2. Current Challenges & Opportunities in Clinical Research Compliance

3. Current Challenges and Opportunities in Clinical Research Compliance Gayle Kusch, Sr. Director, Compliance, Research Integrity Office, Wayne State University & Director, Michigan Neonatal Biobank Monica Malian, System Executive Director, Clinical and Translational Research, Detroit Medical Center Ginette Borovicka, Manager, Research Integrity, Research Integrity Office, Wayne State University

4. Current Challenges and Opportunities in Clinical Research Compliance This session will be a panel exploring various perspectives of how monitoring activities are conducted throughout a Human Research Protection Program (HRPP). Discussion topics include: how various components of a HRPP work together to monitor research compliance of clinical studies, challenges & opportunities for collaborative monitoring. Monitoring triggers; for-cause audits versus established/scheduled monitoring. This discussion will also explore internal monitoring and review committees, data safety monitoring boards and plans, etc. Audience participation will be encouraged for sharing ideas and experiences.

5. Human Research Protection Program (HRPP) General Components Upper Administration Legal Counsel Sponsored Programs Technology Commercialization Investigators Research Staff IRB Members IRB Staff Compliance/Integrity Office Department Deans/Chairs Contractual Entities Other Review Committees Institutional Biosafety Radiation Safety Scientific Review Financial Conflict Interest DID I MISS ANY (I am sure I did)

6. Challenges & Opportunities for Collaborative Monitoring Before the Clinical Research Begins Legal Counsel/Sponsored Programs/Technology Commercialization Research Related Injuries Does the Clinical Trial Agreement Match the Informed Consent How does your Institution handle this? Material Transfer Agreements Other Review Committees Institutional Biosafety, Radiation Safety, Scientific Review, Financial Conflict of Interest Do other Contracted Entities have other reviews that need to happen (Billing Compliance) What other reviews/process does your Institution have?

7. Challenges & Opportunities for Collaborative Monitoring After the Clinical Research Begins Monitoring – Scheduled…Not For Cause WSU Experience Karmanos Cancer Institute – Audits 12 Investigator Initiated studies per year If problems found report sent to IRB VAMC – Research Compliance Officer conducts a consent audit on all open protocols once per year Report sent IRB Detroit Medical Center - Tenet, Inc (DMC parent co.) audits all open protocols at one of the DMC hospitals per year. If problem found PI instructed to complete a Unexpected Problem report, and Sr. Director, Compliance notified Opportunities to share experiences

8. Challenges & Opportunities for Collaborative Monitoring After the Clinical Research Begins Monitoring For Cause Triggers – WSU experience Lapses in IRB approval Unexpected Problem Reports Sponsor Audits Problems on Renewal form Problems with an Amendment Local Data Safety & Monitoring Boards Opportunities to share experiences