# Report to the PMDA

Safety supports reporting to the PMDA in general and special scenarios, such as the following:

* [One Last Time Reporting for Japan][1]
* Validation against ICH and PMDA <a href="/en/lr/01252/#pmda">reporting rules</a> and [preventing the export of unsupported UCUM codes to PMDA E2B(R3) reports][2]
* Support for <a href="/en/lr/696904/">Safety Measure and Research Reports</a>
* Support for foreign clinical trial reporting, such as <a href="/en/lr/872016/#tiken">TIKEN scenarios</a> and <a href="/en/lr/696910/#inv-reg-gen-rpt">single or multiple Clinical Compound Number</a> reporting in the <a href="/en/lr/700008/#j-section">J2.12 and J2.13 data elements</a> of PMDA E2B(R3) reports
* Cross reporting for <a href="/en/lr/01247/#inv-to-inv">cross-agency Investigational to Investigational</a> scenarios
* Generating multiple _Submissions_ for a single _Case_ with <a href="/en/lr/696910/#lrd-mah">multiple Marketing Authorization Holders (MAHs)</a>
* [Blinded Study Product reporting][3]
* <a href="/en/lr/826501/#destination-docs">Destination-specific document inclusion</a>

For information on configuring all available capabilities on this page, see <a href="/en/lr/693942/#prerequisites">PMDA Overview and Profile Setup</a>. For information on generating PMDA reports, see <a href="/en/lr/700008/">E2B Generation Data Mapping: PMDA E2B(R3)</a> and <a href="/en/lr/827489/">PMDA MHLW Paper Form Generation Data Mapping</a>.

## One Last Time Reporting for Japan (PMDA) {#japan-olt}

For a global _Case_, there is only one _Submission_ per _Case_. However, _Localized Cases_ for the Pharmaceuticals and Medical Devices Agency (PMDA) can have multiple _Submissions_. Vault supports <a href="/en/lr/01248/">One Last Time reporting</a> for PMDA _Localized Cases_.

Vault uses the **Destination Case ID** field at the Local Reporting Details level to determine if One Last Time Reporting is required for each PMDA Submission of a PMDA Localized Case, as follows:

1. The Rule Engine calculates the **Due in Days** and **Due Date** fields on the **Localized Case Assessment** (LCA) record.
2. Vault then sets the **Due in Days** and **Due Date** fields on the associated Case Product Registrations (CPR) with the most conservative LCA Due in Days.
3. When run, the **Generate Local Reporting Details** action evaluates OLT reporting requirements based on the details in the following sections.

### Submission Generation and Linking for PMDA Localized Cases {#pmda-localized-case-submission-generation}

After creating the _Local Reporting Detail (LRD)_ records, running the _Generate Local Reporting Details_ action ensures that each LRD has an associated _Submission_. Vault generates _Submissions_ using the <a href="/en/lr/01202/#transmission-profile-selection">matching _Transmission Profile_</a> based on the _Product Registration_ in each LRD.

#### Verify Each LRD has a Submission Record

Vault verifies that each reportable LRD is linked to a PMDA _Submission_ (ignoring any that are in the _Inactive_ state). If an LRD has no PMDA _Submission_ linked to it, Vault links it to an unused _Submission_, if one exists. If there are no unused _Submissions_, Vault creates a new _Submission_ with the _Rule Engine Created_ field set to _True_ and linked to the LRD.

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      <p><strong>Note</strong>: Vault considers a <em>Submission</em> unused if its <em>Rule Engine Created</em> field value is <em>True</em> but it is not linked to a <em>Local Reporting Detail (LRD)</em> record.</p>
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If an LRD is for the primary CPR and the primary CPR has a _Due Date_, Vault:

* Sets the _Due in Days_ and _Due Date_ on the _Submission_ based on the _Due in Days_ and _Due Date_ of the LRD's primary CPR
* Populates a _Reason_ on the _Submission_ based on whether the LRD includes a _Destination Case ID_ value:
  * If blank, Vault populates `Initial`
  * If populated, Vault populates `Follow-Up`
* Moves the PMDA _Submission_ to the _Ready_ state unless the _Submission_ was already sent and is in one of the following states: _Completed_, _Sent_, _E2B ACK Accepted_, _E2B ACK Rejected_, _E2B ACK Warning_, _MDN Failure_, _MDN Received_, _Sending ICSR_, _Sending Attachments_, or _Withdrawn_
* Generates the XML and runs _Submission_-level validation

### Evaluate One Last Time Reporting Requirements

Vault then evaluates whether the Case has a One Last Time (OLT) reporting obligation as follows:

For each non-reportable LRD with a Destination Case ID (DCI), Vault finds the most recent Submission which is in one of the states designated by the **One Last Time Reporting for Japan** ICSR setting and with the same DCI (referred to in the table below as "previous"). If this Submission is not an OLT Submission, Vault creates an OLT Submission with the following information:

| Submission Field |Setting
|--- |---
|_Transmission Profile_| Same as previous
|_Due Date_|The date setting on the localization's _Localized Due Date Calculation_ plus the _Due In Days_ amount in the _Due in Days_ field.
|_Due in Days_|The _Due In Days for Local OLT Submissions_ from the _One Last Time Reporting for Japan_ ICSR setting if enabled and populated. Otherwise, Vault uses the same _Due In Days_ as the previous PMDA _Submission_.
|_Local Reporting Detail_|The current LRD
|_Localized Case_|The _Localized Case_ of the current LRD
|_Local Expedited_|_No_
|_One Last Time_|_True_
|_Rule Engine Created_|_True_
|_Reason_|_Follow-Up_
|_Organization_|Same as previous

