CTSI-CN KL-2 Special Interest Group Workshop Series
Bootcamp for New Investigators in Clinical Research
Session 4: Mastering Event Reporting
A series of four workshops on how to operationalize biologic clinical trials at George Washington University and Children's National Hospital. An emphasis on available programs, templates, and resources.
Adverse Events Reporting
12:00 – 12:15 pm What is a serious adverse event? Bruno Petinaux, MD
12:15 – 12:30 pm Event reporting and the IRB Elissa Malkin, DO, MPH
12:30 – 12:45 pm Event reporting in longitudinal studies Nickie N. Andescavage, MD
12:45 - 12:50 pm BREAK
Clinical Trial Safety Management
12:50 – 1:05 pm Types of safety management plans and processes Robin McGarry, MD
1:05 – 1:20 pm Data Safety Management and the FDA Adelaide Robb, MD
1:20 – 1:35 pm What data can you use (or not use) from the EHR? Kristen Breslin, MD
1:35 - 1:40 pm BREAK
1:40 – 2:00 PM Breakouts: Institutional Solutions to Challenges: Lessons Learned
Emails and discoverability? Who keeps consent forms – paper, “e”, and hybrid? When to involve the IRB? Pharmacovigilance?
GW: Radwa Aly, MSc; Sarah Ford-Trowell, MPA
CNH: Kristen Breslin, MD; Caitlin Joffe, MBA, CCRP; Marissa Horrigan, PharmD