Message Type and Clinical Reference Type codelists enhancements

Summary

Codelist updates for Health Canada and EMA (Enhancement 31456510)

Description

Message Type codelist

The following message types used for Health Canada Agency (TPMO) have been added to the Message Type standard codelist:

• sapicsr: Expedite ICSRs as per the guidance for the Special Access Programme.
• camricsr: Expedite ICSRs as per the guidance for Canada's Access to Medicines Regime.
• cticsr: Expedite ICSRs from interventional clinical trials.

Clinical Reference Type codelist

The Clinical Reference Type codelist has been updated with the EU Trial Number value required to report studies that are registered under the EU Clinical Trial Regulation.

For more information, refer to Argus_Safety8.4_CaseForm_Console_Updates_Summary.xls.