Expectedness Evaluations for Clinical Trial Study Cases

Learn about Vault’s options related to expectedness evaluations for clinical trial study Cases.

About Clinical Trial Study Case Expectedness

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, generate expectedness for blinded Study Products, and specify a Datasheet type for marketed products used in clinical trials by agency.

Learn more about how and when Vault generates expectedness.

Prerequisites

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

Date-Based Expectedness Calculations by Agency

For each agency, your Admin can configure expectedness evaluations 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 MedDRA Term 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 MedDRA Term. 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

In Vaults with isolate blinded clinical trial information and Datasheet Expectedness for Blinded Study Products configured, you can associate all Datasheets 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 Case-level, see How Expectedness Rolls Up to Case Expectedness and Listedness.
  • 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 Isolate Blinded Clinical Trial Information.

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 Generate Assessments.

Expectedness for Investigational-Marketed Study Products

For each agency, your Admin can configure which Datasheet type 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.

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 Cross Reporting without Datasheet Expectedness Substitution setting. For information on this feature, see Cross Reporting.

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

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