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How To Configure The Certification In B2bconsole To Finish The CDE E2B Submission (Doc ID 2427595.1)

Last updated on MARCH 25, 2019

Applies to:

Oracle SOA Suite - Version and later
Information in this document applies to any platform.


How to configure the certification in b2bconsole to finish the CDE E2B submission

As of May 1, 2018, serious and unexpected adverse drug reactions reported during the clinical study of the drug apply to "E2A: Management of Clinical Safety Data: Definitions and Criteria for Fast Reporting" "M1: MedDRA )"And" E2B (R3): Management of Clinical Safety Data: Data Elements for Individual Safety Report Transmission.

We are doing testing with CDE tech people, and CDE provided an SSL certification file(p7b) and an EDI certification file(CER).
We also need to receive accept/reject message from CDE, so we need to generate an SSL certification file(p7b) and an EDI certification file(CER) to CDE also.
The questions are
1)how to configure the 2 certification files from CDE on our side?
2)Do we also need to configure 2 certification files which are generated by us? and how to configure?


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