Validation Rules

Validation Rules for all profiles can be viewed from Oracle Argus Safety Console > System Configuration > Interchange Mapping > Manage Profile.

E2B Generation validation rules are executed on the generated ICSR report data.

The validation rules that are applicable to individual element is governed by configuration in the Conformance Rules tab for that element for the respective profile.

Validation Rule the elements is categorized amongst the following categories:

• Basic Data Validation: This category covers all the applicable validation based on the Length of the field.

  Length - This validation check validates if the data type length of output is within with the configured Data length or not. If the data length is exceeding the configured length then validation error is listed in the validation report.

• Allowed Values Data Check: The element for which the Allowed Value Check Required checkbox is checked is validated against the allowed values codes associated with them using Allowed Values Configuration Dialog for the respective profile.
• Mandatory Along with (Together): Elements for which the Mandatory along with element is specified, validation rule validates for such elements in the generated ICSR the element itself and the configured Dependent element co-exist or none of them exists in the report.
• Validation Category Based: The element is validated as per the value configured for that element in the Validation Category drop-down list in the Conformance rule tab.

  The elements for which there exists a SQL based validation for which Primary Validation checkbox is checked in the Additional Validation Configuration Dialog, the framework based validation is not executed for them; rather the configured SQL based validations is executed for them.

  These validations are categorized in two sub categories, one for the ICSR reports for EMA the profile, and the other ICSR Report for PMDA profile

  • EMA

  The validation for the PMDA report is fired at each reporting category level:

  Mandatory: The element which is configured as Mandatory should be present in the ICSR Report; if it is not present in the report output then application displays the validation failure in the validation report.

  Conditional Mandatory: The element which is marked as Conditional Mandatory is present based on certain condition, hence it is expected that user will configure a Validation for it in the Additional Validation Dialog. There is no framework based validation for the elements configured with this validation type in Conformance rule tab.

  Optional: The element which is marked as optional may or may not be present in the report, but still there could be a possibility that there might exist a validation under the Additional Validation Dialog and if any of the configured validation is failed it will be listed in the validation report.

  Other Fatal: There is no framework based validation for the elements configured as other fatal validation type in Conformance rule tab.

  • PMDA E2B

    Mandatory: The element which is configured as Mandatory should be present in the ICSR Report; if it is not present in the report output then application displays the validation failure in the validation report.

    Mandatory for Completion: The element which is marked as Mandatory for completion should be present in the ICSR Report if J2.7.1 (MHLWADMICSRCOMPLETECLASS) = completed for that report; if it is not present then application displays the validation failure in the validation report.

    Conditional Mandatory and Conditional Mandatory for Completion: The element which is marked as Conditional Mandatory or Conditional Mandatory for Completion is present in the report based on certain condition, hence it is expected that user will configure a Validation for it in the Additional Validation Dialog. There is no framework based validation for the elements configured with these validation types in Conformance rule tab.

    Do not Enter: The element which is marked as Do not enter are not present in the report, and if they are present than application lists the validation failure in the validation report (Argus report generation logic removes the elements that are marked as Do not enter at the time on generation itself).

    Optional: The element which is marked as optional may or may not be present in the report, but still there could be a possibility that there might exist a validation under the Additional Validation Dialog and if any of the configured validation fails, it is listed in the validation report.

    Other Fatal: There is no framework based validation for the elements configured as other fatal validation type in Conformance rule tab.

• Additional Validations: The Additional SQL based validations associated with elements in the respective ICSR profile (element level for E2B other than PMDA and Reporting category level for PMDA E2B), the validation is fire based on the SQL logic specified under the Validation SQL.

Validations for MIR:

• When you click the Draft button for the MIR Report, the validations are performed based on conformance rulesfor EC, and lists failed validations in the MIR Validation Report.
• The MIR Validation Report can be viewed as a PDF report.
• If the case data has the necessary data to meet the conformance rules for EC, a draft MIR XML (default) or PDF is generated in a separate window. You can MIR PDF from the View format.
• When the MIR report is generated by the AG Services, validation check is performed and the validation errors are logged in the log file.