Lessons Learned for Meeting Safety Reporting Requirements in Retrospective Chart Review Studies

Time

Wed, Jun 17 9:00AM
W 33

Title

Lessons Learned for Meeting Safety Reporting Requirements in Retrospective Chart Review Studies

Abstract Summary

ORAL PRESENTATION SCHEDULED: Wednesday, June 17 in Session #2B at 1:20 - 1:25 pm in the Exhibit Hall Poster Area (Hall A entrance)

Case study safety reporting processes and lessons learned will be synthesized and described in support of successful adverse and serious adverse event (AE/SAE) reporting that meets regulatory and Sponsor requirements.

Poster Presenter

Catherine Sigler
DVM, PhD, MPH,
Executive Director, Safety, Epidemiology, Registries, & Risk Management (SERRM),
UBC, An Express Scripts Company
United States