In addition to the general localized Business Admin library options, Vault supports configuring Products and Studies for the intake and processing of Cases for Japan and compliant reporting to the PMDA. This includes the following:
- Adding Japan-reportable Product Registrations and Substance Registrations for investigational and postmarketing products
- Configuring regionally required information such as Registration Type, Japan Drug Codes, and Clinical Compound Numbers
- Find the Registration Types in Business Admin > Objects > Controlled Vocabularies and filter to PMDA
- Specifying the primary blinded investigational Product for reporting blinded Products in blinded Study Arms
Prerequisites
To take full advantage of the Japan and PMDA functionality in Vault, you must review and enable PMDA-related features. To add Japan Product Registrations and Localized Substances, the Product must already exist.
Set Up the Japan Localization
You can configure Localizations to meet specific reporting needs and reduce manual effort when working on domestic Cases and Localized Cases. For the Japan Localization, you can configure the following behaviors:
- Auto-population of reportable Case Product Registrations to expedite data entry for the J2 data elements of PMDA E2B(R3) reports.
- Generate Localized Case Assessments and Expectedness for all Case Product Registrations on the Localized Case to calculate due dates at the Transmission level or for each Localized Case Assessment.
You can configure the following Japan-specific Localization fields:
- Assessment Generation: This field enables Localized Case Assessment generation based on Japan Case Product Registrations. Select how Vault generates case assessments as follows:
- Leave this field blank to generate domestic or localized case assessments and expectedness for each Case Product and Case Adverse Event pair.
- When you run the Evaluate Reporting Obligations action on reportable domestic Cases and Localized Cases in this Localization, Vault generates Transmissions and populates Due Dates on Transmission records. Due date calculations are affected by the setting in the Localized Due Date Calculation field.
- Select Localized Assessments for Case Product Registrations to generate Localized Case Assessments and Expectedness for each Case Product Registration and Case Adverse Event pair.
- When you run the Evaluate Reporting Obligations action on reportable Localized Cases in Japan, Vault does not generate Transmissions. Instead, Vault populates the Due Date and Due in Days value for each reportable Localized Case Assessment. Due date calculations are affected by the setting in the Localized Due Date Calculation field.
- You must use this setting to calculate Due Date and Due in Days values on Localized Case Assessments from Japan domestic Cases. The Calculate Due Dates on LCA action generates these calculations.
- On domestic Cases for Japan, Vault does not generate Case Assessment Expectedness records for Case Products with registrations that are reportable to the PMDA. Instead, expectedness evaluations appear on Localized Case Assessment records. At the Case-level, Expectedness is set using the most reportable evaluation across all non-PMDA Case Assessment Expectedness records and Localized Case Assessments from the Japan Localized Case.
- Leave this field blank to generate domestic or localized case assessments and expectedness for each Case Product and Case Adverse Event pair.
- Localized Due Date Calculation: When the Assessment Generation field is set to Localized Assessments for Case Product Registrations, you can select the method for calculating Due Dates on Localized Case Assessments for Japan as follows:
- Select Global Case - New Info Date to calculate the due date based on the New Info Date and Due in Days values.
- If the New Info Date is blank, Vault uses the Receipt Date.
- Select Localized Case - Local Awareness Date to calculate the due date based on the Local Awareness Date and Due in Days values.
- If the Local Awareness Date is blank, Vault uses the New Info Date, if available, or the Receipt Date.
- Select Global Case - New Info Date to calculate the due date based on the New Info Date and Due in Days values.
