Learn how to create Inbox Items from ICSRs detected in Literature Articles.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Creating Inbox Items from Literature Articles
If ICSRs are detected in your Literature Article Reviews in Vault SafetyDocs, you can create Inbox Items from them to process as Cases in Vault Safety. With this integrated approach, Vault automatically populates relevant fields, reducing the need for manual data entry.
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 your Vault to use the features described on this page. The following pages provide more information:
Note: Creating Inbox Items from Literature Articles is not supported in CRO (multi-sponsor) Vaults.
Create an Inbox Item from a Literature Article
Complete the following steps to create Inbox Items from Literature Articles:
- Go to Literature > Literature Reviews and select the related Literature Review.
- Select the Literature Article record with detected ICSRs.
- From the All Actions menu, select Create Inbox Item from Literature.
Note: The Create Inbox Item from Literature action will appear only if the selected Article is in the Further Action in Progress state. Contact your Admin for more details.
Result
An Inbox Item is created in your Safety Inbox.
For JAPIC-imported Literature Article records, if the Special Report Classification Outcome field is populated and the ICSR Review Outcome field is set to Confirmed ICSRs, two (2) Inbox Items are created in your Safety Inbox:
- One (1) with the Special Report Classification Outcome field mapped from the Special Report Classification Outcome field on the JAPIC-imported Literature Article record.
- One (1) with the Special Report Classification Outcome field left blank.
For more information, see Import Literature References from Database Files.
Vault populates key fields on the Inbox Item by mapping information from the source Literature Article record 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). |
| 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. |
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 this 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 populates the following Case fields by mapping information from the Inbox Item:
- Source Literature Review
- Source Literature Article
- Source Document
- Number of Cases
The newly created Cases are linked to 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.