Enable Japan Domestic Cases

With the 24R2 release, you can calculate due dates for Localized Case Assessments from Japan domestic Cases. The Calculate Due Dates on LCA action provides users the flexibility to calculate due dates without leaving the domestic Case page or generating Transmissions. Previously, calculating due dates for Localized Case Assessments was available only on Japan Localized Cases.

After configuring this feature, learn about assessments in Complete Intake and Process Cases for the PMDA.

Prerequisites

Before configuring this feature, ensure you have enabled the following features:

In addition, you must configure the Localization record for Japan to generate Localized Case Assessments and Expectedness for each Case Product Registration and Case Adverse Event pair. For more information on assessment generation options, see Set Up the Localized Business Admin Library for Japan.

26R3 Update: PMDA Domestic Case Processing Efficiencies

With the 26R3 release, Safety supports PMDA domestic Case processing in a unified view. By integrating regional and global data on the Case object, Case Processors no longer need to switch between the domestic Case and Localized Case to review and manage all of the available data. With this feature, PMDA domestic Cases now include regionally relevant object records and fields, such as Case Product Registrations, Localized Case Assessments, Localized Device Codes, and Outcome (Other). In addition, Safety now also supports running regulatory actions, such as reportability calculations and document generation, directly on PMDA domestic Cases. By streamlining this workflow, Japan Case Processors can efficiently move from initial data entry to submission. To use the latest functionality, configure your Vault.

Configure the Calculate Due Dates on LCA Action

To add the Calculate Due Dates on LCA user action to the Case object:

  1. Navigate to Admin > Configuration > Objects > Case > Actions.
  2. Select Create.
  3. In the Select Action field, select Calculate Due Dates on LCA, and then select Continue.
  4. On the Create Action page, select the Available in All Lifecycle States checkbox.
  5. On the Atomic Action Security Defaults dialog, adjust the default action settings for each lifecycle state if needed, and then select Save.

Result

The Calculate Due Dates on LCA user action is available in all states of the Case Lifecycle. Use the following section to configure the action so it’s available only for Cases with the Localization field set to Japanese (Japan). This action should not be available for Cases with other Localizations.

Add a User Action Rule to States on the Case Lifecycle

To make the Calculate Due Dates on LCA user action available only on domestic Cases for Japan:

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Lifecycle.
  2. In the States section, select the state you want to edit.
  3. In the User Actions section, select Edit.
  4. Select Create Rule, and then populate the fields as follows:
    1. Select Perform with conditions.
    2. Set the following condition: If Localization > equals > Japanese (Japan).
    3. In the Allow the following actions picklist, select Calculate Due Dates on LCA.
    4. In the Action Label field, enter “Calculate Due Dates on LCA”.
  5. Select Save.

(26R3) Configure PMDA Domestic Case Processing Efficiencies

To configure your Vault for this feature, update object layouts and configure user actions.

Update Object Layouts

To ensure your Vault includes all the latest sections, fields, and layout rules for this feature, we recommend copying standard layouts and customizing them according to your business needs. This feature updates the standard layout for the following objects:

  • Case
  • Case Product
    • Company Device object type layout
    • Company Product object type layout
  • Case Adverse Event

Alternatively, you can update your existing layouts as described in the following sections.

Update the Case Layout

To update the Case object layout:

  1. Insert a page, and change the default Page label to Regional.
  2. On the new Regional page, insert the Case Product Registration related object section.
  3. Create a layout rule with the following configuration:
    • Label: Enter PMDA Only Regional.
    • Description: Enter Hides the Regional section on non-Japan domestic Cases.
    • IF this Layout Rule Expression is TRUE: Enter localization__vr.name__v != 'Japanese (Japan)'.
    • Apply the following display effects: Select Hide > Pages > Regional.

Update the Case Product Layout

On the Case Product object, update the Company Device and Company Product object layouts:

  1. After the Device Codes section, add the Localized Case Product Device Code related object section.
  2. Edit the default columns to include:
    • Name
    • Local Code
    • Local Term
    • Possible Patient Health Damage
  3. Create a layout rule with the following configuration:
    • Label: Enter PMDA Only Local Device Codes.
    • Description: Enter Hides the Localized Case Product Device Code section on non-Japan domestic Cases.
    • IF this Layout Rule Expression is TRUE: Enter localization__vr.name__v != 'Japanese (Japan)'.
    • Apply the following display effects: Select Hide > Section > Localized Case Product Device Codes.

Update the Case Adverse Event Layout

To update the Case Adverse Event object layout:

  1. Insert the Adverse Event Regional control section with the Slider (app-control) icon.
  2. Create a layout rule with the following configuration:
    • Label: Enter PMDA Adverse Event Regional.
    • Description: Enter Hides the Adverse Event Regional section on non-Japan domestic Cases.
    • IF this Layout Rule Expression is TRUE: Enter localization__vr.name__v != 'Japanese (Japan)'.
    • Apply the following display effects: Select Hide > Section > Adverse Event Regional.

Configure User Actions

Configure user actions on Cases with a Localization value of Japanese (Japan) as follows:

  1. Assign the following actions to the Case object:
    • Retrieve Case Product Registrations
    • Calculate Japan Reportability
    • Generate Localized Case Documents
  2. Add each action as a user action to the applicable states of the Case object lifecycle with the following rule:
    • Condition Type: Select All conditions are met.
    • If: Select Localization (select the option under the CASE heading) > equals > Japanese (Japan).
  3. Based on your business process, configure Atomic Security for each user action and lifecycle state.