On-Demand Webinar

Preparing Your Action Plan for the FDA sIRB Mandate

FDA’s anticipated sIRB mandate at the end of this year will mean broad changes for the entire research community.

Join our webinar for practical guidance from IRB thought leaders on what to include in your sIRB reliance preparations. Presenters will share real-world learnings and experiences gained from navigating current sIRB mandates in preparing IRB offices for possible FDA sIRB requirements. This includes ideas for restructuring HRPP resources, and actionable insights for coordinating with external partners and improving critical timelines.

Learning Objectives:

  • Outline key tasks to include when developing an sIRB reliance plan for your institution/site
  • Assess current HRPP infrastructure for gaps and other potential impacts of FDA’s proposed sIRB mandate
  • Discuss the impact of local study activation requirements on sIRB timelines and processes
  • Review potential organizational changes to improve sIRB reliance and overall local research support services

Presented By

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Joshua Fedewa

Director, Consulting – Institutional Research
Advarra

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Adam McClintock

Director, Office of the Institutional Review Board
University of Alabama at Birmingham

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Assistant Clinical Professor, Internal Medicine and Pediatrics
Conventus Site Medical Director for UBMD

Adult Transitional Sickle Cell Program Director Department of Medicine
Jacobs School of Medicine and Biomedical Sciences University of Buffalo

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Who should watch?

Research professionals from research institutions, academic medical centers, hospital systems, and other sites with local IRBs, IRB professionals, research professionals planning and conducting multisite clinical trials regulated by FDA, and others involved in IRB activities for multisite clinical trials.

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now