Note: Although Vault supports the PMDA E2B(R3) data elements in section J2, these fields are not available on the Inbox Item during manual creation. You must enter the required data after promoting the Inbox Item to a Case.
### Calculate Japan Reportability {#calc-japan-reportability}
The _Calculate Japan Reportability_ action on Japan _Localized Cases_ generates _[Case Product Registration][10]_ records, evaluates their reporting obligations, and creates the associated _[Local Reporting Details][12]_ records and Submissions.
## Case Product Registration Section {#cpr-section}
The _Case Product Registration_ section captures Japan _Case Product Registrations_. For both domestic _Cases_ and _Localized Cases_, during _Case Product Registration_ record creation, details are mapped from the Japan _Product Registration_ when available. See the sections below for information on when Vault generates records for Domestic Cases and Localized Cases. For information on the available _Case Product Registration fields_, see PMDA Case Field Reference.
When a _Product_ includes PMDA registrations for [multiple Marketing Authorization Holders (MAHs)][16], Vault generates _Case Product Registrations_ for each MAH based on _Registration Holder/Applicant_ values on _Product Registrations_. Vault then maps the _Registration Holder/Applicant_ value to related _Local Reporting Details_ records.
When you [delete _Case Product Registrations_][15], Vault cascades deletions to associated localized records and clear references in related records.
### Domestic Case Product Registration Generation {#domestic-gen}
On domestic _Cases_ for Japan, when a PMDA _Product Registration_ is selected for the _Case Product_, Vault populates _Case Product Registrations_ and the associated _Case Assessments_. Vault generates _Case Product Registrations_ and _Case Assessments_ in the following scenarios:
* Upon _Case_ promotion if a PMDA _Product Registration_ exists on the _Inbox Item_
* Upon using the _Re-generate Domestic Case_ action
* Upon adding a _Case Product_ with a PMDA _Product Registration_ with an eligible _Drug Role_
* Upon changing the _Product Registration_ of an existing _Case Product_ with an eligible _Drug Role_ from a blank or non-PMDA _Product Registration_ to a PMDA _Product Registration_
* Upon changing the PMDA _Product Registration_ of an existing _Case Product_ with an eligible _Drug Role_ to a different PMDA _Product Registration_
* Upon using the _Evaluate Regulatory Conformance_ action
Vault deletes _Case Product Registrations_ and associated _Case Assessments_ upon changing the _Product Registration_ of an existing _Case Product_ with an eligible _Drug Role_ from a PMDA _Product Registration_ to either a non-PMDA _Product Registration_ or to blank. If your Admin has enabled Isolate Blinded Clinical Trial Information in your Vault, Vault deletes _Case Product Registrations_ in this scenario only when the _Blinding Type_ is not _Blinded_.
### Localized Case Product Registration Generation {#localized-gen}
Depending on your Admin's configuration, Vault may generate _Case Product Registrations_ upon _Localized Case_ creation. To manually generate _Case Product Registrations_, from the **All Actions** menu, select **Retrieve Reportable Case Product Registrations**. When you run this action, Vault:
* Deletes both Vault-generated and manually created _Case Product Registrations_
* Generates new _Case Product Registrations_ based on the latest _Case Product_ updates
* For _Products_ with _Product Registrations_ for multiple MAHs, Vault generates:
* _Case Product Registrations_ for all investigational registrations, regardless of the _Registration Holder/Applicant_
* One _Case Product Registration_ for the [applicable postmarketing registration][2] for each MAH, and one for the applicable postmarketing registration across all _Product Registrations_ with an unspecified _Registration Holder/Applicant_
* If your Admin has enabled _Device Constituent Case Assessments_, Vault creates _Case Product Registrations_ for:
* Standalone devices
* Each constituent device or drug of a combination product
* Clears the _Primary Case Product Registration_ field on _Local Reporting Details_
* For _Cases_ related to an unknown formulation _Product_, Vault generates _Localized Case Product Registrations_ for each _Product Registration_ within the _Product Family_ that is related to the unknown formulation _Product_
For blinded _Study Products_, Vault generates _Case Product Registrations_ using the following priority:
* The primary blinded investigational product identified on the _Study Product Placeholder_ record
* The earliest created _Study Product_ with a _Study Product Role_ of _Investigational_ that is associated with the _Study Product Placeholder_ record
* The earliest created _Study Arm Product_ with an associated _Study Product_ that has a _Study Product Role_ of _Investigational_
When populating reportable _Case Product Registrations_, Vault evaluates all reporting obligations in the following instances:
* [Marketing Registrations (General Reporting)][2]
* [Marketing Registrations (Cross Reporting)][4]
* [Investigational Registrations (General Reporting)][5]
* [Investigational Registrations (Cross Reporting)][6]
* A product reportable to the PMDA includes the same substance as a suspect or interacting _Case Product_ on the _Localized Case_ (see both Cross Reporting scenarios linked above)
* A blinded _Study Product_ is reportable to the PMDA
Vault considers existing _Case Product Registrations_ not reportable and removes them from domestic _Cases_ or _Localized Cases_ in the following instances:
* The _Drug Role_ of the associated _Case Product_ is no longer _Suspect_, _Interacting_, or _Drug Not Administered_.