Add Japan Product Registration Details
The following Japan Product Registration fields map to Localized Case Products:
| Section > Field | Description |
|---|---|
| Details > Organization | Vault populates a link to the Organization on the parent Product. We recommend limiting this value to fewer than 60 characters to respect the G.k.3.3 Name of Holder / Applicant data element specification on PMDA E2B(R3) files. Vault truncates longer values on Case Product Registration records. |
| Details > Product Variant | Select the registered presentation or product variant. Vault populates this field based on data received from the Safety-RIM Connection. When generating Case Product Registrations for Case Products that are part of a Combination Product, for Product Constituents that include Product Variants, Vault matches only PMDA Product Registrations with the same variant. For Product Constituents without a Product Variant, Vault considers all PMDA Product Registrations when generating Case Product Registrations. |
| Details > Registration Type | Select the type of registration. When reporting to the PMDA, this identifies investigational from postmarket registrations. For a list of available Registration Types, navigate to Business Admin > Objects > Controlled Vocabularies. In the Agency filter, select the PMDA checkbox, and in the Type filter select the Registration Type checkbox. |
| Details > Country | Select Japan. |
| Registration Details > Local Product Code | Enter the region-specific product code on postmarketing Japan Product Registrations. Do not populate this field for investigational registrations. Vault maps this value to the Local Product Code field on Japan Case Product Registrations. |
| PMDA > Japan Product Code Type | Select the classification of the local product code for Japan. Vault maps this value to the Japan Product Code Type field on Japan Case Product Registrations. |
| PMDA > Clinical Compound Number | Enter the Clinical Compound Number (CCN). When setting up Investigational Product Registrations, the PMDA requires a CCN. Do not populate this field for Postmarketing registrations. When reporting Study Cases for Clinical Trial Studies registered in Japan, enter the CCN on the Study Registration record to export that value to the J2.12 Clinical Compound Number (CCN) data element of PMDA E2B(R3) reports. |
| PMDA > Product (Reported) Override | Enter a value to map to Case Product Registrations. This value is used when processing foreign Cases for Japan, where the Case includes Products registered to Japan but the Case Reporter Country is not Japan. Upon PMDA E2B(R3) generation, Vault exports this value to the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element. This field supports the scenario when a foreign Case Product has multiple investigational registrations with studies conducted in Japan with the same Substance. |
| PMDA > OTC Drug Classification | Select the PMDA OTC Drug Risk category. Upon PMDA E2B(R3) generation, Vault exports this value to the J2.5.k Classification of OTC drugs data element. |
| PMDA > Dose Form | Select the dose form. |
| PMDA > Device/Product Generic Name | Enter the generic name of the product to be reported to the PMDA. |
| PMDA > JMDN Code | When the generic name of the device or product is in the Japan Medical Device Nomenclature (JMDN), enter the associated JMDN code. |
| PMDA > Device Classification 1 | Select the Device Classification 1 of the device to be reported to the PMDA. |
| PMDA > Device Classification 2 | Select the Device Classification 2 of the device to be reported to the PMDA. |
| PMDA > Device Classification 3 | Select the Device Classification 3 of the device to be reported to the PMDA. |
| PMDA > Regenerative Classification | Select the Regenerative Classification of the device to be reported to the PMDA. |
Add a Japan Localized Substance
You can add Japan Localized Substances. To specify the region for the Localized Substance, in the Localization field select (Japanese) Japan.
Add a Japan Dose Form Code
Complete the following steps to add a three-letter E2B Code to a Dose Form. Users can select this code during Case data entry. When entered on Cases, Dose Form Codes are exported to the G.k.4.r.9.1 Pharmaceutical Dose Form (free text) data element of PMDA E2B(R3) reports.
- Go to Business Admin > Objects > Dose Form and select the Dose Form to which you want to add the E2B Code.
- Expand the Localizations section and then select Create.
- On the Create Localized Substance page, complete the fields. See the table below for Japan-specific sections and fields.
- Select Save.
Japan Dose Form Fields
| Field | Description |
|---|---|
| Name | Enter a name for the Dose Form. |
| Localization | Select (Japanese) Japan. |
| Dose Form | The referenced Dose Form. |
| E2B Code | Enter the three-letter E2B Code for the Dose Form. |
Add Japan Study Information
When you add Study information, Vault populates PMDA information on localized study cases for Japan. You can populate the following Japan-specific Study field:
- Development Phase: Select the development phase of the study. Vault exports this value to the J2.13.r.3 data element of PMDA E2B(R3) files.
