Configure Reporting Rules Product Selection

You can configure whether the system uses the primary or most conservative Case Product and Case Assessment for reporting rule evaluations.

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Rule Parameter Evaluation Methods

Certain rule set parameters are evaluated using a Case Product and Case Assessment. You can customize how the system selects the Case Product and Case Assessment using the Product Selection field on the Safety Rule Sets.

Vault Safety supports the following methods for evaluating reporting rule set parameters:

The following parameters are evaluated differently depending on the evaluation method:

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

Note Other than the above listed parameters, all other rule set parameters are evaluated the same for both methods.

Primary Case Product and Case Assessment

By default, Vault Safety evaluates reporting rule parameters using the primary Case Product and Case Assessment.

The primary Case Product and Case Assessment are the records assigned a value of “1” in the Rank (rank__v) field. Typically, the primary Case Assessment links the primary Case Adverse Event with the primary Case Product.

The system uses this method unless configured otherwise. If the Product Selection field is not specified, the system uses the primary product evaluation method by default.

Most Conservative Case Product and Case Assessment

The most conservative product and assessment may be different when there are multiple reporting destinations and regions. Vault Safety supports the option of using the most conservative Case Product and Case Assessment per region to evaluate certain rule set parameters.

You must set the Product Selection field to Most Conservative Product to use this method. We recommend using this method.

Note For Partner Distribution Lists, see the considerations for using the Most Conservative Product evaluation method on the Manage Partner Distribution Lists page.

The reporting rule engine uses different logic for determining Case reportability depending on whether the Parameter Driven Assessment Selection feature is turned on. See Most Reportable Case Product and Case Assessment below for details.

Note We recommend enabling this feature in your Vault. To do so, contact Veeva Support.

If the Parameter Driven Assessment Selection feature is not turned on, the system evaluates the Most Conservative Case Product and Case Assessment as follows.

Most Conservative Product Criteria

The system finds the most conservative Case Product for a region using the following criteria:

  • Contains a Product Registration for a Country within the jurisdiction of the Agency being evaluated by the rule set.
  • Contains a Drug Role set to Suspect or Interacting.
  • Is associated with the most conservative Case Assessment for the region.

    If one or more Case Products for the region are not associated with a Case Assessment, the system queries all Case Products with Case Assessments to identify the most conservative product and assessment.

  • For cross reporting, if the Eligible Products Based on Cross Reporting feature is turned on, the system considers only Case Products that are being cross reported to, rather than all Case Products.

    Note To enable this feature, contact Veeva Support.

Note If multiple Case Products match the above criteria, the system uses the product with the highest value in the Rank field.

Note Device constituents cannot be considered the most conservative product.

Most Conservative Assessment Criteria

Using the above data, the system ranks Case Assessments depending on whether your Admin has enabled the Prioritize Seriousness for MCP (Most Conservative Product) feature.

Note We recommend enabling this feature in your Vault. To do so, contact Veeva Support.

Ranking with the Prioritize Seriousness for MCP feature not enabled:

Summary Seriousness Expectedness Relatedness Ranking
Fatal/LT
SUSAR
  • Fatal,
    or
  • Life Threatening1
 Unexpected Related 1 (Most Conservative)
SUSAR Serious Unexpected Related 2
SESAR Serious Expected Related 3
NSUR Non-Serious Unexpected Related 4
NSER Non-Serious Expected Related 5
SU Serious Unexpected Unrelated 6
SE Serious Expected Unrelated 7
NSU Non-Serious Unexpected Unrelated 8
NSE Non-Serious Expected Unrelated 9 (Least Conservative)
1. If a case contains both a Life Threatening SUSAR and a Fatal SUSAR, the tiebreaker for Most Conservative Assessment will be the Fatal SUSAR.

Ranking with the Prioritize Seriousness for MCP feature enabled:

Summary Seriousness Expectedness Relatedness Ranking
Fatal/LT
SUSAR
  • Fatal,
    or
  • Life Threatening1
 Unexpected Related 1 (Most Conservative)
SUSAR Serious Unexpected Related 2
SU Serious Unexpected Unrelated 3
SESAR Serious Expected Related 4
SE Serious Expected Unrelated 5
NSUR Non-Serious Unexpected Related 6
NSU Non-Serious Unexpected Unrelated 7
NSER Non-Serious Expected Related 8
NSE Non-Serious Expected Unrelated 9 (Least Conservative)
1. If a case contains both a Life Threatening SUSAR and a Fatal SUSAR, the tiebreaker for Most Conservative Assessment will be the Fatal SUSAR.

The system considers the most conservative Case Assessment for a region using the following data:

  • Seriousness: The Seriousness of the Case Adverse Event associated with the Case Assessment.
  • Expectedness: The Expectedness associated with the Case Assessment. Case Assessment Expectedness are automatically calculated using Datasheets.

    The system uses logic to evaluate the appropriate Expectedness records for this parameter. To see the detailed logic, click the button below:

  • Relatedness: The Causality Established field on Assessment Results under the Case Assessment. A product and event are considered Related when one or more Case Assessment Results have the Causality Established field set to Yes or Blank.

    Note For rules that use the Assessment Source parameter, such as FDA SUSAR reporting rules, to evaluate relatedness, the system only considers Case Assessment Results with a matching Source Type to find the most conservative Case Assessment.

Note Assessments for device constituents cannot be considered the most conservative assessment.

Most Reportable Case Product and Case Assessment

If your Admin has enabled the Parameter Driven Assessment Selection feature, the system evaluates the Most Reportable Case Product and Case Assessment by performing the following steps:

  1. Finds the list of eligible Case Products based on the Case Type
  2. Finds and evaluates the Most Reportable Case Assessment
  3. Tie breaker

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 sections.

Most Reportable Product Selection for General Reporting

Step Logic
1. Find Eligible Products based on Case Type Depending on the Case type, the system 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 Case Products remaining from the previous step, select only those Case Product Assessments that satisfy the specified Rule Parameters. For example, if the rule contains ‘Serious = No’, consider only Non-Serious Assessments (if any) 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, the system 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

If the Eligible Products Based on Cross Reporting feature is enabled, the following is selected:

  • Only Products or Substances which are within the cross reportable Study

If the Eligible Products Based on Cross Reporting feature is not enabled:

  • Any Study Product with a drug role of Suspect or Interacting
X→M

If the Eligible Products Based on Cross Reporting feature is enabled, the following is selected:

  • Only the Product or Substance which is being cross reported to

If the Eligible Products Based on Cross Reporting feature is not enabled, the following is selected:

  • Any non-external Case Product with a drug role of Suspect or Interacting
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.

Update Rule Set Product Selection to Use Most Conservative

  1. Go to Business Admin > Objects > Safety Rule Sets.
  2. Select a Safety Rule Set and then select the edit-icon icon.
  3. Next to Product Selection, select Most Conservative.
  4. Save the Rule Set.

Result

The system is updated to use the most conservative Case Product and Case Assessment when evaluating certain rule parameters for this Rule Set.

Cross Reporting
Manage Reporting Rule Versions
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