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Combination Product of Drug and Device not behaving as expected when Blind is broken (Doc ID 2808715.1)

Last updated on SEPTEMBER 29, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.


User has created a Blinded Study with a Drug+Device Combination product. When a case is logged with that study and the product tab is checked you can see the product correctly has the drug+device combination. However, when the blind is broken by sponsor, the combination product no longer appears the same. You only get the individual product appear depending on what is selected in the Study drug in the drop down.

Steps to Repeat:
1. Create a double blinded study with a drug and device - both blinded
2. Create the Combination product in Flex Cat for this drug and device
3. Create a new case for this study
4. Go to Product tab and you can correctly see the combination product
5. Go to General tab and change the Blinding Status to Broken by Sponsor
6. Go back to Products tab and you can see that combination product does not appear as a combo any more. You only get the individual product appear depending on what is selected in the Study drug in the drop down.



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