Non-company drug causality assessment for clinical trial cases

Summary

Causality assessment for non-study non-company products in study cases.

Description

For clinical study cases, some agencies require the E2B reports to have a causality assessment for all suspect products including non-company products that are not part of the study configuration. Suspect non-company products can be a WHO Drug Product, J Drug, or Non-Company product manually added in the case form. Argus is enhanced to support capturing the causality assessment for non-company and non-study products.

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

Case form update in study cases

• You can capture causality data for all non-company non-study drugs in the Events > Event Assessment tab and in the Medical Review > Event Assessment tab. The non-company study drugs are displayed in the Event Assessment screen, as per the existing functionality to capture causality for both WHO drug and J drug.
• License and datasheet details appear blank for the non-company non-study drugs.
• You can capture data in the Events > Product-Event Details tab for the non-company products (study/non-study).
• The case level causality is computed based on the study products only irrespective of the company or non-company product.

Note:

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

Console updates

• A new check box Transmit Non-Company product Causality for study cases is added to the Argus Console > Code Lists > Argus > Reporting Destination > EDI tab.
• The marking of this checkbox determines if the causality assessment and latency data captured for the non-company non-study product is required to be transmitted to the agency.
• This checkbox does not affect the import functionality, i.e. the causality assessment data is imported to the case irrespective of this parameter setting.
• Case-level causality parameters in the expedited reporting rules do not consider causality data entered for non-company non-study drugs.

Reporting updates

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

Update consideration

• In the study cases that were created prior to upgrade, any 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 study cases agency level checkbox is unchecked by default for the existing agencies configured in the system prior to upgrade.

For more details refer to the following mapping documents:

• ArgusInterchange841_E2B (R2) 2.1 Export Mappings.xlsx
• ArgusInterchange841_E2B (R2) 2.2 Export Mappings.xlsx
• ArgusInterchange841_E2B (R2) Import Mappings.xlsx
• ArgusInterchange841_E2B (R3) Export Mappings.xlsx
• ArgusInterchange841_PMDA E2B (R3) Export Import Mappings.xlsx
• ArgusInterchange841_E2B (R3) Import Mappings.xlsx