Add a Japan Localized Study
To support populating required details on PMDA E2B(R3) files, you can add a Localized Study for Japan. The following Japan-specific fields may be available in the PMDA section:
| Section > Field | Description |
|---|---|
| Number of Clinical Trial Notifications | Enter the number of clinical trial notifications submitted to the PMDA for this study. Vault maps this value to the J2.13.r.1 data element of PMDA E2B(R3) files. |
| Existence of Subjects | Select whether subjects are present in this study. Vault maps this value to the J2.13.r.4 data element of PMDA E2B(R3) files. |
| Target Disease | Describe the disease being studied. Vault maps this value to the J2.13.r.2 data element of PMDA E2B(R3) files. |
| Dates of Clinical Trial Notification | Using the format YYYYY/MM/DD, enter the date the clinical trial notification was submitted to PMDA. Comma-separate multiple dates. |
| Primary Investigational Product Category | Enter the category of the primary study product described in the clinical trial notification. |
| Study Device Classification | For device clinical trials, select the device classification of the primary study product. |
Add a Japan Study Registration
When you add Study Registrations for Japan, you can populate the following Japan-specific field:
- Clinical Compound Number: Enter the Japan Clinical Compound Number (CCN) of the investigational drug. This field appears only when the Country of the registration is Japan. When reporting study cases for clinical trial studies registered in Japan, Vault maps this value to the J2.12 data element of PMDA E2B(R3) files. If this field is blank, Vault maps the CCN of the primary Case Product Registration from the Local Reporting Details section of the Case.
Specify the Primary Investigational Product for Blinded Study Arm Products
For blinded Products in blinded Study Arms, you can specify the primary blinded investigational Product when multiple investigational Products are included in the blinded Product, which Vault uses to calculate reportability to the PMDA. For more information, see Blinded Study Product Reporting in Report to the PMDA.
Add primary blinded investigational Products to Study Product Placeholders as follows:
- Navigate to a Study record at Business Admin > Objects > Studies.
- Add a Study Arm Product or navigate to an existing record under Study Arm Products.
- Click Edit on the Study Arm Product record.
- In the Blinded Name field, create a Study Product Placeholder record or select an existing Study Product Placeholder record to edit.
- In the Primary Blinded Investigational Product field, select a Product.
- Select Save.
Create Japan Organizations (Non-PMDA Only)
Vault includes the Japan regulatory agency PMDA. If you prepare submissions for the PMDA only, you can skip these steps. For other Japan reporting destinations, such as Partner Distributions, create an Organization as follows:
- Navigate to Business Admin > Objects > Organizations and create or open the Organization.
- In the Localization field of the Organization, select Japanese (Japan).
- Expand the Localized Organization section, and create a Localized Organization.
- To automatically generate Japan Localized Cases when reporting obligations are evaluated, set up reporting rules for the destination organization.
Controlled Vocabulary Types
Vault includes Controlled Vocabularies that contain standard ICH-based terminologies used to describe or code information on a Case. The Controlled Vocabulary types listed in this section are specific to reporting to the PMDA.
Completeness
This Controlled Vocabulary type maps to the Completeness field for entering data about the case completeness on each reporting Case. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.7.1 Completion flag.
Development Phase
This Controlled Vocabulary type maps to the Development Phase field to determine which options are available in that field for entering study information. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.13.r.3 Development phase.
Literature Classification
This Controlled Vocabulary type maps to the Literature Classification field on the document for classifying the literature document. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.17.r Classification of trial/research.
OTC Drug Channel
This Controlled Vocabulary type maps to the OTC Drug Channel field for entering data about from where the reported OTC drug obtained. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.6.k Obtaining channels for OTC drugs.
OTC Drug Classification
This Controlled Vocabulary type maps to the OTC Drug Classification field for entering data about the classification of OTC drugs. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.5.k Classification of OTC drugs.
PMDA Reporting Category
This Controlled Vocabulary type maps to the PMDA Reporting Category field for entering data about the reporting category for PMDA. This Controlled Vocabulary maps to PMDA E2B (R3) data element J2.1a PMDA Reporting Category.
Registration Type
This Controlled Vocabulary type determines which options are available in the Registration Type field for entering registration information while adding a product to the Product Library.
The Registration Category field is specific to the Registration Type Controlled Vocabulary.
You can categorize a Registration Type as either Investigational or Marketing. The Registration Category is considered during cross reporting evaluation.
Special Report Classification and Reporting Rules
Vault supports coding cases with the following PMDA special report classifications:
- Safety Measures Report
- Research Report
The Special Report Classification reporting rule parameter is evaluated when Cases may be reportable to the PMDA. If this parameter is set to “No”, the rule is evaluated when the Special Report Classification field is blank.
When evaluating reporting rules, Cases with Special Report Classification values are always excluded unless this parameter is specified in the Safety Rule Set.
For general information on reporting rule parameters, see Reporting Rule Parameter Reference.
Optionally, contact Veeva Managed Services to have additional options created for this field. This is useful in situations when Cases should be reported to certain destinations only.