Product information—field descriptions

This section enables you to enter information about the drug being used for the case.

Table 2-2 Product Information

Field or Control Name	Description
Product Name	Enter the name of the product using the Select button or by entering a partial product name. Type a partial product name and press TAB. This displays the Product Selection dialog box. If only one product is found, this information is entered without showing the dialog box. If no match is found in the company product list, the WHO Drug Dictionary is searched for a possible match through the WHO Drug Dictionary dialog box. If a match is still not found, the text you initially typed in, is used as is. If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown. This field supports multiple language entries. Click the multi-language icon to display the languages window, select the target language from the drop-down list at the top, and enter the text in the language fields. Note: Editing the base entry in English/Japanese is disabled for product names.
Select	Displays the product selection dialog box. Select a product from the list of company products click Select. The relevant fields are added to the Case Form.
Encode	Click Encode to retrieve the code.
Suspect Concomitant Treatment/Other	Make a selection for the product you are entering. The drug types indicate the involvement of the product with the adverse event(s) reported for the case. Suspect indicates that the product may have caused the adverse event(s). Concomitant indicates drugs that are taken with the suspect drug. Treatment/Other is the drug taken to treat the adverse event.
Generic Name	Enter the generic name of the drug in a manner similar to the Product Name. If the study is blinded, the Generic Name is replaced with the Study Name of the product. Note: This name is entered based on the selected company product. If the study is blinded, the Blinded Name of the clinical study is displayed in this field. After unblinding, the selected study's Product Name for Unblinded cases is not shown. This field supports multiple language entries. Click the multi-language icon to display the languages window, select the target language from the drop-down list at the top, and enter the text in the language fields. Note: Editing the base entry in English/Japanese is disabled for generic names.
Product Identifier	Displays the type of Product Identifier such as MPID, PhPID, and so on.
MFDS Product Code	Enables you to enter the MFDS product code for the drug. This field is treated as a blinded field.
OTC Product	Check this check box if the product administered was an over-the-counter (OTC) product.
Pre-1938	For non-company products, enter the data. For company products, this field is updated based on the data available in the license configuration and is ready-only. For study products, this field is fetched based on the primary license number selected in the Console > Studies Configuration. When unblinded at case level, data is enabled irrespective of the product selected in the Study Drug drop-down. Note: The Pre-1938 field available under the Case Form > Analysis > MedWatch tab will not be used in eMDR.
Biosimilar	For non-company products, enter the data. For company products, this field is updated based on the data available in the license configuration and is ready-only. For study products, this field is fetched based on the primary license number selected in the Console > Studies Configuration. When unblinded at case level, data is enabled irrespective of the product selected in the Study Drug drop-down.
Compounded Product	Check this check box if the product administered was compounded.
Company Drug Code	Displays the licensed country for the selected company product.
Obtain Drug Country	Country the drug is licensed in.
Drug Code	Enter the WHO-DRUG code.
WHO Medicinal Product ID	Displays the Medicinal ID associated with the selected WHO drug. The WHO Drug code used to identify the drug. Note: This ID is populated only if a WHO-drug is selected.
Formulation	Select the formulation of the product. The form in which the drug was administered (liquid, tablet, capsule, and so on.) Note: This field is entered based on the product. Contact your administrator to adjust this list.
Drug Authorization Country	The country where the drug is licensed.
Market Authorization Holder	Captures the name of the Marketing Authorization Holder of the product that was administered. Note: For study products, this field is fetched based on the primary license number selected in the Console > Business Configuration > Studies > Product > License drop-down list.
Authorization Type	Captures the Authorization Type of the product that was administered such as IND, BLA, PLA, and so on. Note: The Authorization Type field length was changed from 5 to 10 characters. For study products, this field is fetched based on the primary license number selected in the Console > Business Configuration > Studies > Product > License drop-down list.
Authorization Number	Captures the Authorization Number or License Number of the product that was administered. Note: For study products, this field is fetched based on the primary license number selected in the Console > Business Configuration > Studies > Product > License drop-down list.
Authorized Representative	Select a manufacturer name from the manufacture codelist.
Manufacturer	A different Manufacturer can be selected from the drop-down list and can still be kept as a company product.
Concentration	Indicates the amount of the drug that was administered. After a drug and formulation have been entered, select the concentration from the list, or enter the concentration. If this information is changed manually, the product is marked as a non-company product. Note: This field is entered based on the chosen product. The concentration cannot be modified for a Study drug.
Interaction?	Indicates whether the case involves a drug interaction.
Contraindicated?	Indicates whether the drug was administered contrary to its indication.
Drug Not Administered	Check this check box if no drug was administered on the patient.

Table 2-3 Substance Information

Field or Control Name	Description
Substance Name	Displays the Ingredient's name.
Strength	The Strength of the substance used in the Product.
Unit	The drug unit (such as mg, tsp, and so on).
MFDS Ingredient Code	Enables you to enter the MFDS ingredient code for the drug. This field is treated as a blinded field.

Note:

Drug Authorization Country, Authorization Type, Authorization Number, and Marketing Authorization Holder data are populated from the Argus Console for company products.

For Study Products, the system populates the Authorization Type, Authorization Number, and Marketing Authorization Holder data based on the Primary license number selected in the Argus Console > Studies Configuration. When unblinded at the case level, Authorization Type and Authorization Number data is not accessible for users with restricted access to unblinded data.

The application supports printing of the new fields added to the Product Information tab.