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.

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.
  • 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 selects the primary Case Product and primary Case Assessment by default.

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

Most Conservative Assessment Criteria

The following table outlines how the system ranks Case Assessments using the above data, from most to least conservative:

Summary Seriousness Expectedness Relatedness
Fatal/LT
SUSAR
  • Fatal,
    or
  • Life Threatening
Unexpected Related
SUSAR Serious Unexpected Related
SESAR Serious Expected Related
NSUR Non-Serious Unexpected Related
NSER Non-Serious Expected Related
SU Serious Unexpected Unrelated
SE Serious Expected Unrelated
NSU Non-Serious Unexpected Unrelated
NSE Non-Serious Expected Unrelated

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.

Update Rule Set Product Selection to Use Most Conservative

  1. In the Admin area, go to Business Admin > 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
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