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      <p><strong>Note</strong>: LRDs without a DCI are not considered for OLT reporting.</p>
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#### Delete Unused PMDA Submissions

If your Admin has enabled the <a href="/en/lr/740208/#logically-delete">_Logically Delete Non-Submittable Transmissions on Subsequent Evaluations_</a> setting in your Vault, Vault moves any PMDA _Submission_ that matches either of the following criteria to the state associated with the _Deleted_ state type:

* The _Submission_ is not linked to an LRD
* The _Submission_ is not an OLT and its linked LRD does not have a primary CPR

#### Subsequently Reportable OLT Cases

If a Case with a One Last Time LRD and associated PMDA Submission is subsequently updated with new information and becomes reportable again, Vault re-uses the OLT PMDA Submission with the new reportable information as long as the PMDA Submission has not yet been sent.

## Blinded Study Product Reporting {#blinded-study-prod-reporting}

When reporting Clinical Trial _Study Cases_ with blinded _Study Products_ to the PMDA, you can identify the primary blinded investigational product. Vault uses this product to evaluate reporting rules and for E2B export for _Substances_. To use this feature, your Admin must enable <a href="/en/lr/726939/">PMDA: Blinded Study Product Reporting</a>.

When evaluating the general and cross reportability of blinded _Study Case Products_ to the PMDA, the reporting rules engine uses the following priority to evaluate blinded _Case Products_ with _Study Product Placeholder_ records:

* 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"

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      <p><strong>Note</strong>: If your Admin has enabled the <a href="/en/lr/691317/">Isolate Blinded Clinical Trial Information</a> feature in your Vault, when <em>Case Products</em> have been unblinded, the reporting rule engine evaluates the unblinded product.</p>
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Vault evaluates expectedness using the _Datasheet_ for the _Product_ that is substituted for the blinded _Study Product_.

For any blinded _Study Product_ on the _Case_ with a PMDA-reportable _Product Registration_, Vault exports the earliest created _Substance_ information from the primary blinded investigational product to the _G.k.2.3.r.1 Substance / Specified Substance Name_ data element of PMDA E2B(R3) reports.

On Localized Cases for Japan, when _Case Product Registrations_ are generated automatically by Vault or through the _Retrieve Reportable Case Product Registrations_ action, Vault maps information from the primary blinded investigational product and generates any general and cross reportable investigational registrations for each blinded _Study Product_.

For details on specifying the primary blinded investigational product on a _Study Product Placeholder_ record, see <a href="/en/lr/01194/#primary-inv-prod">Set Up the Localized Business Admin Library for Japan</a>.

## Prevent Export of Unsupported UCUM Codes {#prevent-ucum-export}

Your Admin can configure Transmission generation in your Vault to prevent the export of Unified Code for Units of Measure (UCUM) that are not supported by the PMDA. Beyond excluding unsupported units of measurement from PMDA E2B(R3) reports, Vault can replace such units with another value. This reduces instances of Submissions being rejected for unsupported codes and the need to send Cases back to Global Case Processors for correction.

For more information, see <a href="/en/lr/714862/">Enable PMDA E2B(R3): Prevent Export of Unsupported UCUM Codes</a>.

During Transmission generation, Vault validates the units of measurement in the following object fields:

* **Case Product Substance** > **Strength (Unit)**
* **Case Product Dosage**  > **Dose (Unit)**
* **Case Product**  > **Cumulative Dose (unit)**

If any unsupported UCUM codes are excluded or replaced with <code>{DF}</code>, Vault generates a **Validation Result** record listing all of the changes. The record includes the **Validation Criteria** Vault evaluated each excluded or replaced unit of measurement against, conformance guidance, and details about the affected data elements.

When unsupported units of measurement are set to be excluded only, the associated number value is also excluded. For example, when Vault excludes a **Strength (Unit)** value from a **Product Substance**, it also excludes the related **Strength (Number)** value on the PMDA E2B(R3) report.

When unsupported units of measurement are set to be replaced, Vault exports <code>{DF}</code> to the associated data element of the report.

This feature impacts the following <a href="/en/lr/700008/">PMDA E2B(R3)</a> data elements:

* **G.k.2.3.r.3a Strength (number)** and **G.k.2.3.r.3b Strength (unit)**
* **G.k.4.r.1a Dose (number)** and **G.k.4.r.1b Dose (unit)**
* **G.k.5a Cumulative Dose to First Reaction (number)** and **G.k.5b Cumulative Dose to First Reaction (unit)**

To learn more about viewing validation results, see <a href="/en/lr/01226/#view-validation-results">Case & Submission Validation</a>.

## Aggregate Reports

Vault provides Pharmaceuticals and Medical Devices Agency (PMDA) Post-Market report authoring and table generation capabilities. The Safety PMDA Post-Market report adheres to the PMDA Guide to Electronic Reporting of Adverse Drug Reactions and Infectious Diseases. For more information, see <a href="/en/lr/674650/">Create PMDA Post-Market Aggregate Reports</a>.

[1]: #japan-olt
[2]: #prevent-ucum-export
[3]: #blinded-study-prod-reporting