Field Descriptions

The following table describes the fields associated with this section.

Field or Control Name Description

Field Name

Enables you to view the field name. This is a read only field.

Field Form Label

Enables you to enter the field label names for those fields that can be edited.

Help Text

Enables you to enter help text for fields that can be edited.

Read Only

Enables you to make drug, device, or vaccine field read- only.

Drug

Enables you to make a field Read only in the Product tab, when the Oracle Argus Safety user chooses Drug option on the Product screen.

Device

Enables you to make a field Read only in the Product tab, when the Oracle Argus Safety user chooses Device option on Product screen.

Vaccine

Enables you to make a field Read only in the Product tab, when the Oracle Argus Safety user chooses Vaccine option on Product screen.

Hidden

Enables you to hide or unhide a field by selecting the radio button.

Select Yes to hide the field on case form; select No to unhide the field on case form.

Note:

Some fields cannot be hidden. Hidden fields do not appear in the case form printout.

ICSR Field

When checked, displays which fields are required for E2B reports.

Max Length

Displays the maximum data length allowed for the fields. This information is displayed for all fields except for Date and Codelist fields.

Null Flavors

This drop-down list displays the Null Flavor sets that are configured in Null Flavor codelist. Null Flavors are displayed in the Case Form field as per Null Flavor set associated.

* Safe Length

Allows you configure the safe length for all fields except for Date and Codelist fields. Safe length is populated by default for E2B R2 fields which have been extended as per the E2B R3 Regulation.

This field is not used in the application for this release.

Selectable

When checked, it allows you to add or delete values when you select a numerical UDF.

When unchecked, the system deletes the existing values when you click Save.

Parent Dropdown

Allows you to configure the parent-child dependency of User Defined Number fields from the same table. For child user defined number fields, each child field can have only one parent field.

If the Parent Dropdown field is not selected in the child field configuration screen, then no dependancy is established.

One Parent field can be tied to multiple child fields.

This field is enabled when the Selectable checkbox is set.

This field is set to blank by default.

Category This column allows you to define a value that ties the parent and child records together.

This is set to blank as a default and is a free-text field, with a limit of 20 characters.

Use the following to modify case form field names.

  1. Select the folder (or section) in the left pane, for which the field names are to be modified.
  2. The places the list of field labels associated in the right panel.
  3. Click the Field Name to be modified.
  4. The system highlights the selected row is highlighted and puts the details about this field in the Modify section at the bottom of the screen.
  5. Enter the new field name in Field Form Label.

    Tip:

    This label will appear in the Case Form section.
  6. Select the Hidden preference. Select Yes if you want to hide the field on the Case Form.
  7. Click ICSR Field checkbox to indicate which fields are required for E2B.
  8. Select any or all of the following options Drug, Device or Vaccine as Read Only based on your requirement.
  9. Click Save to save the changes made.

Note:

Label changes will not be reflected in the Oracle Argus Safety Case Form unless IIS is reset.