Ask Advarra Live: The Real-World Impact of COVID-19 on Research

The unprecedented COVID-19 pandemic has quickly changed how we live and work. This extraordinary situation has resulted in a significant impact on IRB-approved protocols and research yet to go through the IRB process. In addition, IRB review of COVID-19 research itself has raised unique and challenging issues with the application of various regulatory criteria in the Revised Common Rule and the FDA Regulations.

Find out about specific issues the research community has encountered during the current pandemic from experts in human subject protection and institutional research administration—and gain practical guidance you can use immediately.

The webinar includes dedicated time to discuss real-world questions submitted by the research community. Presenters will also review recently released regulatory guidance, identify IRB issues and concerns in reviewing COVID-19 research, and describe how to manage pandemic-related changes to ongoing research, including enrollment holds and suspensions.

Learning Objectives

Following this free webinar, attendees will be able to:

Identify unique IRB considerations during the COVID-19 pandemic.
Apply current best practices to new and ongoing research during the COVID-19 pandemic.
Describe current regulatory guidance relating to the impact of COVID-19 on IRB review of research.

Presented By

Michele Russell-Einhorn

Chief Compliance Officer and Institutional Official
Advarra

Megan Kasimatis Singleton

JD, MBE, CIP

Assistant Dean, Human Research Protection; Director, HRPP
Johns Hopkins University School of Medicine

Judith Carrithers

JD, MPA

Director of Regulatory Affairs
Advarra

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Who Should Watch?

Research professionals involved in developing, conducting, and overseeing research during COVID-19 pandemic, including representatives from sponsors, CROs, sites, and IRBs.

CEU Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

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.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education 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.