As per new FDA Requirement, a new causality field is needed in Argus Safety (Doc ID 1360698.1)

Last updated on JULY 13, 2023

Applies to:

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.

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.

Solution

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