Managing Core Data

Vault Admins are responsible for creating and managing your organization’s product families and other core data. Creating the core data in advance can make it quicker and easier for your team to plan, track, author, review, and approve submission documents. Submission managers use this core data to create applications, submissions, and content plans.

Managing Core Product Data

Product families are the foundation of your core product data. After creating a product family, you can begin creating and adding product data to the product family using the following data structure:

Some product data must be added to product data that you have already created, so ensure that you create your data in the right order. We recommend you create your data in the following order:

1. First, create your Product Family.
2. Second, create the following data for your product and product family:
   • Products
   • Active Substances
   • Inactive Ingredients
   • Therapeutic Indications
   • Clinical Studies
   • Nonclinical Studies
3. Third, create the following data for your product variants:
   • Product Manufacturers
   • Product Variants
   • Product Variant Active Substances
   • Product Variant Inactive Ingredients
4. Last, create the following remaining data:
   • Active Substance Manufacturers
   • Inactive Ingredient Manufacturers
   • Study Sites

Creating Product Families

Complete the following steps to create a product family:

1. Navigate to the RIM Admin > Product Information tab and click Create.
2. On the Create Product Family page, enter the product family Name.
3. Optional: Enter the Alternate Name and Scientific Name.
4. Click Save. Vault creates the product family and displays the Product Family page, where you can create product information and other core data for the product family.

Creating Products

Complete the following steps to create a new product within a product family:

1. On the Product Family page for the product family for which you want to create a new product, click Add in the Products section.
2. Click Create in the Search: Product dialog.
3. From the Product Type list, select Product and click Continue.
4. In the Create Product dialog, enter the Product Name, select the Primary Product Family, and select the Manufactured Dosage Form.
5. Optional: If the product is a comparator product used in clinical trials, select Yes for Comparator Product. Otherwise, select No.
6. Click Save to create the product.
7. Ensure that the new product you created is selected in the Search: Product dialog and click OK. Vault adds the new product to the product family.

Creating Combined Products

A combined product is a product that combines multiple products into a single entity. First, create the combined product and add its details. Then, after saving the record, add each of the individual product components that make up the combined product.

Complete the following steps to create a combined product and add its product components:

1. On the Product Family page for the product family for which you want to create a new combined product, click Add in the Products section.
2. Click Create in the Search: Product dialog.
3. From the Product Type list, select Product (Combined) and click Continue.
4. In the Create Product (Combined) dialog, enter the Product Name, select the Primary Product Family, and select the Manufactured Dosage Form.
5. Optional: If the product is a comparator product used in clinical trials, select Yes for Comparator Product. Otherwise, select No.
6. Click Save to create the combined product. Vault selects the checkbox for the new combined product in the Search: Nonclinical Study dialog.
7. Click OK. Vault adds the combined product to the product family.
8. On the Product Family page, click the Product Name of the new combined product to open the Product (Combined) page.
9. Click Create in the Combined Product Components section.
10. In the Create Product Component dialog, enter a Name for the product component and select the Individual Product.
11. Select a Product Variant from the drop-down:
    • For an existing product variant, select the Product Variant name.
    • To create a new product variant, select Create Product Variant, enter the Product Variant name, select the Manufactured Dosage Form, and click Save.
12. Click Save in the Create Product Component dialog to add the product component to the combined product, or click Save + Create to add the product component and display a blank dialog where you can create another product component.

Creating Active Substances

Complete the following steps to add or create an active substance for a product family:

1. On the Product Family page for the product family you want to create an active substance for, click Add in the Active Substances section. The Active Substance dialog is displayed.
2. Determine whether to add an existing active substance or create a new active substance:
   • To add an existing active substance, select the checkbox for the active substance you want to add.
   • To create a new active substance, click Create, enter the Substance Name, select the Primary Product Family, and click Save. Vault creates the active substance and selects it in the dialog.
3. Click OK. Vault adds the active substance to the product family.

Creating Inactive Ingredients

Complete the following steps to add or create an inactive ingredient for a product family:

1. On the Product Family page for the product family you want to create an inactive ingredient for, click Add in the Inactive Ingredient section. The Inactive Ingredient dialog is displayed.
2. Determine whether to add an existing inactive ingredient or create a new inactive ingredient:
   • To add an existing inactive ingredient, select the checkbox for the inactive ingredient you want to add.
   • To create a new inactive ingredient, click Create, enter the Inactive Ingredient Name, select Yes or No depending on whether the inactive ingredient is a Novel Excipient, and click Save. Vault creates the inactive ingredient and selects it in the dialog.
3. Click OK. Vault adds the inactive ingredient to the product family.

Creating Therapeutic Indications

Complete the following steps to add or create a therapeutic indication for a product family:

1. On the Product Family page for the product family you want to create a therapeutic indication for, click Add in the Therapeutic Indication section. The Therapeutic Indication dialog is displayed.
2. Determine whether to add an existing therapeutic indication or create a new therapeutic indication:
   • To add an existing therapeutic indication, select the checkbox for the therapeutic indication you want to add.
   • To create a new therapeutic indication, click Create, enter the Name of the therapeutic indication, and click Save. Vault creates the therapeutic indication and selects it in the dialog.
3. Click OK. Vault adds the therapeutic indication to the product family.

Creating Clinical Studies

If your organization uses Vault Clinical Basics and has a RIM to Clinical connection, you can add existing studies created in Vault Clinical Basics to your product families. If you do not have a RIM to Clinical connection, you can create new clinical studies to add to product families.

Complete the following steps to add or create a clinical study for a product family:

1. On the Product Family page for the product family you want to create a clinical study for, click Add in the Clinical Study section. The Clinical Study dialog is displayed.
2. Determine whether to add an existing clinical study or create a new clinical study:
   • To add an existing clinical study, select the checkbox for the clinical study you want to add.
   • To create a new clinical study, click Create, enter the Clinical Study Number, select the Primary Product Family, enter any optional information, and click Save. Vault creates the clinical study and selects it in the dialog.
3. Click OK. Vault adds the clinical study to the product family.

Creating Nonclinical Studies

Complete the following steps to add or create a nonclinical study for a product family:

1. On the Product Family page for the product family you want to create a nonclinical study for, click Add in the Nonclinical Study section. The Nonclinical Study dialog is displayed.
2. Determine whether to add an existing nonclinical study or create a new nonclinical study:
   • To add an existing nonclinical study, select the checkbox for the nonclinical study you want to add.
   • To create a new nonclinical study, click Create, enter the Nonclinical Study Number, select the Primary Product Family, enter any optional information, and click Save. Vault creates the nonclinical study and selects it in the dialog.
3. Click OK. Vault adds the nonclinical study to the product family.

Creating Product Manufacturers

Complete the following steps to create a product manufacturer for a product:

1. On the Product Family page for the product family you want to create a product manufacturer for, click Add in the Product Manufacturer section. The Product Manufacturer dialog is displayed.
2. Determine whether to add an existing product manufacturer or create a new product manufacturer:
   • To add an existing product manufacturer, select the checkbox for the product manufacturer you want to add.
   • To create a new product manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the product manufacturer and selects it in the dialog.
3. Click OK. Vault adds the product manufacturer to the product family.

Creating Product Variants

Complete the following steps to create a product variant for a product:

1. On the Product Family page, click the Product Name of the product for which you want to create a variant.
2. On the Product page, click Product Variants in the left panel.
3. Click Create in the Product Variants section.
4. Enter the Product Variant name and select the Manufactured Dosage Form.
5. Click Save to create the product variant and add it to the product.

Adding Product Variant Active Substances

Before adding an active substance to a product variant, you must first create the active substance for the product.

Complete the following steps to add an active substance to a product variant:

1. On the Product Family page, click the Product Name of the product that contains the variant to which you want to add an active substance.
2. On the Product page, click Product Variants in the left panel.
3. Click the Product Variant name. The Drug Product Variant page is displayed.
4. On the Drug Product Variant page, click Product Variant Active Substances in the left panel.
5. In the Product Variant Active Substances section, click Create.
6. In the Create Product Variant Active Substances dialog, select the Active Substance from the drop-down.
7. Click Save to add the active substance to the product variant.

Adding Product Variant Inactive Substances

Before adding an inactive ingredient to a product variant, you must first create the inactive ingredient for the product.

