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Regulatory Support Center (RSC)

Description

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.

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:

  • Develop protocols and informed consent forms utilizing new templates designed specifically for the ICTS
  • 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

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 nine individuals (2 Co-Directors, 6 recruitment coordinators, Medical Director) who will be dedicated to developing and implementing participant recruitment plans across all ICTS studies. The REC will incorporate the Volunteer for Health TM database, an existing participant recruitment database that contains more than 22,000 interested and consenting volunteers.

Services Available to ICTS Members

Regulatory Core Services

  • Project Planning Consultation
  • Clinical Trial Contract / Subcontract / Confidentiality Agreement Negotiation
  • IRB submission, follow up & other committees as required
  • Per patient study budget preparation/review
  • Assistance with pre-study site initiation activity

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)

Recruitment Enhancement Core Services

  • Recruitment plan development
  • Subject pre-screening and referrals
  • Access to VFH database (~22,000 volunteers)
  • Advertising development and placement