinical Research Billing Compliance Office
Our mission is to provide oversight, education and ongoing support to all areas of OHSU involved in clinical research billing to facilitate compliance with all relevant laws, regulations and policies.
The OHSU Clinical Research Billing Compliance Office was established to:
- Develop internal policies, procedures and processes related to clinical research billing at OHSU.
- Provide ongoing education, tools and support to all areas of OHSU involved in clinical research billing.
- Provide oversight and monitoring for compliance with policies and procedures related to clinical research billing.
- Perform prospective reimbursement analyses for all clinical research studies.
Outside Requests for Information - Several departments have reported requests from outside entities to provide identifiable research subject information relating to subject injury reporting or clinical research billing. Any requests from outside entities for identifiable research subject information outside of the data required by the protocol to be collected and forwarded to the sponsor should be forwarded to the This includes requests from study sponsors, their contractors, and third-party payers. The CRBO will review and respond, or forward the request to the appropriate party to respond.
**All research subjects receiving clinical services as part of a study are required to be identified in Epic as being "associated" with that study**
Studies that are in eCRIS will have research associations automatically added to Epic when study staff add a consented subject into eCRIS.
The research association will be made inactive in Epic once the study team transitions the subject to Off Study in eCRIS. The study teams will no longer need to fill out the Research Subject Study Status Change form. If they have a subject needing a Preconsent added into Epic, they will fill out the Research Subject Preconsent Study Status form, so that an Epic research encounter can then be scheduled. The preconsent requests need to be sent to the Research Indicator inbox.
Proceed to Identifying Research Subjects on the Epic and Research Subjects page for more information.