How Case Assessment Expectedness is Generated

Vault assesses expectedness for each Case Assessment through generated Case Assessment Expectedness records.

About Expectedness

A Case Assessment Expectedness record identifies whether the MedDRA Term on a Case Adverse Event is considered expected on the corresponding Product Family, Product, Local, Study, or Study Product Datasheet. Depending on your Admin’s configuration, Vault can also:

  • Generate Expectedness records for blinded Study Products on Cases for double-blinded clinical trial Studies without Study Arms.
  • Copy the rationale for adverse event expectedness evaluations from the Datasheet to Case Assessment Expectedness and Localized Case Assessment records.

Learn more about configurable options for evaluating expectedness on clinical trial study Cases.

Case Assessment Expectedness records are generated for each of the following Datasheet sources associated with the Case Product in the Case Assessment.

Source Expectedness Generation
Product Family Datasheet If an assessment's Case Product inherits a Datasheet from the Product Family, Vault generates a Case Assessment Expectedness record for the Datasheet.
Product Core Datasheet If an assessment's Case Product has a core Datasheet, Vault generates a Case Assessment Expectedness record for the core Datasheet.
Study Core Datasheet When the assessment's Case Product is of the type Study Product, and if the Study Product Role is Investigational, Vault generates a Case Assessment Expectedness record for the Study's core Datasheet.
Local Datasheets Vault generates Case Assessment Expectedness records for each Case Product Registration with a local Datasheet. Admins can configure local Datasheet to inherit listed events from the core Datasheet.
Study Product Datasheet When the assessment's Case Product is of the type Study Product, Vault generates a Case Assessment Expectedness record for the study product Datasheet. Admins can configure study product Datasheets to inherit listed events from the study core Datasheet.

Vault links all Case Assessment Expectedness records to the source Datasheet and the latest version of the referenced datasheet document in the Library.

How Expectedness is Evaluated

When evaluating whether a Case Adverse Event is expected in relation to the Datasheet for the Case Product, Vault first checks whether the event MedDRA matches a term on the Datasheet. To be considered a match, the term must be listed on or fall under the hierarchy of a term on the Datasheet. Then, Vault performs a number of checks based on the precise expectedness and conditional expectedness settings on the Datasheet.

Learn how Vault evaluates a MedDRA term without specified demographics, with specified demographics, and for clinical trial study Cases.

Expectedness Evaluations Without Demographics

The following flowchart illustrates how Vault evaluates Case Assessment Expectedness. The green components show the precise expectedness evaluation, while the orange components show the conditional expectedness evaluation:

Expectedness Evaluation Logic

The following table outlines the different expectedness scenarios, based on the Datasheet settings and MedDRA Criteria settings for the event term:

Term Matched on Datasheet? Datasheet MedDRA Criteria Case Assessment Expectedness
Precise Expectedness Enabled? Unexpected Seriousness Criteria Expectedness Seriousness Exclusion
Yes N/A Blank Expected 1 Blank Yes
Yes N/A N/A2 Expected Yes: not matching 3 Yes
Yes N/A Yes: not matching 3 Expected Blank Yes
Yes N/A N/A2 Expected Yes: matching 3 No
Yes N/A Yes: matching 3 Expected Blank No
Yes N/A N/A Unexpected N/A No
No No N/A N/A N/A No
No Yes N/A N/A N/A Blank
1. If "Expectedness" is not defined, the value defaults to Expected.
2. When "Seriousness Exclusion" is defined on a MedDRA Criteria record, this setting takes precedence and the Datasheet's "Unexpected Seriousness Criteria" setting is ignored.
3. Matching refers to whether the Case Adverse Event has one (1) or more Seriousness values that match a Seriousness condition defined on the Datasheet or MedDRA Criteria.

Expectedness Evaluations With Demographics

Expectedness evaluations in Vault support age and sex criteria. This enables creating more precise product Datasheets for adverse events that affect specific demographics.

When matching patient details to MedDRA Criteria terms on Datasheets, Vault prioritizes the Expected/Unexpected Event Terms record with the most details. For example, if a Datasheet includes the same MedDRA Criteria term, once with sex as the only demographic detail and once with sex and age range specified, Vault matches Case Adverse Events using the second, more detailed, record.

