**Source URL:** https://safety.veevavault.help/en/lr/822874/index.md

# Expectedness Evaluations for Clinical Trial Study Cases

To support clinical trial study _Case_ reporting, Vault offers several configurable options for evaluating expectedness. This includes the ability to determine the [date basis for calculating expectedness by agency][1], [generate expectedness for blinded _Study Products_][2], and specify a [_Datasheet_ type for marketed products used in clinical trials by agency][3].

Learn more about <a href="/en/lr/737264/">how</a> and <a href="/en/lr/737264/#expectedness-when">when</a> Vault generates expectedness.

## Prerequisites

To use all of the features described on this page, your Admin must enable:

* <a href="/en/lr/737256/">Agency-Based Auto-Expectedness for Clinical Trial Study Cases</a>
* <a href="/en/lr/774366/">Datasheet Expectedness for Blinded Study Products</a>
  * This is available only in Vaults configured to <a href="/en/lr/691317/">Isolate Blinded Clinical Trial Information</a>
* <a href="/en/lr/822875/">Expectedness for Investigational-Marketed Study Products</a>

## Date-Based Expectedness Calculations by Agency {#date-based}

For each agency, your Admin can configure <a href="/en/lr/01213/#base-ct-expectedness-on">expectedness evaluations</a> for clinical trial study _Cases_ to be based on the _Onset_ date of _Case Adverse Events_ or the _New Info Date_ on _Cases_. Using this setting, Vault generates general and cross reports using the _Case Assessment Expectedness_ record with a _Based On_ value that matches the _Agency_ configuration. For example, if an _Agency_ is configured to base expectedness evaluations on the _New Info Date_ on _Cases_, Vault generates the report using the _Case Assessment Expectedness_ records where the _Based On_ field value is _New Info Date_.

For agencies without this setting configured, Vault evaluates expectedness using the _Onset_ date of _Case Adverse Events_.

### Expectedness Based on Case Adverse Event Onset Date

When clinical trial expectedness evaluations are based on adverse event onset, Vault considers whether the _Onset_ date of each _Case Adverse Event_ is within the active date range of the applicable <a href="/en/lr/01198/#create-criteria">MedDRA Term</a> on the _Datasheet_. Dates outside of the range are considered unexpected. If the MedDRA Term on the _Datasheet_ does not include an _Active End Date_, the term is considered to be expected to the present day. If there is no _Active Start Date_ or _Active End Date_, the term is always considered expected. If the _Onset_ date is blank on the _Case Adverse Event_, Vault uses the _Receipt Date_ on the _Case_ for the evaluation.

### Expectedness Based on Case New Info Date

When clinical trial expectedness evaluations are based on the _New Info Date_ of each _Case_, Vault does not consider the active date range of the <a href="/en/lr/01198/#create-criteria">MedDRA Term</a>. If a clinical trial study has at least one (1) _Study Registration_ with an _Agency_ set to this evaluation basis, when an _Inbox Item_ is promoted to a _Case_, Vault generates expectedness as follows:

* One (1) _Case Assessment Expectedness_ record based on the _New Info Date_ for each applicable product core _Datasheet_ and local _Datasheet_ for the _Product_ referenced by the _Study Product_.
* Two (2) _Case Assessment Expectedness_ records, one (1) based on _New Info Date_ and the other based on _Onset_ date, for each applicable study core _Datasheet_ and study product _Datasheet_.

### Follow-Up Scenarios

When promoting _Inbox Items_ to follow-up _Cases_, Vault reevaluates all _Expected_ values where the _Case Assessment Expectedness_ record is based on _New Info Date_. Where _Expected_ values are based on _Onset_ date or have been overridden, Vault copies the values to follow-up _Cases_ and does not reevaluate _Expected_ values.

### Manual Record Creation

In manually created _Case Assessment Expectedness_ records related to study core _Datasheets_ or study product _Datasheets_, Vault populates _Onset Date_ in the _Based On_ field. For any _Agency_ associated with a _Study Registration_ that is configured to base expectedness on _New Info Date_, Vault also creates _Case Assessment Expectedness_ records with the _Based On_ field set to _New Info Date_. For both record types, Vault sets the _Expected (status)_ field to _Overridden_.

