Learn about special considerations when reporting to the PMDA.
About Reporting to the PMDA
Vault Safety supports reporting to the PMDA in general and special scenarios, such as the following:
- One Last Time Reporting for Japan
- Validation against ICH and PMDA reporting rules and preventing the export of unsupported UCUM codes to PMDA E2B(R3) reports
- Support for Safety Measure and Research Reports
- Support for foreign clinical trial reporting, such as TIKEN scenarios and single or multiple Clinical Compound Number reporting in the J2.12 and J2.13 data elements of PMDA E2B(R3) reports
- Cross reporting for cross-agency Investigational to Investigational scenarios
- Blinded Study Product reporting
For information on generating PMDA E2B(R3) reports, see E2B Generation Data Mapping: PMDA E2B(R3).
One Last Time Reporting for Japan (PMDA)
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 Safety supports One Last Time Reporting for PMDA Localized Cases. For general information on this topic, see One Last Time Reporting.
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:
- The Rule Engine calculates the Due in Days and Due Date fields on the Localized Case Assessment (LCA) record.
- 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.
- When run, the Generate Local Reporting Details action evaluates OLT reporting requirements based on the details in the following sections.
Prerequisites
To use this feature, your Admin must enable Japan One Last Time Reporting in your Vault.
Submission Generation and Linking for PMDA Localized Cases
After creating the Local Reporting Detail (LRD) records, the Generate Local Reporting Details action ensures that each LRD record has an associated Submission record as follows.
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 Submission records, Vault creates a new Submission record with the Rule Engine Created field set to True and linked to the LRD record.
Note: An unused Submission is one that has its Rule Engine Created field set to True but is not linked to an LRD record.
If an LRD is for the Primary CPR and the Primary CPR has the Due Date field populated, Vault does the following:
- Sets the Submission record’s Due in Days and Due Date based on the Due in Days and Due Date fields on the LRD’s Primary CPR
- Moves the PMDA Submission record 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 specified in the Due in Days field below. |
| Due in Days | The Due In Days for Local OLT Submissions from the One Last Time Reporting for Japan ICSR setting if it is enabled and a value is specified. 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 | Set to No |
| One Last Time | Set to True |
| Rule Engine Created | Set to True |
| Reason | Set to Follow-Up |
| Organization | Same as previous |
Note: LRDs without a DCI are not considered for OLT reporting.
See Enable Japan One Last Time Reporting for more information about the One Last Time Reporting for Japan ICSR setting.
Delete Unused PMDA Submissions
If the Logically Delete Non-Submittable Transmissions on Subsequent Evaluations ICSR setting is enabled 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
Note: To make it easier to see which Submission records Vault has moved to the Deleted state, we recommend enabling the Logically Delete Non-Submittable Transmissions on Subsequent Evaluations feature in your Vault.
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
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 PMDA: Blinded Study Product Reporting.
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”
Note: If your Admin has enabled the Isolate Blinded Clinical Trial Information feature in your Vault, when Case Products have been unblinded, the reporting rule engine evaluates the unblinded product.
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 Set Up the Localized Business Admin Library for Japan.
Prevent Export of Unsupported UCUM Codes
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 Enable PMDA E2B(R3): Prevent Export of Unsupported UCUM Codes.
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 {DF}, 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 {DF} to the associated data element of the report.
This feature impacts the following PMDA E2B(R3) 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 Case and Submission Validation.
Aggregate Reports
Vault Safety provides Pharmaceuticals and Medical Devices Agency (PMDA) Post-Market report authoring and table generation capabilities. The Vault Safety PMDA Post-Market report adheres to the PMDA Guide to Electronic Reporting of Adverse Drug Reactions and Infectious Diseases. For more information, see Create PMDA Post-Market Aggregate Reports.