Create Inbox Items from Literature Articles

Learn how to create Inbox Items from ICSRs detected in Literature Articles.

About Creating Inbox Items from Literature Articles

If you detect ICSRs during literature article reviews, you can create Inbox Items in Vault Safety directly from SafetyDocs Literature Article records. With this integrated approach to case processing, Vault populates relevant fields, reducing the need for manual data entry.

Based on the number of products and patient groups in a literature article, you can create up to 100 Inbox Items from a single Literature Article. Vault creates Inbox Items based on the number of products and review outcomes:

• Single Product Scenario: If a Literature Article includes one (1) Product, Vault creates one (1) Inbox Item.
• Multiple Products on a Single Set of Cases Scenario: If a Literature Article includes multiple Products, but only the rank 1 Product has review outcomes, Vault creates one (1) Inbox Item. The Inbox Item includes all of the Products from the Literature Article, ranked based on the Rank field on the applicable Literature Article Product record.
• Multiple Cohort Scenario: If a Literature Article includes multiple Products with review outcomes, Vault creates an Inbox Item for each Literature Article Product record as follows:
  • If there are confirmed ICSRs and the Special Report Classification Outcome field is blank, Vault creates one (1) Inbox Item and maps the value in the Number of Identified Cases field on the Literature Article Product record to the Number of Cases field on the Inbox Item.
  • If there are confirmed ICSRs and the Special Report Classification Outcome field is populated, Vault creates two (2) Inbox Items and maps the value in the Number of Identified Cases field on the Literature Article Product record to the Number of Cases field on the Inbox Item. For one (1) Inbox Item, Vault also maps the value in the Special Report Classification Outcome field to the Special Report Classification field on the Inbox Item.
  • If there are no confirmed ICSRs and the Special Report Classification Outcome field is populated, Vault creates one (1) Inbox Item and maps the value in the Special Report Classification Outcome field to the Special Report Classification field on the Inbox Item.

For more information, see Import Literature References from Database Files.

Prerequisites

Consider the following prerequisites for creating Inbox Items from ICSRs found in literature articles:

• Your Vault must be licensed for both Vault Safety and Vault SafetyDocs. Contact your Veeva representative for more information.
• Your Admin must configure the following features in your Vault:
  • Literature Review Process Management
  • Creation of Inbox Items from Literature Articles
  • JAPIC Literature Intake
• Optionally, configure Literature Multi-Product Support to support independent verdicts for literature articles that include multiple products.

Create Inbox Items from a Literature Article

The Create Inbox Item from Literature action appears only if the selected Literature Article is in the Further Action in Progress state. To create Inbox Items from Literature Articles:

1. Navigate to the Literature Article record with detected ICSRs in either of the following ways:
   • Navigate to Literature > Literature Articles and select the applicable Literature Article.
   • Navigate to Literature > Literature Reviews and select the related Literature Review, and then expand the Literature Articles section and select the applicable Literature Article.
2. From the All Actions menu, select Create Inbox Item from Literature.

Literature Article to Inbox Item Field Mapping

Vault populates key fields on Inbox Items by mapping information from source Literature Article records as follows:

Field	Description
New Info Date	Mapped from the Access Date field on the source Literature Article record. If the Access Date is not available, this field is set to the date on which the source Literature Article record was created.
Report Type	Set to Literature (Spontaneous).
Product	Mapped from the Product field on the source Literature Article record, if available. Otherwise, Vault maps the Product on the associated Literature Review record.
Source Literature Review	Set as the Literature Review record that included the source Literature Article record for this Inbox Item.
Source Literature Article	Set as the Literature Article record in which the source ICSRs were found.
Number of Cases	Mapped from the Number of Identified Cases field on the source Literature Article record.
Intake Format	Set to Literature Article.
Intake Method	Set to Literature Promotion.
Source Document	Set to the document linked in the source Literature Article record (if available). If multiple documents are linked in the record, Vault picks the first one. Preference is given to articles classified as Full-Text.
Special Report Classification Outcome	Mapped from the Special Report Classification Outcome field on JAPIC-imported Literature Article records.
Organization	Vault sets this field as follows: Mapped from the Organization field on the source Literature Article record (if available). Otherwise, mapped from the Organization field on the associated Literature Review record (if available). If neither of the above fields contains a value, Vault sets the value of this field to that of your Organization.

The following results also take place:

• Vault creates a Case Contact record for each Literature Author on the source Literature Article record and maps relevant information.
• Vault creates an Inbound Transmission record with details from the newly created Inbox Item and adds it to the Inbox Item.
• If Case Access Group Security is enabled in your Vault, Vault matches the Inbox Item with the appropriate Case Access Group. For more information, see Manage Case Access Group Security.

Promote to Case or Multiple Cases

From the Inbox Item, you can initiate the Promote to Case or Promote to Multiple Cases actions from the All Actions menu as you would for any other Inbox Item.

After promotion, Vault maps information from the Inbox Item to populate the following Case fields:

• Source Literature Review
• Source Literature Article
• Source Document
• Number of Cases

The newly created Cases are linked on the Case field on all literature documents associated with the source Literature Article. All other case promotion processes run as expected. For more information, see Promote to Case and Promote to Multiple Cases.