G.k.4.r.9.1/G.k.4.r.9.2b (Formulation) Data is not Imported Correctly for Company and Non Company Products
(Doc ID 2997582.1)
Last updated on JANUARY 22, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.4 and laterInformation in this document applies to any platform.
Symptoms
Formulation is not loading as expected post R3 import for Non company products in 8.4. Ideally as per EMA R3 Import mapping, value of G.k.4.r.9.2b is compared against the EDQM Term ID value configured under Codelist>Formulation.
If there is a match then respective Formulation from Formulation codelist is populated to the destination field - Products Tab>Formulation.
If there is no matching formulation present in EDQM_REPOSITORY for G.k.4.r.9.2b then formulation shall be derived based on G.k.4.r.9.1.
Example - When user tries to import an R3 file with following values -
Product: Any WHO drug product (coded from WHO DD as concomitant drug)
R3 file contents -
G.k.4.r.9.1: Tablet
G.k.4.r.9.2b: PDF-10219000
EDQM value configured in console>Formulation>Tablet= PDF-10219000
Following is seen in the Products tab of case form post acceptance-
Formulation: Capsule
Expected Formulation:Tablet
Steps to Repeat:
---------------------
1)Import R3 file that contains products not configured in the company dictionary
2)Post acceptance verify if the formulation in the Products>Formulation for the non company product is same as formulation corresponding to the EDQM Term
ID in R3 file>G.k.4.r.9.2b
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |