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Rutgers University Office of Research logo Rutgers University Office of Research logo Rutgers University Office of Research logo
Rutgers University Office of Research logo Rutgers University Office of Research logo Rutgers University Office of Research logo
Rutgers University Office of Research logo

The RBHS Clinical Trials Office

The Rutgers Biomedical and Health Sciences’ (RBHS) Clinical Trials Office (CTO) was formed in 2020 under the Rutgers Institute for Translational Medicine and Science, with support from the RBHS Chancellor’s Office and NJACTS. 

Overview 

The mission of the CTO is to improve the quality and efficiency of the clinical trials conducted at RBHS by centralizing administrative functions, such as contract and budget negotiation, Medicare Coverage Analysis, and partner hospital agreements, and by harmonizing processes and procedures across RBHS.  The CTO works with the clinical research units across the campuses to offer seamless support to our faculty in implementing their clinical research.

The RBHS CTO is focused on providing support for RBHS clinical researchers outside of CINJ in their conduct of clinical trials and other prospective studies with billable clinical procedures, irrespective of funding source. Learn more about the resources that RBHS CTO provides or to reach out to the CTO staff directly via email.

The Clinical Trials Office Regulatory Knowledge & Support

The Regulatory Core offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. The goal is to provide the NJ ACTS community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research. Learn more about The Clinical Trials Office's regulatory knowledge and support guidance.

Regulatory Support Services

The NJACTS Regulatory Support office is a centralized resource for all researchers. We bring unique expertise to benefit the entire research team, from research coordinators to Principal Investigators. We can provide knowledgeable guidance and advice with local and federal regulations, and facilitate early engagement and education for stakeholders for the timely and complete submission of necessary applications.

The CTO Regulatory Support Office can help to:

  • Answer general or specific questions about regulatory rules and approval process
  • See if your project meets the definition of human subjects research
  • Problem-solve on proposed projects, including protocols, consent forms, eIRB, etc.
  • Help determine the type of IRB submission required (full board vs. expedited vs. exempt)
  • Assist with additional regulatory requirements (i.e. IACUC, Institutional Biosafety, data sharing agreements, material transfer agreements, IND submissions, clinicaltrials.gov, etc.)
  • Determination of compliance documents for NJ ACTS Pilot Award Recipients
  • Advise on the clinicaltrials.gov (CTG) process

Consultations are available, and the information you provide is confidential. To arrange a Regulatory Consultation, complete this form. The CTO Regulatory Team Members include Anthony Gonzalez, QA/QC Manager, NJACTS and Farah Anwar, Regulatory Affairs Manager, RBHS CTO.