Enter product indications on the drug tab

Enter information about the indicator of the adverse event, like:

  • Reported Indication—Reported reaction
  • Coded Indication—Code for the reaction

Both values could be different or the same.

Table 2-3 Product Indication—Field Description

Field/Control Name Description

Reported Indication

By default, the value of this field is populated with the Product Indication from the Product Configuration, if set up. If not, you can enter a term into the Reported Indication field.

Note:

Oracle Argus Safety automatically encodes this information. You can also click Encode to open the coding dictionary dialog box.

If you update a study drug in case form, refresh the Primary Indication as well, as per the selected study drug. You can then add, update or delete these indications.

Coded Indication

This field is populated with the encoded term when you enter data in the reported indication field and tabs out.

Encode (Indication)

Opens the MedDRA Browser with the term already populated from the Coded Indication field.

To view the complete MEDDRA hierarchy for the encoded term, click the Encoding Status icon.

Add

Adds a new Indication row.

Only two indications are visible at a time

Delete

Click this button to delete the selected Indication row.

Update Click this button to update the selected Indication row.