3rd Causality Field Required

(Doc ID 1342404.1)

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety - Version: 4.2.1.8 and later   [Release: 4.2 and later ]
Information in this document applies to any platform.

Goal

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.

Does Argus  provide a 3rd causality field at the level of the as reported / determined causality.


Solution

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