Didn’t Expect that to Happen: Events that must be Reported Promptly to the IRB
After a new study is approved, researchers must promptly report certain events to the IRB for evaluation. This is in addition to other required notifications to other entities, like regulatory agencies and the study sponsor, and managing these various reporting obligations can sometimes be complicated.
In this webinar, Lauri Carlile, Advarra Sr. Vice President, Operations, and Tom Closson, Advarra Executive Director, IRB Services, Safety & Ongoing Review, explain what does and does not need to be reported to the IRB. They provide definitions of reportable events, such as unanticipated problems (UAPs) and unanticipated adverse device events (UADEs), and discuss example scenarios to help researchers better understand how to evaluate potentially reportable events.
After attending this free webinar, attendees will be able to:
- Explain why reporting to the IRB is necessary
- Describe the impact of under-reporting and over-reporting
- Identify the types of events that must be reported promptly to the IRB
Sr Vice President, Operations
BS, RPh, CIP
Executive Director, IRB Services, Safety & Ongoing Review
Who should watch?
This content applies to investigators and site staff, sponsor representatives, CRO representatives, and other research professionals involved in reporting to the IRB
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.
Provider approved by the California Board of Registered Nursing, Provider Number 17600, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.
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.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour