Sections in This Article
- Localized Business Administration
- Set Up Localized Product and Substance Information
- Set Up Localized Study Information
- Create Japan Organizations (Non-PMDA Only)
Localized Business Administration
Vault Safety supports capturing data in fields required by regional agencies, such as the PMDA. Administrators can preconfigure certain data in the Business Admin vault library.
In vaults originally deployed in 20R3 or earlier, you must enable localized submissions and translation support before configuring localized Business Admin records.
Set Up Localized Product and Substance Information
Add a Japan Product Registration
- Go to Business Admin > Products and create the Product.
If the Product is already in your vault, go to the record.
- Under the Product, add a Product Registration child record.
- Set the Product Registration Country to Japan.
- Use the PMDA section to enter Japan product registration data.
Japan Product Registration Fields
|Registration Type||Select the product Registration Type.|
|Dose Form||Select the dose form.|
|Japan Product Code Type||Select the classification of the local product code for Japan.|
|Local Product Code||Enter the region-specific product code: J-Drug Code, OTC, or Temporal.|
|Clinical Compound Number||Enter the Japanese Clinical Compound Number (CCN) of the investigational drug.|
|OTC Drug Classification||Select the PMDA OTC Drug Risk category.|
Add a Localized Substance
- Go to Business Admin > Products and open the Product.
- Add the Substance under the Product.
If the Substance is already in your vault, open the Substance.
- Under the Substance, add a Localized Substance child record.
You may need to update the Substance page layout to add the Localized Substance related object section.
Japan Substance Fields
|Name||Enter the Japanese substance name.|
|Local Product Code||Enter the Japan local product code.|
|Localization||Select the locale for the regional data.|
|Substance||The referenced Substance record. The system automatically populates this field when you create the Localized Substance as a child object from the initial Substance.|
Add a Japan Dose Form Code
You can configure the 3-letter PMDA E2B Code for Dose Forms users can select during PMDA data entry.
- Go to Business Admin > Dose Form and open the Dose Form.
Under the Dose Form, you can see a Localized Dose Form.
- Open the Localized Dose Form child record.
- Set the value of E2B Code.
Set Up Localized Study Information
Add a Localized Study Information to automatically populate PMDA information for Localized Study Cases.
Add the Study
- Go to Business Admin > Studies and create the Study.
If the Study is already in your vault, go to the record.
- Specify the Development Phase field on the Study for PMDA submissions:
Field Description Development Phase Select the development phase of the study.
Add a Localized Study
- Open the Study.
- Under the Study, add a Localized Study child record.
You may need to update the Study page layout to add the Localized Study related object section.
Japan Localized Study Fields
|Localization||Select Japanese (Japan).|
|Study||The referenced Study record. The system automatically populates this field if you create the Localized Study as a child object from the initial Study.|
|Study Name||Enter the Japanese study name.|
|Target Disease||Describe the disease being studied.|
|Existence of Subjects||Select Yes or No, to indicate whether subjects are present in this study.|
|Number of Clinical Trial Notifications||Enter the number of clinical trial notifications submitted to the PMDA for this study.|
Create Japan Organizations (Non-PMDA Only)
Vault Safety includes Japan regulatory agency PMDA out of box. 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.
- Go to Business Admin > Organizations and create the Organization.
If the Organization is already in your vault, go to the record.
- On the Organization, set the Localization field to Japan.
You may need to update the Organization page layout to add this field.
- Under the Organization, add a Localized Organization child record.
You may need to update the Organization page layout to add the Localized Organization related object section.
- 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.