A patient in a clinical trial breaks his leg in a skiing accident - is it an SAE?
No - it's not even an AE
Yes - no question
Yes if he stayed in hospital overnight or had serious complications
Only if he withdrew from the study
Learning Management Centre
My GCP Zone Login
Retrieve Online Order
PharmaSchool Online Courses:
Click here for the full range of Online GCP, Clinical Research and Development Courses from PharmaSchool.
Users in the following countries:
News & Corporate Information
Terms & Conditions