Manage Products in Vault Safety

Add product, registration, and substance details in your company Product library

About Product Administration

Configure a Product with product, registration, and substance details for each product on which your organization monitors and reports. Optionally, create Product Families for an Organization to group Products with the same Substance. Product Families can include Datasheets, which are applied to all Products in the family without a specified Datasheet. This provides an easy way to manage large groups of Products.

Product setup is a prerequisite for adding Study Products and Combination Products.

Your company Product library is a key component in many Vault Safety features, which includes the following functionalities:

  • E2B Import: During an E2B import, the system attempts to match products in the E2B file to products configured in the Product library.
  • ICSR Report Generation: When the system generates ICSRs (including E2B, FDA 3500A, and CIOMS I reports) certain fields are mapped from the Product library. These fields are identified in their descriptions below.
  • Aggregate Reports: Products added to an aggregate report Reporting Family are used to filter Cases to include in report tabulations.
  • Reporting Rules: The system looks at local Product Registrations for Case Products to generate Submissions according to reporting rules in your Vault.
  • Watchlists: You can set up Watchlists to monitor Cases with certain Products. Case Products must be suspect or interacting to trigger watchlists.
  • Automatic Expectedness and Listedness: Set up Products and Product Datasheets for Vault Safety to automatically determine whether an adverse event is expected or unexpected.

Create Products

Add a Product for each company product for which you will process Cases in Vault Safety.

To support organization and maintenance of your Product library, products can be grouped in Product Families. All Products with a Product Family must have the same Substance and be linked to the same Organization.

Snapshotting: When you add a Case Product linked to a record in the company Product library, the system snapshots pre-configured product fields to the Case Product.

Add a Product Family

To add a Product Family:

  1. Go to Business Admin > Objects > Product Families.
  2. On the Product Families page, select Create.
  3. Complete the fields on the Create Product Family page.
  4. Select Save.

Product Family Fields

Field Description
Name
(name__v)		 Enter a name for the Product Family.
Organization
(organization__v)		 Select the Organization to which the Product Family belongs.
API Name
(api_name__v)

Enter a unique API Name for the Product Family.

The Product Family reporting rule parameter uses this value to determine if a Case Product belongs to this Product Family.

Family Datasheet
(datasheet__v)		 Add a Datasheet that applies to all Products within the Product Family that do not have a specified Datasheet. If the Product Family Datasheet changes, those updates are automatically applied to those Products.
Therapeutic Area
(therapeutic_area__v)		 Select the Therapeutic Area for the Product Family.

Result

When a Product Family record is saved, a Products section appears. You can create new Products that will be included in the Product Family by selecting Create on this page. If Products are set up separately and linked to a Product Family, they are automatically listed in the Products section.

Add a Product

To add a Product:

  1. Go to Business Admin > Objects > Products.
  2. On the Products page, select Create.
  3. In the Create Product window, select the product type, and then select Continue.
    • If the Product has multiple Product Type registrations to meet agency requirements, select Product. If not, select from the other options. When you select a product type registered in the FDA’s jurisdiction, the product type determines how the system automatically generates submissions to the FDA.
  4. Complete the fields on the Create Product page.
  5. Select Save.

Product Fields

Field Description
Organization
(organization__v)

Select the Organization to which the product belongs.

When adding a Case Product, the Case must be associated with this organization to allow users to select this product.
Product Name
(name__v)

Enter the primary name of the product. Vault Safety references the product using the name that you enter in this field.

When a Case Product references this Product record, the system uses this field to generate the Case Product Name.
Product Family
(product_family__v)		 Select the Product Family to which the Product belongs.
Abbreviation
(abbreviation__v)

Enter the abbreviated name for the product.

This field is for reference only.
Generic Name
(generic_name__v)

Enter the generic name for the product.

For Device-type products, this field is used in report generation for FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A report formats.
Vaccine Type
(vaccine_type__v)

If the product is a vaccine, select the vaccine type.

When a Vaccine-type Case Product references this Product record, the system snapshots this field to the Case Product.
International Birthdate
(international_birthdate__v)

Enter the date when a regulatory authority first granted marketing authorization for the product.

