As per new FDA Requirement, a new causality field is needed in Argus Safety
(Doc ID 1360698.1)
Last updated on MAY 05, 2021
Applies to:Oracle Argus Safety - Version 22.214.171.124 and later
Information in this document applies to any platform.
The FDA has issued new regulations that support a more specific causality assessment in clinical trials.
The respective causality assessments are FDA specific and need to be kept apart from the causality assessment for other regulators, such as the EMA or European CAs.
The rule becomes effective September 1, 2011.
Argus needs to provide a 3rd causality field at the level of the as reported / determined causality.
Can you please explain how we can do this in Argus Safety.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document