Federal mandates for single IRB (sIRB) review of multisite research have ushered in a new era of sIRB oversight. Multisite research funded by NIH, HHS, and other agencies must now be overseen by just one IRB, phasing out the previous duplicative and inconsistent practice of multiple IRBs reviewing the same study.
This complicates things for researchers and institutions who have historically relied on their local IRBs. Reliance agreements must be established, policies must be modified or developed anew, and research staff must be trained on the updated IRB process.
In this webinar, Stephanie Pyle, Director of Content and Communications at Advarra, guides institutions through the basics of working with an external sIRB for the first time, including insights into the sIRB relationship and what institutions should expect of their external IRB partners.
This webinar was developed in collaboration with Advarra’s Operations, Regulatory, and Institutional Services Teams. While the presentation will use examples from Advarra to illustrate certain points, this webinar is intended as a general, educational introduction to working with an external sIRB.
Director, Content and Communications
Institutional representatives involved in the IRB review process, including: research directors and managers, IRB directors and managers, principal investigators and their research staff, and sponsor and CRO representatives involved in institutional site startup activities. This presentation will be particularly helpful for those individuals who have not worked with sIRBs.
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 and 1 hour of continuing education credit for the Certified IRB Professional (CIP) certification. 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.
After completing this webinar in its entirety, you will receive a certificate of attendance. This certificate will include your full name and it will be emailed to you within 24 hours 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 take the survey at the end. Visit our Webinar Help page for more information on certificates of attendance.