This field is used in report generation for the FDA MedWatch 3500A format (G.5 Pre-1938).
Expiration Date
(case_product_expiration_control__v)

Enter the expiration date for the product. Partial dates are supported and the minimum precision required is the year.

The system snapshots this field to the Case Product. For Device-type products, this field is used in report generation for FDA E2B(R2) (B.4.k.2.4.FDA.1).
Manufacturer
(manufacturer__v)

Select the organization that manufactures the product, if it is different from the one selected in the Organization field.

For Device-type products, this field is used in report generation for FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A report formats.
Core Datasheet
(datasheet__v)

Select the Core Datasheet for the product family.

Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.
Non-Company Product
(non_company_product__v) 		If selected, the system will consider Marketing→Investigational and Marketing→Marketing (Cross-Agency) cross reporting scenarios for the Product.
API Name
(api_name__v)

Enter a unique identifier that can be used with the Safety Rule "Product" parameter to define a specific Product for a reporting rule.

To learn more, see Reporting Rule Parameter Reference.
Market Segment
(market_segment__v)

Select a Market Segment from the picklist.

This field does not appear on layouts by default. Depending on your organization's security configuration, it may be added by your Admin.

Add Product Registration Details

Add Product Registrations for each country the product is registered in.

The system looks at the Product Registration Countries for Case Products to generate Submissions according to reporting rules in your Vault. Understand Reporting Rules provides more information.

Snapshotting: When you select the Product Registration on a Case Product, upon saving the record, the system snapshots fields from the Product Registration to the Case Product.

Add a Product Registration

Add product registration details for each country the product is registered in.

  1. Go to the Product record. Find Product records on the Business Admin > Objects > Products page.
  2. Under Registrations, select Create.
  3. Complete the Create Product Registration page.
  4. Select Save.

Product Registration Fields

Field Description
Organization
(organization__v)

The system automatically populates this field with a reference link to the Organization on the parent Product record.

If the Registration Applicant/Holder field is blank, the system snapshots this field to the Registration Holder field on Case Products.
Product
(product__v)		 The system automatically populates this field with a reference link to the Product parent record.
Registration Name
(name__v)		 (Required) Enter a name for the Product Registration. Vault Safety references the registration using the name that you enter in this field.
Product Type
(product_type__v)		 The system automatically populates this field with the product type of the Product parent record.
Combination Type
(combination_type__v)

If the product is a combination product, select the combination type.

The system snapshots this field to the Case Product and is used in report generation for the FDA VAERS E2B(R3) format.
Registration Number
(registration_number__v)

Enter the product authorization or application number for the country where the product is marketed.

For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

The system snapshots this field to the Case Product and is used in report generation for E2B, FDA MedWatch 3500A, and PADER formats.
Registration Date
(registration_date__v)

Enter the date when the product was registered.

This field is for reference only.
Registration Type
(registration_type__v)

Select the registration type.

This field is used in report generation for FDA MedWatch 3500A and PADER formats.

This field is needed to correctly match Transmission Profile Scope records for any Organization with multiple Transmission Profiles for the same destination Agency.

Country
(country__v)

Select the country where the product is registered and authorized.

The system snapshots this field to the Registration Country field on a Case Product and is used in report generation for E2B formats.
Route of Administration
(route_of_administration__v)

Select the route of administration TermID code.

This field is for reference only.
Compounding Type
(compounding_type__v)

If the product is a compounded product, select the compounding type.

The system snapshots this field to the Case Product and is used in report generation for E2B formats.
Agency
(agency__v)

Based on the Country selected on the Product Registration, the system automatically populates this field with the Agency assigned jurisdiction over that country.

If configured, reporting rules generate Submissions to this Agency when a Case Product references this Product Registration.
Transmission Profile
(transmission_profile__v)

To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.
Local Datasheet
(datasheet__v)

Select the Local Datasheet for this product registration. A Local Datasheet is specific to a country or region, listing expected adverse events that apply to that product registration.

Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.
Registration Applicant/Holder
(registration_holderapplicant__v)

The system snapshots this field to the Registration Holder field on Case Products. If this field is blank, the value in the Organization field is snapshot instead.
MAH
(reporting_organization__v)

This field may also be named Reporting Organization depending on your Admin's configuration.

If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.
Registered As
(transmission_product_type__v)

Select the product type for this registration from the following options:

  • Drug
  • Biologic
  • Device
  • Vaccine
  • Combination Product
  • Nutritional
  • Cosmetic
  • OTC Drug
  • OTC Device

The system snapshots this field to the Case Product Registered As field.

When generating E2B Transmissions for this registration, the system snapshots this field, then uses that value to determine whether Device-type Combination Product Constituents are exported.

See Exclude Device Constituents from E2B Exports for more information.

When generating an FDA 3500A form for a non-Combination Company Product, this field determines which section of the form is populated, as follows:

  • If the Registered As field is set to Device or OTC Device, populate the Suspect Medical Device sections.
  • If the Registered As field is not set to Device or OTC Device, populate the Suspect Product(s) section.
  • If the Company Product has multiple FDA registrations (one device, and one non-device, for example), populate the Suspect Product(s) section.
  • If the Company Product has no FDA registration, populate the Suspect Product(s) section.

For information on how the product type for a registration is used when evaluating reporting rules, see the Product Registration Type rule parameter.

This field does not appear on layouts by default, but can be added to Transmission layouts by your Admin. Depending on your Admin's configuration, this field may be called Transmission Product Type.
Default Registration
(default_registration__v)		 Designates the registration as the most current or commonly used registration for the selected country.
If the registration is the most commonly used for the selected country, select the checkbox. During data entry, in the Case Product Registration field, this registration is prioritized in the picklist, though all active Product Registrations remain available for use.
Strength
(strength_number__v | strength_unit__v)		 Enter the strength of the product.
In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.
MPID
(mpid__v)

Enter the Medicinal Product Identifier (MPID) for the product.

The system snapshots this field to the Case Product and is used in report generation for E2B(R3) and CIOMS I formats.
PhPID
(phpid__v)

Enter the Pharmaceutical Product Identifier (PhPID).

The system snapshots this field to the Case Product and is used in report generation for E2B(R3) and CIOMS I formats.
National Drug Code
(ndc__v)

Enter the US National Drug Code (NDC) or unique identifier for the product.

This field is used in report generation for the FDA MedWatch 3500A format.
Product Code
(product_code__v)

Enter the device Product Code.

The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A report formats.
Local Product Code
(local_product_code__v)		 Enter the region-specific Medicinal Product Identification (MPID) code. This field is used for Localized Cases.
Trade Name
(trade_name__v)		 The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2) (B.4.k.20.FDA.1).

PMDA Fields

Use the PMDA fields to set up regional information when adding Japan Product Registrations.

Make a Product Registration Inactive

You can set a Product Registration record to a Deleted state type so that the Safety Rule Engine no longer considers it when determining a Case’s reportability. With this setup, if the Product Registration was used in any existing Cases, it is available for follow-up scenarios.

To use this feature, your Admin must enable Inactivate Product & Study Registrations.

Complete the following steps to make a Product Registration inactive:

  1. In the Product Registration record, select the State button and select Deprecated from the picklist. Depending on your Admin’s configuration, the inactive state may have a different label.
  2. In the Change Object Status dialog, select Yes.

Similarly, if you need to reactivate the record, complete the steps detailed above but select Active from the picklist.

Add Substances

Configure substance information to snapshot information to Cases for E2B export as follows:

  • E2B(R3): Section G.k.2.3.r Substance / Specified Substance Identifier and Strength
  • E2B(R2): Data element B.4.k.2.2 Substance / Specified Substance Name

PSUR aggregate reports can leverage Substances to filter Cases to include in the report tabulations. Other aggregate reports do not leverage Substances.

Your Admin may need to configure your Vault to access this feature. See Enable Substances for more information.

Snapshotting: When a Case contains a Case Product linked to a company Product with pre-configured Substances, the system snapshots each Substance to create Case Product Substance records.