For any other manually created _Case Assessment Expectedness_ records, Vault sets the _Based On_ field to _New Info Date_ and the _Expected (status)_ field to _Overridden_.

If you manually create a _Case Product_ record that is not for a _Study Product_, Vault generates _Case Assessment Expectedness_ records for the product core _Datasheet_ and local _Datasheet_ only.

### Additional Considerations

Vault does not automatically update the basis of expectedness evaluations in the following instances:

* For in-progress clinical trial study _Cases_ created before your Admin configured the Agency-Based Auto-Expectedness for Clinical Trial Study Cases feature.
* When merging an _Inbox Item_ to an in-progress clinical trial study _Case_ created before your Admin configured the feature.
* If your Admin changes the basis of expectedness evaluations for an _Agency_. For example, if your Admin updates an _Agency's_ evaluation basis from _New Info Date_ to _Onset Date_.  

However, if you promote an _Inbox Item_ for a clinical trial study to a follow-up _Case_, Vault automatically recalculates expectedness values on the follow-up _Case_ based on _Agency_ settings.

## Study Product Placeholder Expectedness {#study-product-placeholder-expectedness}

In Vaults with <a href="/en/lr/691317/">isolate blinded clinical trial information</a> and <a href="/en/lr/774366/">Datasheet Expectedness for Blinded Study Products</a> configured, you can <a href="/en/lr/01198/#assoc-datasheets">associate all _Datasheets_</a> on a double-blinded clinical trial _Study_ without _Study Arms_ with its _Study Product Placeholders_. This allows Medical Reviewers to access all relevant values from associated _Datasheets_, supporting comprehensive assessments during blinded _Case_ reviews.

Vault generates _Study Product Placeholder_ expectedness as follows:

* For each blinded _Case Product_ and _Adverse Event_ combination, Vault generates a _Case Assessment_, _Case Assessment Result_, and _Expectedness_ record based on each _Datasheet_ associated with the _Study Product Placeholder_. These records have the _Blinding Type_ set to _Blinded_. For information on expectedness roll-ups at the <em>Case</em>-level, see <a href="/en/lr/737265/#spp-roll-up">How Expectedness Rolls Up to Case Expectedness and Listedness</a>.
* If you change the _Expected_ value on a blinded _Expectedness_ record, Vault updates the _Expected (status)_ field to _Overridden_.

If the _Case_ is unblinded, Vault generates unblinded _Case Assessment_, _Case Assessment Result_, and _Expectedness_ records based on _Datasheets_ for the unblinded _Case Product_. The _Blinding Type_ on these records is _Unblinded_. Vault does not alter the blinded records. For information on switching between the blinded and unblinded views, see <a href="/en/lr/691317/#select-the-blinded-or-unblinded-view">Isolate Blinded Clinical Trial Information</a>.

### Based On Date Expectedness Calculation

When generating _Study Product Placeholder_ expectedness, Vault populates the <a href="/en/lr/01287/#based-on">_Based On_ field</a> on _Case Assessment Expectedness_ records based on whether a _Datasheet_ associated with a _Study Product Placeholder_ matches the study core or study product _Datasheet_ as follows:

* When there is a match, Vault generates two _Case Assessment Expectedness_ records: one with _Based On_ set to _Onset Date_ and the other set to _New Info Date_.
* When there is no match, Vault generates one _Case Assessment Expectedness_ record with _Based On_ set to _New Info Date_.

### Recalculate Expectedness

To recalculate expectedness:

1. On the applicable clinical trial study _Case_, for each _Case Assessment_, delete all existing **Expectedness** records.
2. In the **All Actions** menu, select **Generate Assessments**.

For more information on generating _Case Assessments_ for clinical trial study _Cases_, see <a href="/en/lr/01169/#ct-expectedness">Generate Assessments</a>.

## Expectedness for Investigational-Marketed Study Products {#inv-mkt-expectedness}

For each agency, your Admin can configure which <a href="/en/lr/01213/#inv-mkt-expectedness">_Datasheet_ type</a> should be used when selecting the expectedness of adverse events to evaluate the reportability of marketed products within the country of the agency when those products are used in clinical trial studies. This is useful for marketed products that have different datasheets when that product is used in an investigational study.

