Office of Clinical Research Administration

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

• Final version of protocol to be submitted to the IRB. (Note: the required Rutgers IRB HRP-503c template for Secondary Research with Data or Biospecimens can be found https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit)
• Completed UH chart review registration form, signed by the Principal Investigator
• Completed UH research plan, signed by the Principal Investigator (provided the study has no external funding. Should the study have external funding, eliminate completion of the UH research plan and provide the RAPSS Funding Proposal number instead.)

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.

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/

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

• Protocol using the Rutgers IRB using the appropriate template (found at https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-toolkit)
• Completed UH Scope of Services form
• Completed UH research plan, signed by the Principal Investigator (provided the study has no external funding. Should the study have external funding, eliminate completion of the UH research plan and provide the RAPSS Funding Proposal number instead.)

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.

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.