* If your Admin has enabled Isolate Blinded Clinical Trial Information in your Vault, Vault deletes _Case Product Registrations_ in this scenario only when the _Blinding Type_ is not _Blinded_.
* The _Product_ or _Product Registration_ associated with the _Case Product_ or _Study Product_ was deleted, inactivated, or deprecated.
#### Marketing Registrations (General Reporting) {#mkt-reg-gen-rpt}
Vault generates one marketing _Case Product Registration_ when the Japanese _Registration Category_ is _Marketing_ and the following details from the _Localized Case Product_ match a _Case Product Registration_:
* _Dose Form_, _Strength Number_, and _Strength Unit_ \
If the above don't all match, Vault matches on _Dose Form_ alone.
* The PMDA _Product Registration_ is set up as the default registration
If there are multiple matches, Vault selects the PMDA _Product Registration_ with a matching _Dose Form_ and the earliest _Created Date_.
When the related _Product_ includes _Product Registrations_ for multiple _Registration Holder/Applicants_, Vault generates a postmarketing _Case Product Registration_ for each _Registration Holder/Applicant_. If that _Product_ also includes _Product Registrations_ with no _Registration Holder/Applicant_ value, Vault generates one postmarketing _Case Product Registration_ using the same selection criteria.
#### Marketing Registrations (Cross Reporting) {#mkt-reg-crs-rpt}
If Vault did not create a [marketing _Case Product Registration_ for general reporting][2], then Vault generates the following _Case Product Registrations_ for each _Case Product_ for cross reporting:
* One _Case Product Registration_ from the marketing _Product Registrations_ for the _Case Product_ using the same selection criteria as for Marketing Registrations (General Reporting).
* For the exact _Substance_-matched cross-reportable _Products_, a _Case Product Registration_ for one registration per exact matching cross-reportable _Product_ using the same selection criteria as for Marketing Registrations (General Reporting).
* If there are no exact _Substance_-matched cross-reportable _Products_, then for each partial _Substance_-matched cross-reportable _Product_, Vault generates a _Case Product Registration_ for one registration per partial matching cross-reportable _Product_ using the same selection criteria as for Marketing Registrations (General Reporting).
As with general reporting, during cross reporting Vault generates a postmarketing _Case Product Registration_ for each applicable MAH, based on _Registration Holder/Applicant_ values, including one across all postmarketing _Product Registrations_ with no _Registration Holder/Applicant_ value.
#### Investigational Registrations (General Reporting) {#inv-reg-gen-rpt}
The Japanese _Registration Category_ is _Investigational_.
If there are multiple matches, Vault adds them all to the _Localized Case_.
#### Investigational Registrations (Cross Reporting) {#inv-reg-crs-rpt}
For investigational registrations with the PMDA, Vault generates a _Case Product Registration_ for cross reporting if it is a _Product Registration_ for a _Product_ on the _Case_ or a _Product Registration_ for a cross-reportable _Product_ with exact matching _Substances_.
## Local Reporting Details Section {#lrd-section}
If your Admin has enabled the PMDA Local Reporting Details Generation and Submission Linking feature, you can select the **Generate Local Reporting Details** action in the **All Actions** menu on Japan domestic _Cases_ and _Localized Cases_. For all Japan _Case Product Registrations_ with _Due Date_ and _Due in Days_ values, Vault generates a _Local Reporting Details_ record for each of the primary postmarketing and investigational _Registration Types_, if they exist on the Case. When _Products_ include [multiple MAHs][16], Vault generates _Local Reporting Details_ and related records for each MAH. For information on the available _Local Reporting Details_ fields, see PMDA Case Field Reference.
Vault determines the primary _Case Product Registration_ using the following priority order:
1. The earliest _Due Date_ for each _Registration Type_.
2. If there are multiple registrations for a _Registration Type_ with the same _Due Date_, Vault evaluates the highest _Rank_. Additional evaluation depends on the _Registration Type_:
* **Postmarketing:** If there are multiple registrations with the same _Rank_, Vault evaluates the earliest _Created Date_.
* **Investigational:** If there are multiple registrations with the same _Rank_, Vault evaluates the _Case Product Registration_ linked to a _Study Product_ or _Product_ on the _Case_. If there are still multiple, Vault evaluates the earliest _Created Date_.
In addition to generating _Local Reporting Details_ records, the _Generate Local Reporting Details_ action generates records as follows:
* [_PMDA Reportable Products_][3]
* [_Case Comments_][1]
* _Submissions_
Vault considers _Case Product Registrations_ without _Due Date_ or _Due in Days_ values to be not reportable.
Note: If your Admin has configured Isolate Blinded Clinical Trial Information in your Vault, the following occurs when you run the Generate Local Reporting Details action. If a Case is unblinded and includes unblinded and blinded Case Product Registrations, Vault sets the unblinded Case Product Registration on the related Local Reporting Details record. In addition, Vault generates one PMDA Reportable Products record for each of the unblinded Case Product Registrations.
Note: If Local Reporting Details are system-generated, Vault assigns a Rank based on the Rank in the Case Product Registration section.