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Need A Single E2b Template For Bfarm That Handles Latest Ema Requirements For Spontaneous And Clinical Trial Cases (Doc ID 1417265.1)

Last updated on APRIL 22, 2021

Applies to:

Oracle Argus Interchange - Version 5.1 and later
Information in this document applies to any platform.


BFARM also updated their SUSAR rules to the same as the EMA requirements. As BFARM have only one E2B destination, we cannot use a dedicated template as we have for EVCTMPROD as this is hard coded.

Do you have a solution where one template, going to one destination can be used for Spontaneous cases (no changes applied) and for cases with Observe Study Type of Clinical Trial the values are updated with the new requirements? We were not aware BFARM were also changing and this has caused several companies a problem.


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