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New Jersey Alliance for Clinical and Translational Science

Scope

The Rutgers Health Clinical Trials Office (CTO) oversees a broad range of clinical research studies and is the University’s responsible party for a variety of administrative activities. The CTO uses OnCore, a Clinical Trial Management System, to manage studies under its purview.

Studies that fall under the purview of the CTO and, therefore require entry into OnCore include those which:

  • Have a Rutgers Health faculty member (outside of CINJ) as Principal investigator
  • Are conducted at a Rutgers Health location or partner hospital facility
  • Meet either of the two following definitions:
    1. An NIH-defined clinical trial
    2. Non-interventional study which entails/requires billable clinical procedures (i.e. procedures associated with a CPT code, such as a CT scan, MRI, clinical laboratory testing)

 

The specific services that full under the CTO’s purview include:

Mandatory Services and Responsibilities

  • Accrual tracking for any study meeting the NIH definition of a clinical trial
  • Negotiation of CDAs and CTAs for any study sponsored/funded by “industry” or for-profit organizations
  • Negotiation or review of budget development for any study sponsored/funded by “industry” or for-profit organizations
  • Coverage Analysis for any study meeting the definition of a CMS qualifying clinical trial in accordance with NCD 31.1
  • Referral of any clinical research study authored by a Rutgers Health investigator that entails informed consent to the Scientific Review Board
  • Manages the OnCore CTMS, as well as several other electronic clinical research tools and solutions

As Needed Services and Responsibilities

  • Facilitates partner hospital affiliate’s services and processes (scope varies depending on which the partner hospital is involved)
  • Oversees processes for ensuring billing compliance for any study entailing billable clinical procedures conducted at/by a partner hospital affiliate

Additional Services

    • Provides orientation for Rutgers-specific processes to new clinical research staff
    • Provides technical assistance to study teams on using social media for recruitment and advises on other recruitment strategies such as Epic’s SlicerDicer and MyChart messaging.
    • Facilitates ResearchMatch on behalf of the Rutgers Institute for Clinical and Translational Science
    • Provides referrals to the NJ ACTS Regulatory Core and other services available for Rutgers Health Clinical Researchers

     

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