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.
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 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 (pdf), including Research Coordinator services.
This program provides the following:
- Research participant advocacy functions for clinical studies conducted throughout the ICTS, by offering information, assistance and facilitating research participant satisfaction
- Monitors and supports protocol adherence, adverse event reporting, and informed consent procedures
- Provides on-site regulatory resources for participants, investigators, nurses, and staff at each ICTS Research Unit
- 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
- Informed Consent development for PI-initiated protocols
- Assistance in completing regulatory forms such as FDA IND applications
Fill out the Service Request Form and submit to the consultation team at firstname.lastname@example.org.
Requests for CCS Budget or IRB preparation services (related to industry or non-industry studies) email email@example.com.
Service available to:
All entities, including for-profit organizations, with priority given to members of the ICTS and centers listed in the “Affiliations” below.
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 (pdf) for more information.
Yi Zhang, JD, RN, RSC Director
Michelle Jenkerson, RN, RSC Associate Director
Jeanne Velders, JD, RN, Regulatory Core