Click the Ingredient tab to add the product ingredient details.
Click
Add.
A blank row gets added in the grid.
Select Primary Active to indicate that the ingredient is the primary active ingredient in the product.
Select
the Substance Name from the
associated product from the active substance lookup.
The substance indicates the active ingredient of the product.
Enter the Clinical Drug Code (CDC), i.e. the code for the product that is assigned and shared between the HQ and Affiliates of a Pharmaceutical company.
Enter the CAS number or use the CAS Number Lookup, to capture the CAS number and the Substance Name of the drug i.e the unique number assigned to every chemical substance by Chemical Abstracts Service (CAS).
Enter the Strength of the ingredient.
Select the unit of Strength from the drop-down list.
Select the Manual check box to enter the ingredients of the product manually or automatically code when the CPD is used.
Enter the TermID which is an identifier assigned at the level of each term of the controlled vocabulary.
Enter the TermID operation date which was operational.
Enter the Class of ingredient from the drop-down list. The options include:
Pharmaceutical product
Non-Pharmaceutical
product: For Example: Hygiene products, cosmetics
This information gets printed in the management reports like the AER
data report, Overview report and Audit trial report.
Select the KDD ingredient code (G.k.2.3.r.1.KR.1b ) by using the Lookup. The lookup displays Ingredient Name in Korea, English and the Ingredient code.
Select
the KDD ingredient from the search results, the application displays
the Korean ingredient code and ingredient name in Korean Language
in the Ingredients grid.
Note: The KDD Ingredient field
supports autocode i.e., on manually entering KDD Ingredient code,
the respective decode in Korean language gets populated.
KDD Ingredient and KDD Ingredient name also supports autocode, study
copy products, Batch autocode and Batch AER update from all the levels.
The KDD Ingredient and KDD Ingredient name in the Ingredients tab is also available in FDE, ISP, Korean and Unblind screens.
Korean Drug Dictionary is also available in FDE, ISP, Korean and Unblind screen.
When you select product from the Japanese Drug Lookup, the generic name of the English and Japanese is automatically retrieved and displayed in the English decode and Japanese decode fields, respectively. Also, the substance values are automatically retrieved and displayed in the Substance Name (B.4.k.2.2/G.k.2.3.r.1/G.k.2.3.r.1.KR.1b) of the Ingredient tab.
NOTE:
In ARISj, the generic name of the Substance Name (B.4.k.2.2/G.k.2.3.r.1/G.k.2.3.r.1.KR.1b) value that is retrieved on selecting the product from the Japanese Drug Lookup is displayed in Japanese.
In ARISg, the generic name of the Substance Name (B.4.k.2.2/G.k.2.3.r.1) value that retrieved on selecting the product from the Japanese Drug Lookup is displayed in English.