Vault Safety automatically calculates the relatedness determination for an entire Vault Safety Case.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Case-Level Relatedness
Vault populates the Relatedness field in the Details section of Cases. This provides high visibility of the relatedness (causality) evaluation from the primary Case Assessment and its Case Assessment Results. Vault considers the Case Assessment with 1 in the Rank field to be the primary Case Assessment. Vault considers Case Assessment Results to be primary when they are associated with the primary Case Assessment.
Auto-Calculation Logic
Vault uses the following logic to determine Case relatedness and populate the Relatedness field:
- Yes: (Related) Populated when the Causality Established field in any primary Case Assessment Result is set to Yes.
- No: (Unrelated) Populated when the Causality Established field in at least two (2) primary Case Assessment Results is set to No, including one (1) company assessment and one (1) reporter’s assessment.
Note: For any custom source types, the E2B code in the custom Controlled Vocabulary record must be set to 2 (sponsor) or 4 (MAH) for Vault to consider it a company assessment.
- Unknown: Populated when the Causality Established field in all primary Case Assessment Results is unknown or unspecified, or when any primary Case Assessment Result is No and the remaining primary Case Assessment Results are unknown or unspecified.
Note: When assessing Combination Products, the Case relatedness is based on the drug or biologic constituent. The device constituent relatedness is not assessed.
How to Trigger Auto-Calculation
Any time the Causality Established field on a primary Case Assessment is updated, Vault re-calculates the Relatedness field in the Details section of the Case.
Relatedness Examples Animation
For more information on how Vault evaluates relatedness at the Case-level, use this interactive animation.