If the _Inv.-Marketed Product Expectedness_ field on an _Agency_ record is blank, Vault uses expectedness evaluations based on the study product _Datasheet_, if available, or the study core _Datasheet_ to determine reportability to that agency.

During both general and cross reporting, if there are multiple local _Datasheets_ for a country or multiple _Study Products_ that could be substituted for a product, Vault evaluates all available expectedness values and generates reports based on the most conservative value.

 <div class="note-border alert-info">
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      <p><strong>Note</strong>: As <a href="/en/lr/01215/#unknown-formulation-products">unknown formulation <em>Products</em></a> do not include <em>Product Registrations</em>, Vault is unable to determine with certainty if the <em>Product</em> is registered (marketed) within a certain region. As a result, for unknown formulation <em>Products</em> being used in an Investigational-Marketed context, Vault always uses the <a href="/en/lr/737264/">investigational expectedness</a>.</p>
    </div>
  </div>
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### General Reporting {#general-reporting}

When users run the _Evaluate Reporting Obligations_ action on a clinical trial study _Case_, only for the marketed products within the country of the agency being evaluated, Vault considers the _Datasheet type_ configured in the _Inv.-Marketed Product Expectedness_ field of the _Agency_ record. Based on the value, Vault selects which expectedness record to use when evaluating reportability for that product to the applicable agency.

When the _Inv.-Marketed Product Expectedness_ field value is:

* Blank or _Investigational Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * _Case Assessment Expectedness_ records generated from the study product _Datasheet_
  * _Case Assessment Expectedness_ records generated from the study core _Datasheet_
  * _Case Assessment_ records
* _Postmarket Local Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * _Case Assessment Expectedness_ records generated from local _Datasheets_ for the same agency
  * _Case Assessment Expectedness_ records generated from study product _Datasheets_
  * _Case Assessment Expectedness_ records generated from study core _Datasheets_
  * _Case Assessment_ records
* _Postmarket Core Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * _Case Assessment Expectedness_ records generated from product core _Datasheets_
  * _Case Assessment Expectedness_ records generated from study product _Datasheets_
  * _Case Assessment Expectedness_ records generated from study core _Datasheets_
  * _Case Assessment_ records

### Cross Reporting

When users run the _Evaluate Reporting Obligations_ action on a clinical trial study _Case_, to evaluate cross reporting obligations Vault first considers your Admin's configuration of the <a href="/en/lr/01425/">Cross Reporting without Datasheet Expectedness Substitution</a> setting. For information on this feature, see <a href="/en/lr/01247/#cr-eval-of-expectedness-rp">Cross Reporting</a>.

If your Admin has enabled the setting, the rule engine calculates expectedness in the same way as for [general reporting][4].

If your Admin has not enabled the setting, when cross reporting for an investigational study registration, only for the marketed products within the country of the agency being evaluated, Vault considers the _Datasheet_ type configured in the _Inv.-Marketed Product Expectedness_ field of the _Agency_ record. Based on the value, Vault selects which expectedness record to use when evaluating reportability for that product to the applicable agency.

When the _Inv.-Marketed Product Expectedness_ field value is:

* Blank or _Investigational Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * Study product _Datasheet_ for the substituted product
  * Study core _Datasheet_ for the study that contains the substituted product
  * _Case Assessment_ records
* _Postmarket Local Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * Local _Datasheets_ for the same agency for the substituted product
  * Study product _Datasheets_ for the substituted product
  * Study core _Datasheets_ for the study that contains the substituted product
  * _Case Assessment_ records
* _Postmarket Core Datasheet_: Vault generates reports based on the following sources, listed in priority order:
  * Product core _Datasheets_ for the substituted product
  * Study product _Datasheets_ for the substituted product
  * Study core _Datasheets_ for the study that contains the substituted product
  * _Case Assessment_ records

[1]: #date-based
[2]: #study-product-placeholder-expectedness
[3]: #inv-mkt-expectedness
[4]: #general-reporting