Vault considers the causality of investigational products when determining the appropriate column for case counting in the Serious Adverse Events (SAE) tabulation on DSURs and PBRERs.
About Causality Established & Case Counting
If your Admin has enabled DSUR and PBRER Investigational Product Causality, Vault considers Study Product blinding, the Study Product Role, and the Causality Established field when determining the appropriate column for case counting when generating the Cumulative Tabulation of Serious Adverse Events From Clinical Trials for DSURs and PBRERs.
In the absence of causality, meaning the value is No on all Causality Established fields on all Case Assessment Results, Vault uses the following priority for case counts:
- The Study Product is blinded
- The Study Product Role is:
- Investigational
- Active Comparator
- Placebo
For example, if a Case includes two (2) Case Products, one (1) with a Study Product Role of Investigational and one (1) with a Study Product Role of Placebo, and both have No in the Causality Established field of the Case Assessment Results, Vault counts the Case in the Investigational Medicinal Product column of the report.
However, if causality exists only on a lower-priority Case Assessment Result, Vault overrides the standard priority order for case counts. For example, if a Case includes two (2) Case Products, one (1) with a Study Product Role of Investigational and one (1) with a Study Product Role of Placebo, and only the Case Assessment Result for the Placebo has Yes in the Causality Established field, Vault counts the Case in the Placebo column of the report.