Pre-upgrade preparations

To ensure that the desired RoA and Formulations are available for case processing, organizations need to prepare with the following activities.

We advise organizations to review the Code list terms present in Argus for RoA and DF against Standard Term List and identify the terms that need to be available for data entry for your organization. This will ensure that the desired terms are available for data entry. The number of entries available for data entry during case processing are limited.

You can use the Case Form Console summary document provided as part of 8.2.3.1 eTRM to identify factory data and associated mapping to EDQM standard terms: ArgusSafety8.2.3.1_CaseForm_Console_Updates_Summary.xls.

Routes of Administration and Formulation Code List

Identify the terms that need to be available for data entry for your organization.

Note:

New terms added as part of the release are not available for data entry by default.

You can minimize the list further, if there are no reporting obligations to E2B(R2)/eVAERS/eMDR/PMDA, by marking the non-standard terms as Display=unchecked.