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 theMedical 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. - You can capture causality data for all non-company
non-study drugs in the
- 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.
- A new check box Transmit Non-Company product
Causality for study cases is added to the
- 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
Parent topic: Enhancements to Oracle Argus Safety