Office of Clinical Research Administration

The NJMS Office of Clinical Research Administration (OCRA) helps to facilitate University Hospital review and approval of clinical research conducted by NJMS faculty. Please see the instructions below by study type.

 

NJMS-OCRA/University Hospital Requirements by Study Type:

Retrospective Chart Review/Secondary Research using UH-Newark’s medical records

E-mail the following documents to OCRAReview@njms.rutgers.edu

The NJMS-OCRA representative will provide you with an e-mail, copying the UH Office of Clinical Research Services, which acknowledges receipt of your documents. You may upload a copy of the e-mail to your eIRB application to provide proof of notification to UH.

Important: You are asked to forward a copy of your eIRB approval to the UH Office of Clinical Research Services at UH-CRS@uhnj.org upon receipt, so that your study can be forwarded for final UH approval.

Clinical Trials or non-interventional studies with billable clinical procedures

Effective September, 2021, studies meeting the criteria below fall under the purview of the RBHS Clinical Trials Office, and must be entered into the RBHS OnCore Enterprise Clinical Trial Management system:

  • RBHS Faculty member (outside of CINJ) as Principal Investigator
  • Meets the definition of a Clinical Trial (https://grants.nih.gov/policy/clinical-trials/definition.htm) or is a prospective observational or single time point study which entails/requires billable clinical procedures (i.e. procedures associated with a CPT code, such as a CT scan, MRI, clinical laboratory testing.)
  • Will be implemented locally at an RBHS location or partner hospital facility, including UH-Newark

Please contact the RBHS Clinical Trials Office for more information: clinicaltrials@rbhs.rutgers.edu

More information on these processes may be found at: https://njacts.rbhs.rutgers.edu/clinical-trials-office/oncore/

 

Studies which do not meet the definitions listed above, but which involve University Hospital-Newark patients or facilities

Examples include survey studies conducted in UH settings or a single time point research biospecimen collection studies (so long as there are no research procedures which could be billed to a patient’s insurance.)

E-mail the following documents to OCRAReview@njms.rutgers.edu

The NJMS-OCRA representative will provide you with an e-mail, copying the UH Office of Clinical Research Services, which acknowledges receipt of your documents. You may upload a copy of the e-mail to your eIRB application to provide proof of notification to UH.

Important: You are asked to forward a copy of your eIRB approval to the UH Office of Clinical Research Services at UH-CRS@uhnj.org upon receipt, so that your study can be forwarded for final UH approval.

Quality Assurance/Quality Improvement (meeting the definition of Non-Human Subjects Research)

Please forward a pdf of the completed eIRB application and any stand-alone narrative description of the proposed project to at UH-CRS@uhnj.org

Note: A fully executed UH research plan will be required for a QA/QI project in the following circumstances: 1) if a student who does not already have access to Epic, requires access in order to assist with data collection, or 2) if a report from UH IST will be requested. In this case, the study team must follow the process identified above for Retrospective Chart Review studies.