Clinical Trial Series

Webinar 3: Implications of a Prospective Clinical Research Monitoring Program on IRB Operations

August 2, 2011

As part of a quality improvement (QI) initiative conducted by The Office of Research Compliance and Education and the IRB Administration Office, an analysis of common observations encountered during research compliance monitoring visits was reviewed to determine the impact on IRB administrative operations. The QI initiative focused on administrative improvement regarding the informed consent process, protocol consistency and managing potential noncompliance. This resulted in improvements in research administration processes which included the implementation of specialized education with the IRB committees, a protocol and contract reconciliation program, and revisions of management procedures for review of minor non‐compliance. The data has shown that there are many opportunities for collaboration between the IRB and ORC to continue to encourage and enhance the responsible conduct of research.

After this Webinar, attendees will be able to: 1. Identify the common observations identified through research monitoring which can impact research administration operations across the Human Research Protection Program (HRPP); 2. Implement targeted quality improvement initiatives at your institution.

Instructors:Carol Fedor, ND, CCRC, Clinical Research Mgr, Ctr for Clinical Research and Technology, Univ Hospitals Case Medical Center
Joseph Gibbons, Asst Prof of Medicine, Comprehensive Cancer Ctr, Univ Hospitals of Cleveland and Case Western Reserve Univ

Series consists of five webinars on successive Tuesdays, beginning July 19. 

All attendees will receive 1.5 RCR contact hours.

Please RSVP to Research Integrity:  email