Sections in This Article
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 Reportable Case Product and Case Assessment
The system evaluates the Most Reportable Case Product and Case Assessment by performing the following steps:
- Finds the list of eligible Case Products based on the Case Type
- Finds and evaluates the Most Reportable Case Assessment
- 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 (2) 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:
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| 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:
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| 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
- Go to Business Admin > Objects > Safety Rule Sets.
- Select a Safety Rule Set and then select the Edit (
) icon. - Next to Product Selection, select Most Conservative.
- 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.
