Clinical Research Resource Guide

The Rutgers Health Scientific Review Board supports investigator-initiated studies by reviewing non-oncology protocols to assess proper statistical design, enrollment goals, feasibility (including adequate research staffing, competing trials, funding, resources, and departmental support) to help accelerate IRB approval and to help ensure study success.

The Scientific Review Board (SRB) ensures that the scientific question being asked within a protocol is relevant and that the design of the protocol is appropriate to answer that question.

For information on the Rutgers Health Scientific Review Board (SRB) please visit: https://njacts.rbhs.rutgers.edu/investigator-resources/regulatory/scientific-review-board/

If your study meets the following criteria for SRB review, please click on this link to submit to the SRB for review: https://redcap.rutgers.edu/surveys/?s=C8E4XE4A9KNN4AAX

Criteria for SRB Review: 

All of the following criteria must be met for SRB review:

• Principal Investigator is a Rutgers Health faculty member outside of CINJ
• Rutgers Health investigator-initiated protocol (i.e., not sponsored by industry or an NIH consortium)
• Study entails obtaining consent of study participants

An Institutional Review Board (IRB) ensures the protection of the rights and welfare of human research subjects based on the rules and regulations of the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) by approving, requiring modifications in, or disapproving Human Subject Research projects.

Link to IRB and HRPP services: https://research.rutgers.edu/faculty-staff/compliance/human-research-protection

DRAFT Services (formerly known as Pre-Review Service) stands for “Document Revision And Feedback Team”. The mission of the DRAFT Service is to improve submission outcomes by recommending and educating study teams on HRPP/IRB considerations and best practices. It is highly recommended that the DRAFT Service is used by investigators prior to submitting new studies or substantial modifications to existing studies in eIRB.

Link to IRB Draft Services: https://research.rutgers.edu/faculty-staff/compliance/human-research-protection/draft-services 

The Rutgers Biosafety Program in the Department of Environmental Health and Safety (REHS) is responsible for overseeing research performed with: recombinant and synthetic genetic material, pathogenic microorganisms (affecting humans, plants and animals), select agents and toxins, human material and human cell lines, transgenic plants and transgenic animals 

Link: https://ipo.rutgers.edu/rehs/biosafety-program 

IATA training is required before shipping Dangerous Goods and other regulated materials. If any transport will involve the need to transfer materials through city streets or in a personal vehicle, REHS must be contacted beforehand, as there may be additional trainings and requirements. Rutgers personnel are not permitted to transport certain materials in vehicles (e.g., Category A Infectious Substances). Please contact biosafety@rutgers.edu for more details. 

Link: https://ipo.rutgers.edu/rehs/shipping-biological-material 

As part of the overall mission to improve the efficiency and quality of the clinical trials conducted at Rutgers Health, the Rutgers Health Chancellor’s Office and NJACTS have invested in eReg, an electronic regulatory filing system. 

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

Rutgers offers secure, web-based platforms for survey design and data collection. REDCap is tailored for clinical and translational research, supporting regulatory compliance, longitudinal data, and database management. Qualtrics provides advanced survey design, branching logic, and analytics, making it ideal for participant feedback, program evaluation, and research projects. Together, these tools give investigators flexible options for capturing, managing, and analyzing study data

REDcap: https://redcap.rutgers.edu/

Qualtrics: rutgers.qualtrics.com

The CRDW provides researchers with secure access to comprehensive, de-identified patient data from Rutgers-affiliated health systems. It supports study feasibility, cohort discovery, and data extraction for clinical and translational research. Researchers can request customized datasets to accelerate study design, recruitment, and evidence generation, while ensuring compliance with HIPAA and institutional policies.

Link: https://it.rutgers.edu/clinical-and-research-data-warehouse/

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. 

A major objective of NJ ACTS is to successfully translate biomedical discoveries to clinical applications by promoting creative and innovative science. The NJ ACTS Pilot Program offers pilot grants to foster collaborative research among faculty in three institutions: Princeton University, New Jersey Institute of Technology (NJIT)and Rutgers University. These pilot projects will then provide a path to sustainable, extramurally funded independent research across the alliance. The NJ ACTS Pilot Program is funded through the generous support of the NIH CTSA Award, the New Jersey Health Foundation, and each of the academic partners.

Link: https://njacts.rbhs.rutgers.edu/investigator-resources/funding-opportunities/pilot-grants-2/

Research Protocol Templates serve as a starting point when crafting a Research Protocol document. Templates contain all required elements for Rutgers IRB approval and detailed instructions.

For guidance on how to write a good protocol the HRPP office can provide that guidance and information. Visit the links below for more information.

Research protocol templates: https://research.rutgers.edu/faculty-staff/compliance/human-research-protection/toolkit#tab=panel-7&chapter

PIVOT is a comprehensive database that helps Rutgers researchers find funding opportunities and potential collaborators. It offers personalized searches, funding alerts, and tools to track opportunities across federal, foundation, and international sponsors, streamlining the grant discovery process.

Link: https://www.libraries.rutgers.edu/databases/pivot