About Local Fields

A field is identified as a Local field to one or more countries based on a new attribute in the CMN_FIELDS table. The local fields for only Japan are supported in this release.

Customers can configure any field in the Case Form > General, Patient, Products, Events tabs, and in the Analysis > PMDA tab as a Local field for Japan through back-end updates to the CMN_FIELDS table.

The Enterprise copy configuration action will copy these updates as per existing functionality.

If a customer configures a field that could update global value as a local field, it is expected that the customers maintain the integrity of the global data by business SOPs or custom software processes.

All the fields in a case that is not a Local PRPT case are simply treated as global fields.

All Argus J users are considered as having access to edit the Japan local fields.

All Japanese text fields, including J User-Defined fields are considered as Local fields for Japan.

• All Japanese text fields are the fields that currently has separate _J columns.
• All fields from PMDA tab, PMDA Device Information section.

Oracle Argus Safety allows selection of secondary LLT (stored in LLT_J or LLT_CODE_J field) or Synonym (SYN_CODE_J) encoding using MedDRA J browser that does not change the base MedDRA hierarchy of English.

The Event Assessment > Listedness field in the tab for the licenses of the local country corresponding to the local user is considered as local field. However, this field is available for editing for the user only when the local user has listedness privilege for that local country assigned to them via the User Group > Listedness Determination - Countries access and the datasheet associated with that local country license is configured with Global /No Local Assessment Required checkbox as unchecked.

The Events tab > Infection and Event Exclusion checkbox are also considered as local field for Japan.

Any field where an update to a global field can occur is NOT considered as Local field.

All numeric fields, date fields, drop-down fields which share same data value for English and Japan sides are not considered as Local fields.

However, there are exceptions to this rule where some fields that contain global values are available for update to local users and in such a scenario, it is expected that the global value should be protected by customer's business SOPs.

Case Classification is such a field that can cause update to global value and it is available as a Local field in the application out-of-the-box.

Study section under General tab requires special handling by the application during local editing. Study Name, Study Description, Protocol Number, Clinical Compound Number and Center Name are local fields.

When the study is a configured study, all these fields are disabled for local editing except Center Name (J). Center Name (J) is available as an editable local field.

The Product Information section in Products tab requires special handling by the application during local editing. J Drug Code type and the corresponding J Drug Code/OTC Drug Code/Temporary Code (i.e., DRUG_CODE_TYPE_J, DRUG_CODE_J,), J Generic Name and J Product Name fields are local fields.

Any field that is already editable after case lock will remain editable even after local lock.

An auto-narrative generation performed during Japan Local data entry (after global lock) only updates the J field value and does not update the English or any other language field value.