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Handling Updates to Code System Version (CSV) in E2B R3 HL7 Files in Argus Safety (Doc ID 2335201.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.1 and later
Information in this document applies to any platform.

Goal

When regulation guidelines are published by regulatory authorities for E2B R3 submissions, there could be changes to the CodeSystemVersion (CSV). 

CodeSystemVersion is the version number in the E2B R3 HL7 file populated along with the Object Identifier (OID) of the data element, wherever applicable.

When CSV is revised by regulatory authorities, it becomes mandatory to use the updated CSV in the HL7 files. If not, it may lead to ICSR rejection.

For example, in the reference XML published by ICH as part of E2B(R3) IG Complete Package v1_04, the element N.1.1 'Type of Messages in Batch', <BATCHMESSAGETYPE>, is represented as:

Here CodeSystemVersion is 1.01.

The CodeSystemVersion was updated to 2.0 in the revised guidance published by ICH under Revision 5.02 as mentioned in the M2 ESTRI Code List for OID 2.16.840.1.113883.3.989.2.1.1.1.  In this situation, any E2B R3 ICSR generated should contain CodeSystemVersion = 2.0 for the OID 2.16.840.1.113883.3.989.2.1.1.1.

Solution

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