Regulatory Support Center (RSC)

The Regulatory Support Center is an expansion of the existing Center for Clinical Studies and is designed to provide support for ICTS investigators in overcoming organizational barriers, navigating through the regulatory requirements for human research, and recruiting adequate numbers of appropriate research participants for studies. To that end, the RSC has established three Cores:

1. Regulatory Core

The Regulatory Core of the RSC provides regulatory services to ICTS investigators, spanning the regulatory process from initial submission through study close out. This group has extensive regulatory experience, including preparation of IRB and related regulatory submissions, maintenance of approvals, adverse event reporting, protocol amendments and required annual renewals. This process is interactive between the PI, sponsor, reviewing committee, coordinator and the CCS regulatory specialist, to optimally facilitate approvals.

The RSC Regulatory Core is currently comprised of four individuals (Director, 2 Regulatory Consultants, Billing Matrix coordinator) and will assist ICTS investigators and trainees to:

  • Prepare, submit and obtain the necessary approval for all start-up documents related to a clinical study
  • Identify institutional review committees and meet submission requirements
  • Complete sponsor and FDA required regulatory submissions
  • Identify and coordinate consultation with other subject area experts such as Biostatistics, Clinical Research Ethics, Biomedical Informatics, Participant Recruitment, Research Pharmacy, Human Imaging Unit, Center for Community-Based Research and others as required

The RSC provides services at multiple levels, including Research Coordinator services.

2. Participant Advocacy and Ombudsman Core

The Participant Advocacy and Ombudsman Core provides the key components of the Research Subject Advocate (RSA) program, previously supported by the General Clinical Research Center (GCRC). Activities include:

  • Research participant advocacy and ombudsman functions for clinical studies conducted throughout the ICTS, by offering information, assistance and facilitating research participant satisfaction
  • Monitor and support protocol adherence, adverse event reporting, and informed consent procedures
  • Provide on-site regulatory knowledge resource for participants, investigators, nurses and staff at each ICTS Research Unit

3. Recruitment Enhancement Core (REC)

The REC helps ICTS investigators establish and meet study recruitment targets (including adequate participation by women and underrepresented minorities) while ensuring regulatory compliance and the highest ethical standards in participant recruitment.

The REC is comprised of dedicated recruitment specialists for developing and implementing participant recruitment plans across all studies. They deliver systematic, data-driven, and strategic support to optimally recruit and retain eligible research participants.

Services & Resources

Regulatory Core Services

  • Project Planning Consultation
  • Clinical Trial Contract / Subcontract / Confidentiality Agreement Negotiation
  • IRB submission, follow up & other committees as required
  • Negotiate budgets and payment terms with sponsors
  • Per patient study budget preparation/development
  • Assistance with pre-study site initiation activity
  • Provide study coordinators for PIs needing assistance with a given clinical study
  • Protocol development assistance for PI-initiated protocols
  • Informated Consent development for PI-initiated protocols
  • Assistance in completing regulatory forms such as FDA IND applications

Participant Advocacy and Ombudsman Core Services

  • Review of protocols to address ethical issues
  • Development, maintenance & training on ICTS Site SOP’s
  • On-going training & orientation programs for CARS coordinators and nursing staff
  • Addressing concerns raised by ICTS research participants
  • Assistance in addressing sponsor & regulatory audit issues for ICTS studies (e.g. FDA audit responses)
  • Development & implementation of a research participant satisfaction survey
  • Development & implementation of a CARS / RSC user satisfaction survey
  • Monitoring of studies to promote adherence to human subject protection regulations and adoption of operational best practices

Recruitment Enhancement Core Services

  • Recruitment plan development
  • Electronic medical records searches and research data repository queries (consistent with IRB and HIPAA rules)
  • Detailed patient chart reviews
  • Creation and placement of free or paid HRPO-approved media ads
  • Community-based visits to strategically appropriate sites to generate referrals
  • Pre-screening services for potentially eligible participants

Facilities & Other Resources

For a description of RSC and other ICTS resources, see the Tools and Resources page.

Good Clinical Practice (GCP)

Training investigators and research teams to competently conduct clinical research is crucial to successful translation of novel drugs, devices, and interventions.  The GCP training platform, funded through a 2014 Administrative Supplement, includes test out features allowing individuals to demonstrate competency at the level of individual modules.  See the OVCR website or the GCP Quick Start Guide for more information.