Participant and Clinical Interactions

The iRISE Participant and Clinical Interactions module serves as a catalyst for transformative and collaborative interdisciplinary clinical and translational research. We provide clinical research support to individual researchers or multidisciplinary research teams. In addition we provide resources and infrastructure for the ethical conduct of human subject-based translational and clinical research in adults and children.

Overview

Specifically we offer research environments that promote optimal study design, quality, safety, ethics and regulatory compliance in clinical research. We assist iRISE investigators with the development and refinement of workflows and assist with all aspects of clinical and translational research from study design through implementation, enrollment and data collection to closeout and publication of results.

The PCI falls under the remit of the UTHSC Office of Clinical Research (OCR). The OCR’s mission is to provide comprehensive centralized transparent clinical research services to all UTHSC investigators, to improve quality, efficiency, and compliance of trials, and to enhance the ability of UTHSC to fulfill its research mission.

Of note, although some of the functions are similar or overlap, the mission and activities of the OCR extend beyond the PCI to encompass all clinical trials/studies conducted at UTHSC, while the specific functions of the PCI are limited to iRISE-associated projects.

In building the OCR, independent of CTSA funding, new solutions to the above challenges have been realized and are being incorporated into the following related PCI functions:

  • Budgets/Grants/Contracts
  • Clinical Trials Management System
  • Patient/Office Facilities
  • Nursing/Study Coordination
  • Invoicing and payments
  • Identification of Research Funding Opportunities
  • Community-Based Research
  • Quality Assurance
  • Adult/Pediatric Integration

Scientific Advisory Committee Review

This advisory board is comprised of experts equipped to review and evaluate all aspects of an application.

The study PI prepares a summary of the proposed study for the SAB members 2 weeks prior to a regularly scheduled monthly meeting. The PI will attend the monthly SAC meeting and briefly present the study followed by questions from the committee. SAC Meetings are timed to coincide with IRB meetings allowing joint approvals to progress rapidly.

The committee evaluates projects for support based on the following criteria as indicated by the particular study:

  1. Scientific merit,
  2. Feasibility,
  3. Relevance to the iRISE Mission,
  4. Synergy with other ongoing clinical and translational research on campus,
  5. Likelihood of generating significant external funding,
  6. Budget and justification, including availability of other internal funding sources, and
  7. Use and availability of iRISE and PCI resources and personnel.

Approved projects are provided with OCR services on a reduced cost basis using personnel within the OCR supported by iRISE through the PCI module.

If a project is not approved, the committee will provide a full critique to both the PI, as well as the IRB. PIs of approved projects are obligated to provide the committee with a progress report every 6 months, and the committee may empowered to modify, revoke, or extend approval based on these reports or other observed findings.

Dr. Ari VanderWalde
Associate Vice Chancellor of Clinical Research The UTHSC Associate Vice Chancellor of Clinical Research, Dr. Ari VanderWalde oversees the PCI module. Dr. VanderWalde is an internist specializing in Oncology clinical trials research and holds a clinical appointment at the West Cancer Center in addition to his role at UTHSC. He spent 3 years as a Clinical Research Senior Medical Scientist and Medical Director at Amgen prior to joining the WCC and UTHSC. He brings a wealth of experience with clinical trials from a pharmaceutical perspective and holds primary responsibility for re-organizing the clinical trials apparatus at UTHSC, in conjunction with our clinical partners, to better support research in a CTSA 2.0 model.
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