When matching based on sex, if the Case specifies the Patient’s sex, Vault matches to MedDRA Criteria terms on the Datasheet that include that sex if such a record exists. If the MedDRA Criteria term appears on the Datasheet without a specified sex, Vault matches if all other criteria match the details on the Case.

When matching based on age, Vault matches the patient’s age to the age range of the adverse event on the Datasheet using the following priority order:

  1. Age at Onset calculated using the Onset date of the Case Adverse Event and the Date of Birth in the Patient section. If those values are not available, Vault maps from the manually populated Age at Onset in the Patient section.
    If the Age at Onset value uses Decades as the unit, Vault considers both the lower and upper bounds of the decade when evaluating expectedness. For example, if the patient’s age is entered using 2 in the Number field and Decade in the Unit field, indicating they are between 10–20 years old, and the adverse event on the Datasheet is expected only for patients with an age range of 2–12 years old, Vault considers this adverse event unexpected since the upper bound of the decade (age 20) is outside the expected age range.
  2. Age Group based on the Age Group Controlled Vocabulary type. When matching is based on Age Group, the Patient Age Group must fall entirely within the age range on the Datasheet. The following table provides examples of when Vault matches the Patient Age Group to the age range of the adverse event on the Datasheet.
Patient Age Group
(Controlled Vocabulary Age Range)		 Datasheet Age Range Expectedness Match?
Child (2–11 years old) Age Range Start: 2 years
Age Range End: 20 years		 Matched
Adolescent (12–17 years old) Age Range Start: 5 years
Age Range End: 15 years		 Not matched
Adolescent (12–17 years old) Age Range Start: 5 years
Age Range End: 20 years		 Matched
Adult (18–64 years old) Age Range Start: 35 years
Age Range End: 55 years		 Not matched
Elderly (65+ years old) Age Range Start: 60 years
Age Range End: blank		 Matched

Expectedness Evaluations for Clinical Trial Study Cases

Learn more about expectedness evaluations for clinical trial study Cases.

How-To Videos: Understanding Expectedness Evaluations

Watch our quick video tutorials on Understanding Expectedness Evaluations and Understanding Precise Expectedness Evaluations.

When is Expectedness Evaluated

Vault evaluates expectedness upon Case creation and aggregate report generation. Vault reevaluates expectedness when any of the following related fields are updated on a Case record:

  • Case Assessment
  • Case Adverse Event
  • Case Product
  • Case Patient Sex
  • Case Patient Age (including Date of Birth, Age at Onset, or Age Group)

For clinical trial study Cases, expectedness is also reevaluated when the related Case Adverse Event Onset date is updated. If your Admin has enabled Datasheet Expectedness for Blinded Study Products, Vault also reevaluates expectedness when you modify the Blinded Name field on a Case Product.

When reevaluating expectedness, Vault replaces the previous system-generated Case Assessment Expectedness records with new records.

The following table provides more information:

Object or Field Conditions
Case

Vault evaluates expectedness upon Case promotion.

For follow-Up Cases, Case Assessment Expectedness records are copied from the previous Case version. Expectedness is not reevaluated unless the Case Adverse Event Seriousness or MedDRA Term (Event MedDRA) changed in the new version. For clinical trial study Cases, Vault also reevaluates expectedness if the Adverse Event Onset Date changes.
Case Assessment Vault evaluates expectedness when a Case Assessment is created or updated.
Case Adverse Event

Vault evaluates expectedness when a Case Adverse Event related to a Case Assessment is created or either of the following fields are modified:

  • MedDRA Term (Event MedDRA)
  • Seriousness
Case Product

Vault evaluates expectedness when a Case Product with an eligible Drug Role related to a Case Assessment is created or the linked Product or Study Product is updated.

If your Admin has enabled Datasheet Expectedness for Blinded Study Products, Vault also reevaluates expectedness when you modify the Blinded Name field.
Case Product Indication Vault evaluates expectedness when an Indication under the Case Product related to a Case Assessment is created or the Indication (Reported) field is updated.
Case Patient Sex Vault evaluates expectedness when the patient's Sex is added, changed, or deleted.
Case Patient Age

Vault evaluates expectedness when any of the following age-related fields on the Case are added, updated, or deleted:

  • Date of Birth
  • Age at Onset
  • Age Group
  • Adverse Event Onset