Webinar: Expectation vs. Reality: Reporting Obligations to the IRB

Wednesday, June 5 | 1:00-2:15 PM ET

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Overview

Understanding which events to report to the IRB is an ongoing challenge for researchers and IRBs alike. Institutional policies and procedures vary widely, which can further complicate the reporting process. Using real-world scenarios and data, as well as instructive diagrams and charts, speakers will clarify common areas of confusion when it comes to reporting unanticipated problems, adverse events, and safety-related information to the IRB and the institution.

Agenda

  • Role of the IRB
  • Regulatory landscape and obligations for reporting safety and non-safety information to the IRB
  • Distinction between IRB and institutional obligations, and relevant real-word complications

What will I learn?

After attending this webinar, you will be able to:

  • Define the role of the IRB and the institution regarding reporting unanticipated problems and safety information
  • Appreciate the complexities posed by reporting obligations in the regulations and of reporting dynamics at institutions

Who should attend?

IRB members, HRPP/IRB staff, compliance personnel, and researchers will benefit from attending this webinar.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.25 continuing education credits towards CIP recertification. Learn More »

Speakers

Linda-ColemanLinda Coleman, JD serves as the HRPP director at Yale University. She also serves on several university committees. Before joining Yale, Ms. Coleman held several positions at Quorum Review, an independent IRB that serves institutional, independent, and international sites. (In 2016, Ms. Coleman served as Quorum’s vice president of regulatory and legal affairs of Kinetiq, a consulting division of Quorum. Prior to 2016, she served as Quorum’s director of regulatory affairs and general counsel from 2011-2015, and its director of regulatory affairs from 2007-2010. Prior to Quorum and Kinetiq, Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on general health law matters, Medicare and Medicaid reimbursement, litigation, business and transactional, behavioral health, and employment law. Ms. Coleman is actively involved with several professional organizations. Some of her areas of involvement include IRB harmonization, decentralized clinical trials, Common Rule and single IRB implementation strategies, research data protection, clinical trial process improvement, research quality and compliance, and the use of technology in research. She is also a frequent presenter on a variety of topics such as operations management, research integrity, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics.



Mitchell-ParrishMitchell Parrish, JD, RAC, CIP is vice president of regulatory at Advarra. His career has focused on solving pressing issues impacting innovative medical research, digital health, and software designed to support clinical trials. Mitchell’s experience includes serving as general counsel for Quorum Review, a consultant to the National Cancer Institute, regulatory counsel to a large central IRB, and an associate attorney at the global law firm K&L Gates. He frequently speaks and writes on FDA, clinical trial, and IRB topics and is faculty for the Regulatory Affairs Professionals Society (RAPS), a steering committee member for Harvard’s Multi-Regional Clinical Trials Center (MRCT), and on the board of directors for Life Science Washington.

Additional Resources

A collection of relevant readings accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Individual rates
Member $145
Nonmember $200
Group rates
Member $325
Nonmember $400

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