Complete the following steps to add an inactive ingredient to a product variant:

1. On the Product Family page, click the Product Name of the product that contains the variant to which you want to add an inactive ingredient.
2. On the Product page, click Product Variants in the left panel.
3. Click the Product Variant name. The Drug Product Variant page is displayed.
4. On the Drug Product Variant page, click Product Variant Inactive Ingredients in the left panel.
5. In the Product Variant Inactive Ingredients section, click Create.
6. In the Create Product Variant Inactive Ingredient dialog, select the Inactive Ingredient from the drop-down.
7. Click Save to add the inactive ingredient to the product variant.

Creating Active Substance Manufacturers

Complete the following steps to create a manufacturer for an active substance:

1. On the Product Family page, click the Substance Name of the active substance to which you want to add a manufacturer.
2. On the Active Substance page, click Manufacturers in the left panel.
3. Click Add in the Manufacturers section. The Manufacturer dialog is displayed.
4. Determine whether to add an existing manufacturer or create a new manufacturer:
   • To add an existing manufacturer, select the checkbox for the manufacturer you want to add.
   • To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog.
5. Click OK. Vault adds the manufacturer to the active substance.

Creating Inactive Ingredient Manufacturers

Complete the following steps to create a manufacturer for an inactive ingredient:

1. On the Product Family page, click the Substance Name of the inactive ingredient to which you want to add a manufacturer.
2. On the Inactive Ingredient page, click Manufacturers in the left panel.
3. Click Add in the Manufacturers section. The Manufacturer dialog is displayed.
4. Determine whether to add an existing manufacturer or create a new manufacturer:
   • To add an existing manufacturer, select the checkbox for the manufacturer you want to add.
   • To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog.
5. Click OK. Vault adds the manufacturer to the inactive ingredient.

Creating Study Sites

Complete the following steps to create a study site for a clinical study:

1. On the Product Family page, navigate to the Clinical Studies section and click the Clinical Study Number of the clinical study for which you want to create a study site.
2. On the Clinical Study page, enter the Site name.
3. Optional: Enter the Principal Investigator name and select a Country.
4. Click Save to create the study site and add it to the clinical study.

Editing Product Family Information

Complete the following steps to edit product family information:

1. On the Product Family page, click Edit.
2. Edit the product family Name, Alternate Name, or Scientific Name as needed.
3. Click Save to save your changes.
4. To edit other information associated with the product family, navigate to the appropriate section and click the Name of the item you want to edit.
5. On the item’s page, click Edit, edit the information as needed, and click Save to save your changes.

Managing File Uploads

In some situations, you may need to import large files to Vault using an FTP client or request temporary access to Vault Loader to import a large quantity of data.

Configuring an FTP Client

If you need to import a submission larger than 4 GB to RIM Basics: Submissions Archive, you must first upload the submission folder and its files to Vault’s staging server using an FTP client. We recommend using FileZilla, but your IT department may require a different FTP client. Contact your IT department for more information or assistance configuring your FTP client.

Use the settings below to configure the FileZilla FTP client. Your settings may be different if you use a different FTP client.

• Protocol: FTP (File Transfer Protocol)
• Encryption: Require explicit FTP over TLS (FTPS). This is a security requirement. Your network infrastructure must support FTPS traffic.
• Port: This does not typically need to be added and defaults to Port 21. This setting may be different depending on your organization’s IT security settings.
• Host: {Domain Name}.veevavault.com. For example: veepharm is the domain name in veepharm.veevavault.com.
• Timeout: 180 seconds if uploading large files.
• User: {Domain Name}.veevavault.com+{User Name}. This uses the same user name that you log in with. For example: veepharm.veevavault.com+tchung@veepharm.com.
• Password: Your login password for this Vault. This is the same password used for your standard login. You can also use a valid session ID.
• Login Type: Normal
• Transfer File Type: Transfer files as binary

Requesting Loader Access

If your site has a large quantity of data or documents to upload to Vault, contact Vault Basics support for information about Vault Loader, which allows you to upload data or documents to Vault in bulk. Vault Basics support can help you determine whether Vault Loader is appropriate for your situation and can grant temporary access.