# Investigational Product Causality on SAE Tabulations (DSUR and PBRER)

If your Admin has enabled <a href="/en/lr/01381/">DSUR and PBRER Investigational Product Causality</a>, 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:

1. The _Study Product_ is blinded
2. The _Study Product Role_ is:
   1. _Investigational_
   2. _Active Comparator_
   3. _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.