CTSC Regulatory Steering Group convened to promote city-wide interaction and collaboration

Faculty, staff members, and invited guests supporting research administration from all four of our partner institutions convened on Wednesday, August 14, 2019 for the CTSC Regulatory Steering Group Meeting. This gathering of over 20 individuals from Case Western Reserve University, the Cleveland Clinic, MetroHealth Medical Center, and University Hospitals Cleveland Medical Center was an opportunity for increased interaction and collaboration, which will continue into the future with standard quarterly meetings.

We discussed two initiatives of the National Center for Advancing Translational Science (NCATS) in which the CTSC is actively involved. In these projects, the Cleveland CTSC is among more than 60 participating CTSA hubs nationwide.

  • Trial Innovation Network (TIN) – Noreen Roman, MBA gave an overview of the TIN and its mission to enhance the execution of multi-center clinical trials. Noreen is the Manager of Clinical Research Unit Operations at MetroHealth and the Point-of-Contact for the CTSC TIN Hub Liaison Team. If you are planning a multi-center study and would like to learn about resources available through the TIN, contact Noreen at (216) 778-3130 or nroman@metrohealth.org.
  • Common Metrics Initiative – Clara Pelfrey, PhD (CTSC, Evaluation Director) described the IRB-related metrics that are tabulated nationally for all Clinical and Translational Science Awards (CTSA) Programs. This particular work is part of the national evaluation teams working on “Turn the Curve” metrics which are intended to decrease regulatory burden on investigators and their staffs while increasing efficiency in regulatory processes.

Philip Cola, PhD (CTSC Regulatory Knowledge and Support Lead) also reviewed the various regulatory-based metrics that are collected locally to measure our CTSC’s progress and to support the aims of the regulatory components of the current active grant. Discussion was held on the similarities and differences between the regulatory-based metrics and the common metrics.

Our guest speaker, Kathy Lawry, MSSA, CIP (SMART IRB Ambassador), provided education regarding the SMART IRB and IREx systems which support reliance agreements and single IRB review. We encourage you to learn more by signing up for the SMART IRB mailing list ( https://smartirb.org/contact/) , accessing webinars ( https://smartirb.org/reliance/), and utilizing the shared tools & resources ( https://smartirb.org/resources/).

For more information on any of these topics, contact Ellen Divoky, CCRP at (216) 368-5976 or ellen.divoky@case.edu . Ellen is the Director of Regulatory, Compliance and Contracting in the Center for Clinical Investigation who will be working closely with all of the above CTSC-related efforts and is the local regulatory liaison for Trial Innovation Network (TIN) studies.