Add a Substance to a Product

To add a Substance to a Product:

  1. On the Product page, expand Substances, and then select Add. Your Admin may need to configure your Vault to insert the Substance section on the Product layout.
  2. Use any of the following methods to add a Substance:
    • Select existing Substances from the library, and then select OK.
      In the Search: Substance window, use filters to refine your search.
    • Select Create. On the Create Substance page, enter the substance details, and then select Save.
      You can also add a Product to a Substance by going to Business Admin > Objects > Substances. Create or select a Substance, and then expand Products.
  3. Select OK.

Product Substance Fields

Field Description
Substance Name
(name__v)

(Required) Enter the name of the substance. Vault Safety references the substance using the name that you enter in this field.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B(R2) and E2B(R3) formats.

This field supports up to 128 characters. If your Admin has configured your Vault for 250-character Substance Names, this field may be unavailable and have a different field name.
Substance Name
(substance_name__v)

(Required) Enter the name of the substance. Vault Safety references the substance using the name that you enter in this field.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B(R2) and E2B(R3) formats.

This field supports up to 250 characters. Your Admin must enable this field in your Vault.
Organization
(organization__v)		 (Required) Select the organization or use the binoculars icon to search for the organization associated with the substance.
Substance ID
(substance_id__v)

Enter the unique identifier for the substance.

This field is for reference only.
Term ID
(termid__v)

Enter the substance TermID.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B(R3) formats.
Term ID Version
(termid_version__v)

Enter the version date or number for the TermID.

The system snapshots this field to the Case Product Substance and is used in report generation for E2B(R3) formats.
Description
(description__v)

Enter a description for the substance.

This field is for reference only.

Create Product and Substance Aliases

During E2B or JSON import, Vault attempts to match the Case Product with the relevant Product in the Business Admin library.

You can set up Product matching using Product and Substance Aliases. If Vault cannot find a match for the Case Product using non-Study matching, it will attempt to use aliases you set up in the Business Admin library.

Add a Product Alias

To add a Product Alias:

  1. Go to Business Admin > Objects > Product Aliases.
  2. Select Create.
  3. Complete the following information:
  4. Select Save.

Result

You have saved the alias in the Product Aliases library. Now, Vault can match any Case Product with this alias to the associated Product in the Business Admin library. The Generic and Localized Product Names are automatically added from the Product record as Product aliases.

About Product Alias Matching

The Product Alias matching logic uses the Organization field and the following Product fields on Inbox Items for additional matching:

  • Country Obtained
  • Dose Form
  • Patient ROA
  • Dosage
  • Dose Strength and Unit

If the imported product still matches with more than one (1) library Product Alias, Vault checks if either of them is set as the Default Alias and selects this library Product Alias for auto-coding. Vault also looks for the Default Alias if no Inbox Item Product fields match between the imported product and the library Product Alias.

If there is no Default Alias, Vault does not code the product. If multiple Default Aliases are configured, Vault uses the one (1) with the latest modified date.

Add a Substance Alias

Consider adding Substance Aliases for Cases where users mistakenly enter a Substance Name as the Product.

To add a Substance Alias:

  1. Go to Business Admin > Objects > Substance Aliases.
  2. Select Create.
  3. Complete the following information:
    • Substance: (Required) Select the Substance the alias is associated with.
    • Alias: (Required) Enter the alias name.
  4. Select Save.

Result

You have saved the alias in the Substance Aliases library. Now, the system can match any Case Product with this Substance alias to the associated Substance in the Business Admin library and, subsequently, to the associated Product in the library.

The Localized Substance Name is added as an alias automatically.

Bulk Import Product and Substance Aliases Using Vault Loader

You can use Vault Loader to load Product and Substance Aliases in bulk from a Company Product in the Vault Library. Note that you must repeat the instructions below to upload two different CSV input files for Product Aliases and Substance Aliases.

The procedure for bulk importing Product and Substance aliases is as follows:

Prepare the CSV Input File

You can prepare CSV input files for Product and Substance aliases.

