Bootcamp for New Investigators in Clinical Research: Session 4 - Mastering Event Reporting

CTSI-CN KL-2 Special Interest Group Workshop Series
KL-2 SIG: Mastering Event Reporting
When
-
Where

Online

Contacts

Contact Pesha Rubinstein to attend via Zoom at gwsmhsresearch@gwu.edu

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