Learn how to configure your Vault to customize expectedness evaluations on Clinical Trial Study Cases by Agency.
About the Feature
With this release, you can customize the basis of expectedness evaluations on Clinical Trial Study Cases depending on agency requirements. Previously, Vault always evaluated expectedness based on Case Adverse Event Onset dates, taking into consideration the active date range of the associated MedDRA Term on the applicable Datasheets. Now, you can specify for each Agency whether Vault uses Onset date or evaluates expectedness based on the New Info Date of Cases.
When expectedness is evaluated based on New Info Date, Vault does not consider the active date range of MedDRA Terms. For applicable Product Core Datasheets and Local Datasheets, Vault generates Expectedness records based on New Info Dates. For applicable Study Core Datasheets and Study Product Datasheeets, Vault generates Expectedness records based on both New Info Dates and Onset dates.
After configuring this feature, for more information on configuring Agency expectedness evaluation settings, see Manage Organizations. To learn more about how Vault evaluates expectedness based on an Agency’s settings, see How Case Assessment Expectedness is Generated.
Supported Configurations
The following Vault configurations are supported by this feature:
- In Safety General Settings, the Calculate Clinical Trial Case Expectedness using “Based On” field checkbox is clear and your Vault does not include any Agency records with the Base Clinical Trial Expectedness On field set to “New Info Date”.
- In Safety General Settings, the Calculate Clinical Trial Case Expectedness using “Based On” field checkbox is selected and your Vault does not include Agency records with the Base Clinical Trial Expectedness On field set to “New Info Date”.
- In Safety General Settings, the Calculate Clinical Trial Case Expectedness using “Based On” field checkbox is selected and your Vault includes one (1) or more Agency records with the Base Clinical Trial Expectedness On field set to “New Info Date”.
Note: If you enable this feature and configure any Agency with a value in the Base Clinical Trial Expectedness On field, and then want to turn off the feature, you must ensure that the Base Clinical Trial Expectedness On field is clear on all Agency records in your Vault.
Recommendation
To best use this feature, we recommend that you also enable Show Calculation Basis for Clinical Trial Study Expectedness.
Update Safety General Settings
Complete the following steps to turn on this feature in your Vault:
- Go to Admin > Settings > Safety General Settings.
- Select Edit.
- In the Auto-generate Assessments section, select the Calculate Clinical Trial Case Expectedness using “Based On” field checkbox.
- Select Save.
Update the Organization Layout
Complete the following steps to add the Base Clinical Trial Expectedness On field to Agency-type Organizations:
- Go to Admin > Configuration > Objects > Organization > Layouts > Agency Detail Page Layout.
- In the Details section, add the Base Clinical Trial Expectedness On field.
- Select Save.