Prepare the Import File for Product Aliases
  1. Use Vault Loader to extract the Product Aliases fields. Keep only the Field Names, which will serve as the column headers for the import file. See Vault Loader: Create, Update & Delete Object Records for more information.
  2. Use Vault Loader to extract the following Product (product__v) fields:
    • Product Name (name__v)
    • Organization (organization__v)
    • Generic Name (generic_name__v)
  3. Copy the extracted fields from step 2 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
    FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
    Product Name name__v product__v
    Organization organization__v organization__v
    Generic Name generic_name__v alias__v
  4. Use Vault Loader to extract the following Localized Product (localized_product__v) fields.
    • Name (name__v)
    • Product (product__v)
    • Organization (organization__v)
  5. Copy the extracted fields from step 4 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
    FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
    Name name__v alias__v
    Product product__v product__v
    Organization organization__v organization__v
  6. In the import file, perform the following steps:
    • Capitalize the fields under the Alias (alias__v) column.
    • Go through the aliases and remove any duplicates.
Prepare the Import File for Substance Aliases
  1. Use Vault Loader to extract the Substance Aliases fields. Keep only the Field Names, which will serve as the column headers for the import file. See Vault Loader: Create, Update & Delete Object Records for more information.
  2. Use Vault Loader to extract the following Substance (substance__v) fields:
    • Substance Name (name__v)
    • Organization (organization__v)
  3. Copy the extracted fields from step 2 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
    FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
    Substance Name name__v substance__v
    Organization organization__v organization__v
  4. Use Vault Loader to extract the following Localized Substance (localized_substance__v) fields.
    • Name (name__v)
    • Substance (substance__v)
    • Organization (organization__v)
  5. Copy the extracted fields from step 4 into the import file under the respective column. The following table displays the field mapping between the extracted file and the import file columns:
    FIELD LABEL EXTRACTED FIELD NAME IMPORT FIELD NAME
    Name name__v alias__v
    Substance substance__v substance__v
    Organization organization__v organization__v
  6. In the import file, perform the following steps:
    • Capitalize the fields under the Alias (alias__v) column.
    • Go through the aliases and remove any duplicates.

Load Aliases into Your Vault

Vault Help provides instructions on using Vault Loader to upload object records to your Vault. Follow the steps in Vault Loader: Create, Update & Delete Object Records to load object records with your respective CSV input file.

Note the following when completing the steps:

  • In the Action Type dropdown menu, select “Upsert”.
  • In the Key Field dropdown menu, select “Alias”.

Create Inactive Ingredients

Add an Inactive Ingredient record for each Inactive Ingredient for which you will process Cases in Vault Safety.

Add Inactive Ingredients

  1. Go to Business Admin > Objects > Inactive Ingredients.
  2. On the Inactive Ingredients page, select Create
  3. Complete the fields on the Inactive Ingredients page:
    • Name (name__v): Enter a name for the Inactive Ingredient record.
    • Organization (organization__v): Select the Organization to which the Inactive Ingredient belongs.
    • Inactive Ingredient Name (inactive_ingredient_name__v): Enter the name of the Inactive Ingredient.
  4. Select Save.

Add Inactive Ingredient Registrations

Add Inactive Ingredient Registrations for each country the Inactive Ingredient is registered in. Inactive Ingredient Registrations are linked and automatically added to Product Registration and Inactive Ingredient records.

  1. Go to the Inactive Ingredient or Product Registration record page.
    • Find Inactive Ingredient records on the Business Admin > Objects > Inactive Ingredients page.
    • Find Product Registration records on the Business Admin > Objects > Product page, under Product Registrations.
  2. Under Inactive Ingredient Registrations, select Create.
  3. Complete the fields on the Inactive Ingredient Registrations page:
    • Name (name__v): Enter a name for the Inactive Ingredient Registration record.
    • Organization (organization__v): This is populated with the Organization name from the parent record.
    • Inactive Ingredient (inactive_ingredient_v): Select the Inactive Ingredient. If you access this page through the Inactive Ingredient record, this field is automatically populated.
    • Product Registration (product_registration__v): Select the associated Product Registration. If you access this page through the Product Registration record, this field is automatically populated.
  4. Select Save.