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 as Reported	Enter the verbatim drug name. The field is free text and editable in case form. During book-in, if you leave the Product Name field blank and tab out, then the data entered in Product Name as Reported is copied into the mandatory Product Name field. The data entered in this field during book-in are availailable in this field. If the Product Name as Reported field is left blank, then the case form also displays it as blank. For a spontaneous case and a non-company study case: If you enter data in both the Product Name and Product Name as Reported fields, then both fields are editable and data is captured individually. When you enter a product name by either copying it from the Product Name as Reported field or you enter it manually, then the Product Name field is not overwritten with data from Product Name as Reported. For a sponsored trial case: After the study is populated, the Product Name as Reported becomes read only. For blinded and non-blinded study cases, the field is read only.
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 you enter data in the Product Name as Reported field, then the Product Name field is automatically populated. 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. When blinded treatment groups are configured in study configuration, the Add Blinded Treatment Group menu and Treatment Group field are available in the Products tab. The maximum number of treatment groups you can add to the case by using the Add Blinded Treatment Group option is equal to the total number configured in the study configuration. Once a case is created, the Treatment Group dropdown is blank by default. When visible, this field is mandatory. Once you select a Treatment Group, the Product Name as Reported, Product Name and Generic Name fields are updated.
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 Type	Auto-populates based on the selected license in the Argus Console > Studies Configuration > Product > License drop down. This field is populated only for the new cases being created and on reselecting the products. For the existing cases, this field is not updated and remains the same unless a product is selected again. Not even if configured in Argus Console. If the selected license does not have Product Identifier Type in Console, then this field remains blank. If a License’s Product Identifier Type is changed in Console and saved, the cases with that license does not reflect the new value unless the product is reselected.
Product Identifier	Auto-populates based on the selected license in the Argus Console > Studies Configuration > Product > License drop down. This field is populated only for the new cases being created and on reselecting the products. For the existing cases, this field is not updated and remains the same unless a product is selected again. Not even if configured in Argus Console. If the selected license does not have Product Identifier in Console, then this field remains blank. If a License’s Product Identifier is changed in Console and saved, the cases with that license does not reflect the new value unless the product is reselected.
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. Blinded text is displayed for this field for blinded study cases and for users who have marked the Protect from Unblinded Information check box (protected user).
Drug Code	Enter the WHO-DRUG code.
WHO Medicinal Product ID	Displays the Medicinal Product ID associated with the selected WHO drug. For company products, this field is updated based on the data available in license configuration. If not available, this field is updated based on the data available in product configuration. For non-company products, this field is updated based on the selected WHO Drug.
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. Blinded text is displayed for this field for blinded study cases and for users who have marked the Protect from Unblinded Information check box (protected user).
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. Blinded text is displayed for this field for blinded study cases and for users who have marked the Protect from Unblinded Information check box (protected user).
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. Blinded text is displayed for this field for blinded study cases and for users who have marked the Protect from Unblinded Information check box (protected user).
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.
Treatment Group	Indicates the blinded treatment groups as configured in Console. When visible, this field is mandatory. The following error message is displayed when you save a case without selecting a treatment group: Treatment Group must be entered for blinded case. When the Add Blinded Treatment Group menu option is used, then a new Product tab is created with the same data that the system added during case creation, including a blank Treatment Group field.
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.