Clinical Operations & Trial Management
Research Infrastructure & Technology

General questions about study feasibility/Sponsor feasibility questionnaires:  The Rutgers Health Clinical Trials Office offers assistance with determining whether a study is feasible to conduct.  General questions about conducting a clinical trial as well as requests for assistance in completing a sponsor’s feasibility questionnaire may be directed to ClinicalTrials@rbhs.rutgers.edu 

Deep6 AI is an artificial intelligence software program which is interfaced with the RWJBH and UH-Newark electronic medical record systems (EMR).  It mines the EMR for structured and unstructured data and can be used to generate a report of the number of potentially eligible patients for a trial.  This can be an extremely useful tool for grant applications as well as to help investigators decide whether they will be able to recruit for a clinical trial under consideration.   

Questions about using Deep6 may be directed to clinicaltrials@rbhs.rutgers.edu , or you may request a Deep6 Feasibility query by completing this form and selecting “Deep6 Query Build Request.” 

Any study conducted by a Rutgers Health Investigator which is conducted locally at Rutgers Health or one of its partner hospitals and either meets the NIH definition of a clinical trial or entails billable clinical procedures must be entered into OnCore.

Link: https://njacts.rbhs.rutgers.edu/clinical-trials-office/solutions/oncore/

SlicerDicer, a self-service tool within Epic, can be used to generate a report of a valuable resource for researchers to determine study feasibility.  For example, researchers can create a query and run a report to determine the number of patients within the EMR system with a particular diagnosis of interest, and further select for criteria such as age, co-morbid conditions, concomitant medications, etc. Note that researchers must have access to Epic to use Epic Tools.

RAPSS is used university-wide for pre-award grant and contract functions, such as electronic endorsement of proposals and submission through grants.gov to federal agencies. 

RAPSS is mandatory for all new submissions of research proposals, corporate contracts, and associated items. Link to RAPSS: https://research.rutgers.edu/tools-resources/rapss

Contracts for clinical research (including clinical trial agreements, confidential disclosure agreements, data use agreements, etc.) are negotiated and executed by the University on behalf of the investigator.   

Most agreements for clinical research are handled by Research Contract Services within the Rutgers Office For Research.  Requests for management of a contract are made by submitting a Document Review record within RAPSS. 

The Rutgers Health Clinical Trials Office maintains responsibility for managing non-oncology clinical trial agreements and amendments for industry sponsors.  They are also responsible for executing ancillary agreements (such as site agreements and research plans with partner hospitals) for non-oncology clinical trials.   

For studies which are already in the OnCore Clinical Trial Management System, a Document Review record for clinical trial agreements and CTA amendments does NOT need to be completed in RAPSS.  (Note, though, the study will have a Funding Proposal and Award set up through RAPSS.)  

Government/Non-Profit Sponsors:  Tools for budget preparation may be found under Pre-Award services for the Rutgers Office for Research 

The Rutgers Health Clinical Trials Office provides budget development and negotiation services for industry-sponsored clinical trials.  These services are provided as part of the workflow for the study through OnCore. 

Link: https://njacts.rbhs.rutgers.edu/clinical-trials-office/services/budget-development/

Coverage Analysis is a two-step process whereby a determination is made as to whether a study qualifies for Medicare (or other third-party payor) coverage and which (if any) of the study related items and services may be submitted to third party payors and which must be paid for by the study.    The purpose of performing this analysis is to assure proper billing of all research procedures and compliance with the Medicare Clinical Trials Policy (NCD 310.1.)  The Rutgers Health Clinical Trials Office provides this service as part of its workflow through OnCore. 

University Hospital-Newark 
All studies conducted using UH-Newark resources (including the Epic system) require hospital review and approval.  Click here for the form to complete.  Click here for additional information on these processes.   
UH-Newark Epic Access:  Click here for information on how to access the UH-Newark Epic electronic medical record system. 

RWJBarnabas Health 
All studies conducted using RWJBH resources (including the RWJBH Epic System) require health system review and approval. Requests to conduct research at RWJ University Hospital in New Brunswick are handled by the RWJUH Institutional Research Committee (IRC.)  This form may be accessed only on the hospital’s intranet via “The Bridge” under quick links, “RUG/IRC Allocation of resources New Brunswick.”
Studies involving data-only, studies involving RWJBH hospitals other than RWJUH, or studies involving multiple RWJBH hospitals (including RWJUH) are reviewed by the RWJBH Central IRC.  To request review by this committee, email the RWJBH Central IRC rwjbh-irc@rwjbh.org to request the package of forms to complete.  

Five clinical research units are available through Rutgers Health to provide Rutgers investigators, on a fee-for-service basis, with access to trained clinical research staff as well as clinical space to conduct study visits and procedures.  Click here for more information. 

Link: https://clinicaltrials.rbhs.rutgers.edu/clinical-trials-office/resources/clinical-research-units/

Deep6 AI Cohort Builder:  Deep6 AI is an artificial intelligence software program which is interfaced with the RWJBH and UH-Newark electronic medical record systems (EMR).  It mines the EMR for structured and unstructured data.  With IRB and hospital approval, Deep6 may be used to generate a list of potentially eligible patients for a trial.    This service may be requested by completing this form and selecting “Deep6 Query Build Request” AND “Deep6 Whitelisting /Study PHI access.”  Note that, for industry-sponsored studies, a standard fee of $2500 is typically incorporated into the sponsor budget as a line item. 

Questions about using Deep6 may be directed to clinicaltrials@rbhs.rutgers.edu 

Epic’s SlicerDicer is a self-service tool that can be used to identify potentially eligible patients within the RWJBH Epic System (provided IRB approval has been obtained.)  Once a list of potentially eligible patients has been identified, and IRB-approved message may be sent to these patients via MyChart, the Epic patient portal.  These tools are available only to RWJBH Epic users and must be requested within Epic via ServiceNow by navigating to the “Research Data and Recruitment Request” form within the IT Service Catalog.   

Placement of recruitment ads on various social media channels (such as FaceBook and Instagram) may be a very effective tool for some studies.  Social media consults are available through the Clinical Trials Office.  Inquire by sending an email to clinicaltrials@rbhs.rutgers.edu 

ResearchMatch is an NIH-sponsored clinical research registry of over 160,000 volunteers nation-wide who are interested in participating in research. Rutgers researchers may use ResearchMatch for study feasibility purposes, to obtain aggregate data, and, with IRB approval, as a means to recruit study participants.  Click here for more information.   

Five clinical research units are available through Rutgers Health to provide Rutgers investigators, on a fee-for-service basis, with access to trained clinical research staff as well as clinical space to conduct study visits and procedures.  Click here for more information.