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Inaccurate Listing of Ingredient Details Presented in Substance Information Section of Product Tab in a Study Case (Doc ID 3005846.1)

Last updated on FEBRUARY 22, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.1 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Symptoms

The user has configured a study, labeled as "STUDY A," which comprises two arms:

1. Arm 1: Not blinded
2. Arm 2: Double-blinded

Within this study, the following products have been included in both arms:

1. Product A (Investigational Product)
2. Product B (Comparator)

These two products belong to distinct Product Families and contain the following ingredients:

1. Product A, belonging to Product Family 1, contains the following ingredients:
- INGREDIENT 1
- INGREDIENT 2
- INGREDIENT 3
- INGREDIENT 4

2. Product B, belonging to Product Family 2, contains the following ingredients:
- INGREDIENT 1
- INGREDIENT 2
- INGREDIENT 5
- INGREDIENT 6

In the case of the aforementioned study, upon selecting the Study Drug as Product A within the Product tab, the system erroneously displays 6 ingredients instead of the correct count of 4 ingredients under the Substance Information section of the Product tab.

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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