Configuring Assessments

This screen enables you to configure the case processing fields and items for assessments. Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To view the list of field names associated with the Case Processing > Assessments section, click the Assessments folder in the left panel.

The field names associated with Assessments Configuration appear in the right panel.

Field Descriptions

The following table lists the fields available under Assessments Configuration:

Field or Control Name	Description
Display warning when Case Level Assessment does not match with Event Level Assessment	The available options are Yes and No.
Criteria for case level causality assessment	The available options are: Derive the case level causality based on the As Determined event level causality. Manually select case level causality.
Criteria for case level Seriousness determination	The available options are: Derive the case level seriousness based on the events. If any event is serious, case level will be serious. Manually select case level seriousness.
SUSAR Criteria	Enables you to enter an SUSAR criteria as an SQL query. An SUSAR is identified as a Serious, Unexpected, Related Case. Note: The SQL should not exceed 2000 characters.
Criteria for Event Level Assessment for Blinded Study	You can indicate if event assessment is required for all the blinded products configured in Study Configuration. The available options are: Include datasheet/licenses for all the blinded study products Include datasheet/licenses for the default blinded study product By default, this switch is set to Include datasheet/licenses for the default blinded study product. Note: If you have the Include datasheet/licenses for all the blinded products option set to perform assessment and if you use the same datasheet names across multiple study products, it might be difficult to distinguish between each study products in the Event Assessment section. If you want to identify products based on datasheets, it is recommended to revise the datasheet names to include product name/identifier.

Use the following procedure to Configure the Case Processing Options

1. Select the required option for Display warning when Case Level Assessment does not match with Event Level Assessment.
2. Select the required option for Criteria for case level causality assessment.
3. Select the required option for Criteria for case level Seriousness determination.
4. Enter the SUSAR Criteria.
5. Click Save to save the changes made.