Incorrect Product Tabs Were Displayed After Importing Study ICSR (Doc ID 2771828.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

Issue:

On 8.1.2

Incorrect product tabs were displayed after accepting the imported ICSR (xml file) with the blind study information.

Issue:#1: Open labeled study product does not populate in the the case product tab.

Expected behavior is that all the open labeled study product supposed to populate in the case product tab.

Issue:#2: The value of <medicinalproduct> in ICSR has been coded with the license in Argus Console. Therefore the license name from Argus Console is populated in the case product tab.

Expected behavior is that the value of <medicinalproduct> from ICSR file supposed to populate in the case product tab if there is a valid license for the country exists in console.

Note:

This issue does not occur in 8.2.2.

Steps to replicate the issue:

There is a ICSR file which has the trial case with the study information (say STUDY001).

In Argus Console > Business configuration > Studies,
this STUDY001 is configured as blind study with two study products (say PROD-A and PROD-B).
PROD-A is the blind study product and PROD-B is the open labeled product (the blind check box is unchecked).

In Argus Console > Business configuration > Products and Licenses,
product "PROD-A" has a license for USA and the product "PROD-B" has a license for TAIWAN (e.g., trade name:TWINV-B).

In ICSR file, the following 2 <drug> sections exist and both products are the study product for STUDY001.

-----------------------------------
<primarysourcecountry>TW</primarysourcecountry>
<occurcountry>TW</occurcountry>
(...)
<drug>
      <drugcharacterization>1</drugcharacterization>
      <medicinalproduct>PROD-A</medicinalproduct> --------- This is the one of study products for STUDY001.
(...)
</drug>
<drug>
      <drugcharacterization>1</drugcharacterization>
      <medicinalproduct>PROD-B</medicinalproduct> --------- This is the other study products for STUDY001.
-----------------------------------

Note that in this ICSR, B.4.k.2.2 <Activesubstnacename> does not exist in <drug> section.

If the <primarysourcecountry> in ICSR file is TAIWAN, the following products are popluated in case product tab after importing/accepting this ICSR file.

1st tab: "STUDY001" which is the study name
2nd tab: PROD-A
3rd tab: TWINV-B

Expected behavior is that following products are populated in the product tab.
1st tab:  "STUDY001" which is the study name
2nd tab: "PROD-B" which is the opened labeled study product
3rd tab: "PROD-A" which is the value of <medicinalproduct> in ICSR
4th tab: "PROD-B" which is the value of <medicinalproduct> in ICSR

Cause

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