# Enable Agency-Based Auto-Expectedness for Clinical Trial Study Cases

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 <a href="/en/lr/01213/#base-ct-expectedness-on">Manage Organizations</a>. To learn more about how Vault evaluates expectedness based on an _Agency's_ settings, see <a href="/en/lr/822874/#date-based">Expectedness Evaluations for Clinical Trial Study Cases</a>.

## 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".

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      <p><strong>Note</strong>: If you enable this feature and configure any <em>Agency</em> with a value in the <em>Base Clinical Trial Expectedness On</em> field, and then want to turn off the feature, you must ensure that the <em>Base Clinical Trial Expectedness On</em> field is clear on all <em>Agency</em> records in your Vault.</p>
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## Recommendation

To best use this feature, we recommend that you also enable <a href="/en/lr/737261/">Show Calculation Basis for Clinical Trial Study Expectedness</a>.

## Update Safety General Settings

Complete the following steps to turn on this feature in your Vault:

1. Go to **Admin > Settings > Safety General Settings**.
2. Select **Edit**.
3. In the _Auto-generate Assessments_ section, select the **Calculate Clinical Trial Case Expectedness using "Based On" field** checkbox.
4. Select **Save**.

## Update the Organization Layout

Complete the following steps to add the _Base Clinical Trial Expectedness On_ field to _Agency_-type _Organizations_:

1. Go to **Admin > Configuration > Objects > Organization > Layouts > Agency Detail Page Layout**.
2. In the _Details_ section, add the **Base Clinical Trial Expectedness On** field.
3. Select **Save**.