Set Up the Localized Business Admin Library for Japan

Set up Localized Product and Study information and configure Localizations for processing Cases for Japan.

About Setup for Processing Cases for Japan

Vault Safety 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 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 Safety, your Admin must review and enable PMDA-related features.

Add a Japan Product Registration

Complete the following steps to add a Japan Product Registration:

1. Go to Business Admin > Objects > Products and select the Product to which you want to add the registration.
   If the Product is not set up, see Create Products in Manage Products.
2. Expand the Registrations section, and then select Create.
3. On the Create Product Registration page, complete the fields.
   For information on general data entry, see Add Product Registration Details in Manage Products. See the table below for Japan-specific sections and fields.
4. Select Save.

Japan Product Registration Fields

Section > Field	Description
Details > Organization	Vault automatically populates this field with a reference link to the Organization on the parent Product record. We recommend limiting this value to a maximum of 60 characters to respect the G.k.3.3 Name of Holder / Applicant data element specification on PMDA E2B(R3) reports. If this value is longer than 60 characters, Vault truncates it on the Case Product Registration record.
Details > Registration Type	Select the Registration Type. When reporting to the PMDA, this identifies Investigational from Postmarketing registrations. For a list of available Registration Types, go 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. When setting up Postmarketing Product Registrations, the PMDA requires a Local Product Code. Do not populate this field for Investigational registrations.
PMDA > Japan Product Code Type	Select the classification of the local product code for Japan.
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 Registration records. 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.

Add a Japan Localized Substance

Complete the following steps to add a Japan Localized Substance to a Product Registration:

1. Go to Business Admin > Objects > Products and select the Product to which you want to add the Localized Substance.
   If the Product is not set up, see Create Products in Manage Products.
2. Expand the Substances section and then select the Substance to which you want to add the Localized Substance.
   If the Substance is not set up, see Add Substances in Manage Products.
3. Expand the Localizations section and then select Create.
4. On the Create Localized Substance page, complete the fields. See the table below for Japan-specific sections and fields.
5. Select Save.

Japan Substance Fields

Field	Description
Substance Name	Enter the Japanese substance name.
Substance	The referenced Substance record. Vault populates this field when you create the Localized Substance as a child object from the initial Substance.
Local Product Code	Enter the Japan local product code for the Substance.
Localization	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.

1. Go to Business Admin > Objects > Dose Form and select the Dose Form to which you want to add the E2B Code.
2. Expand the Localizations section and then select Create.
3. On the Create Localized Substance page, complete the fields. See the table below for Japan-specific sections and fields.
4. 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 record.
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.

Add a Study

Complete the following steps to add a Study:

1. Go to Business Admin > Objects > Studies and refer to Add a Study in Manage Studies.
   If the Study is already in your Vault, go to the record.
2. On the Create Study page, complete the fields.
   For information on general data entry, see Study Details Fields in Manage Studies.
   1. In the Development Phase field, select the development phase of the Study. Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.3 Development phase data element.
3. Select Save.

Add a Japan Localized Study

Complete the following steps to add a Localized Study for Japan:

1. Go to Business Admin > Objects > Studies and open the Study to which you want to add a Localized Study.
2. Expand the Localizations section and then select Create.
3. On the Create Localized Study page, complete the fields. See the table below for Japan-specific sections and fields.
4. Select Save.

Japan Localized Study Fields

Section > Field	Description
Details > Localization	Select (Japanese) Japan.
Details > Study Name	Enter the Japanese Study name.
Details > Study Type	This value is populated based on the parent Study record.
PMDA > Number of Clinical Trial Notifications	Enter the number of clinical trial notifications submitted to the PMDA for this study. Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.1 Number of CTN data element.
PMDA > Existence of Subjects	Select Yes or No to indicate whether subjects are present in this study. Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.4 Existence of subjects data element.
PMDA > Target Disease	Describe the disease being studied. Upon PMDA E2B(R3) generation, Vault exports this value to the J2.13.r.2 Study indications data element.

