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 Safety automatically populates the Relatedness field at the Case-level, for high visibility of the relatedness (causality) evaluation from the primary assessment and its Case Assessment Results.
Auto-Calculation Logic
The system uses the following logic to determine Case relatedness and populate the Relatedness field:
- Yes: (Related) Populated when the Causality Established field in any primary Assessment Result is set to Yes.
- No: (Unrelated) Populated when the Causality Established field in at least two primary Assessment Results is set to No, including one company assessment and one 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 the system to consider it as a company assessment.
- Unknown: Populated when the Causality Established field in all primary Assessment Results is unknown or unspecified, or when any primary Assessment Result is No and the remaining primary Assessment Result 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, the system re-calculates the Case Relatedness field.