Non-company product causality assessment for non-study cases

Summary

Causality assessment for suspect non-company products in non-study cases (Enhancement 35522146)

Description

Oracle Argus is enhanced to support capturing the causality assessment for non-company and non-study products for all case types (previously supported for study cases only). Suspect non-company products can be a WHO drug product, J drug, or non-company product manually added in the case form.

Causality data is sent to agencies based on the configuration option provided in the Reporting Destination > Report tab.

Case form updates in all cases

• You can capture causality data for all suspect non-company products in the Events > Event Assessment tab and in the Medical Review > Event Assessment tab.
• For the suspect non-company products, license and datasheet details appear blank.
• You can capture data for the suspect non-company products (study or non-study) in the Events > Product-Event Details tab.
• The case level causality is not impacted by suspect non-company product assessments.

Note:

Listedness field is not available for the suspect non-company non-study drugs.

Console updates

• A new check box Transmit Non-Company product Causality for non-study cases is added to the Argus Console > Code Lists > Argus > Reporting Destination > Report tab.
• If this check box is checked, then the causality assessment and latency data captured for the suspect non-company product for non-study cases is transmitted to the agency.
• This check box does not affect the import functionality, that is, the causality assessment data is imported to the case irrespective of this parameter settings.
• Case-level causality parameters in the expedited reporting rules does not consider causality data entered for the suspect non-company products.

Reporting updates

• All E2B(R2) and E2B(R3) report mappings are enhanced to transmit the causality and latency data for the suspect non-company products based on the Transmit Non-Company product Causality for non-study cases switch at the agency level.
• Conformance rules for causality elements in the E2B(R3) report are revised to consider the Transmit Non-Company product Causality for non-study cases.
• Import mapping logic for all profiles is enhanced to consider the causality for suspect non-company products.
• There is no impact on the periodic reports due to causality data entered in suspect non-company products.

Update considerations

• In non-study cases that were created prior to upgrade, any suspect non-study, non-company product added will appear in the Event Assessment screen with blank causality assessment and must be updated manually.
• The new Transmit Non-Company product Causality for non-study cases agency-level check box is unchecked by default for the existing agencies configured in the system prior to upgrade.

For more details refer to the following mapping documents:

• ArgusInterchange843_E2B (R2) 2.1 Export Mappings.xlsx
• ArgusInterchange843_E2B (R2) 2.2 Export Mappings.xlsx
• ArgusInterchange843_E2B (R2) Import Mappings.xlsx
• ArgusInterchange843_E2B (R3) Export Mappings.xlsx
• ArgusInterchange843_PMDA E2B (R3) Export Import Mappings.xlsx
• ArgusInterchange843_E2B (R3) Import Mappings.xlsx