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:

1. Navigate to a Study record at Business Admin > Objects > Studies.
2. Create a new Study Arm Product or navigate to an existing record under Study Arm Products.
3. Click Edit on the Study Arm Product record.
4. In the Blinded Name field, create a Study Product Placeholder record or select an existing Study Product Placeholder record to edit.
5. In the Primary Blinded Investigational Product field, select a Product.
6. Select Save.

Add a Japan Study Registration

Complete the following steps to add a Study Registration for Japan:

1. Go to Business Admin > Objects > Studies and open the Study to which you want to add a Japan Study Registration.
2. Expand the Registrations section and then select Create.
3. On the Create Study Registration page, complete the fields.
   For information on general data entry, see Add a Study Registration in Manage Studies.
   1. In the Clinical Compound Number field, enter the Japan Clinical Compound Number (CCN) of the investigational drug. This field appears only if the Country field is set to Japan. When reporting Study Cases for Clinical Trial Studies registered in Japan, Vault populates this value in the J2.12 Clinical Compound Number (CCN) data element of PMDA E2B(R3) reports.
      If this field is blank, Vault maps the CCN of the primary Case Product Registration from the Local Reporting Details section of the Case.
4. Select Save.

Create Japan Organizations (Non-PMDA Only)

Vault Safety 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.

1. Go to Business Admin > Objects > Organizations and create the Organization.
   If the Organization is already in your vault, go to the record.
2. On the Organization, set the Localization field to Japan.
   You may need to update the Organization layout to add this field.
3. Under the Organization, add a Localized Organization child record.
   You may need to update the Organization layout to add the Localized Organization related object section.
4. Set up reporting rules for the destination organization.
   You must set up reporting rules to automatically generate Localized Japan Cases when reporting obligations are evaluated.

Set Up Localizations

You can configure Localization records to meet specific reporting needs and reduce manual effort when working on Domestic 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. This feature allows for calculating Due Dates at the Transmission level or for each Localized Case Assessment.

Manage Localizations

To manage Localization records, go to Business Admin > Objects > Localizations. When editing a record, reference the following table when populating fields.

Field	Description
Localization Type	The available Localization Types are Global and Local. The Localization Type impacts whether Inbox Items and Cases are processed as Global, Domestic, or Localized. Your Admin can configure your Vault to Auto-select Inbox Item Localization by Reporter Country.
Localization Scope	Localization Scope manages which fields are available for dual-language Domestic Case processing. Leave this field blank for the Localization Scope to include all fields. Otherwise, you can set the scope to only Narratives, Reporter Comments, or both. If configured, Vault exports the localized values for Reporter Comments and Narratives in E2B formats.
Assessment Generation	This field enables Localized Case Assessment generation based on Japanese Case Product Registrations. This feature is available only when reporting to the PMDA. 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 Adverse Event pair. With this setting, when you run the Evaluate Reporting Obligations action on reportable Domestic 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 Adverse Event pair. This option is supported only when working on Cases that are reportable to the PMDA. With this setting, when you run the Evaluate Reporting Obligations action on reportable Localized Cases in Japan, Vault does not generate Transmissions. Instead, Vault populates the Due Dates and Due in Days values for each reportable Localized Case Assessment record. 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. With this setting, on Domestic Cases for Japan, Expectedness records are not generated 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 Expectedness records and Localized Case Assessments from the Japan Localized Case. For information on how Vault evaluates the Most Reportable Case Product and Case Assessment, see Reporting Rules Product Selection. For more information on Localized Case Assessments, see Complete Intake and Process Cases for the PMDA.
Localized Due Date Calculation	When you set the Assessment Generation field 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 field 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 field is blank, Vault uses the New Info Date, if available, or the Receipt Date.

Controlled Vocabulary Types

Vault Safety includes Controlled Vocabularies that contain standard ICH-based terminologies used to describe or code information in a Vault Safety Case. For general information on this topic, see Configure Controlled Vocabularies.

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 Safety 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.