Reporting Rules Product Selection

Learn how Vault determines the most reportable Case Product and Case Assessments for reporting rule evaluations.

Rule Parameters Requiring Case Product and Case Assessment

Vault evaluates the following rule set parameters using a Case Product and Case Assessment:

• Serious
• Fatal
• Life Threatening
• Expected
• Assessment Criteria
• AE in Jurisdiction
• Assessment Source
• Related

Vault uses a set of criteria to determine the “Most Reportable” Case Product and Case Assessment to use for these parameters, as described in the following section.

Most Reportable Case Product and Case Assessment

Vault evaluates the Most Reportable Case Product and Case Assessment by performing the following steps:

1. Find the list of eligible Case Products based on the Case Type.
   For both general and cross reporting, if your Admin has enabled Extend Definition of Suspect to Drug Not Administered, Case Products with the Drug Role of Drug Not Administered are included in the list of eligible Case Products. Otherwise, Case Products with only the Drug Roles of Suspect or Interacting are included.
2. Find and evaluate the Most Reportable Case Assessment.
3. Perform a tie breaker if required.

The logic used in each of these steps for General Reporting is different from that used for Cross Reporting, and is described in the following two (2) sections.

Most Reportable Product Selection for General Reporting

Step	Logic
1. Find Eligible Products based on Case Type	Depending on the Case type, Vault uses the following logic to determine which Case Products (and their associated Assessments) are considered eligible for the Most Reportable Product: Case Type Case Products considered as eligible for Most Reportable Product Clinical Trial Only Study Products within the specified Study Postmarket Study Spontaneous Case Only Products that are registered to the Jurisdiction of the Agency being evaluated Study with Unspecified Products The list of eligible products are further limited if any of the following rule parameters are defined: Rule Parameter Case Products considered as eligible for Most Reportable Product Product Only those Products that match the specified Product (or list of Products) Study Only those Products that match the Study Product within the specified Study Product Registration Type Only those that have the same Product Registration Type for the Reporting Destination
2. Find and Evaluate the Most Reportable Assessment	Of the remaining Case Products from the previous step, Vaults select the Case Product Assessments that satisfy the specified non-Case Data - Expression Rule Parameters. Then, of these Case Product Assessments, Vault selects those that satisfy any Case Data - Expression parameters. The following examples demonstrate the Case Product Assessment selection process: If the rule contains Serious = No, Vault considers only Non-Serious Assessments (if any) as eligible. If the rule contains contains Serious = No and a Case Data - Expression parameter with a Value of VS_LET(ca, eligible_case_assessments__v, ca.expectedness__vr=false), Vault considers only Non-Serious Unexpected Assessments as eligible. Note: If no Assessments match the Rule Parameters, the Rule fails.
3. Tie Breaker	If any eligible Assessments remain from the preceding steps, the Rule passes and the earliest created Assessment is selected as the Most Reportable Assessment. This Assessment's Product is selected as the Most Reportable Product. If there are any Custom Safety Reporting Rule SDK Parameters, these are run on any remaining Assessments. If the Custom Parameter passes, the evaluation is stopped (no further Assessments are considered) and the evaluated Assessment is selected as the Most Reportable Assessment.

Most Reportable Product Selection for Cross Reporting

Step	Logic
1. Find Eligible Products based on Case Type	Depending on the Case type, Vault uses the following logic to determine which Case Products (and their associated Assessments) are considered eligible for the Most Reportable Product: Cross Reporting Scenario Case Products and Assessments considered as eligible for Most Reportable Product X→I Only Products or Substances which are within the cross reportable Study X→M Only the Product or Substance which is being cross reported to The list of eligible products are further limited if any of the following rule parameters are defined: Rule Parameter Case Products considered as eligible for Most Reportable Product Product Only those Products that match the specified Product (or list of Products) Study Only those Products that match the Study Product within the specified Study Product Registration Type Only Products with the matching Product Registration type for the cross reportable destination (Agency)
2. Find and Evaluate the Most Reportable Assessment	The logic used here is the same as in step 2 for General Reporting above, with the addition that the Product and Study Parameters are substituted based on which cross reportable Product or Study is being used. See the Product and Study Reporting Rule Parameters for more information.
3. Tie Breaker	The logic used here is the same as in step 3 for General Reporting above.