Enable Importing Literature References from Databases

With the 23R3 release, SafetyDocs supports importing literature references in bulk from third-party databases, allowing users to upload a file from a database into their Vault Library and then associate a Literature Search Term with it. Users can select an action to import articles from the file, directing Vault to create Literature Articles and map all of the file’s information to them.

Updates

We have added the following updates to this feature:

• IMIC Literature Intake: With the 26R2 release, SafetyDocs introduces the ability to import literature references from International Medical Information Center (IMIC)-formatted TXT files directly into Literature Articles, allowing for further processing and creation of Inbox Items. See Configure IMIC Literature Intake to configure your Vault for this feature.
• Highlight Literature Abstract Terms: With the 25R1 release, SafetyDocs has replaced the Abstract (English) section on the Literature Article object with an updated Abstract control section. This control section contains a drop-down that enables the user to toggle the Abstract text between English and its original language, eliminating the need for a separate English language field. To update your Vault to support this functionality, you must update the Literature Article object layout.
• EMA MLM RIS Literature File Support: With the 25R1 release, Vault supports importing literature references from European Medicines Agency Medical Literature Monitoring (EMA MLM) RIS files. Configure this feature by adding new fields to your Literature Article and Product Family object layouts.

Prerequisite

Before enabling this feature in your Vault, you must enable Literature Review Process Management.

Overview

To enable this feature in your Vault:

• Create a Literature Database for each database from which you want to import content
• Configure object layouts
• Update the General field layout
• Create the Import Articles from File action on the Literature Search Term object
• Configure object lifecycles
• Configure the Literature Document Lifecycle
• Configure security
• Configure custom sharing rules on the Literature Author object

Create Literature Database Records

To support importing literature references from database files, you must create a Literature Database record for each database from which you want to import content (for example, PubMed, Scopus, or Embase).

To create a Literature Database record:

1. Navigate to Business Admin > Literature Databases.
2. Select Create.
3. Enter a Name to indicate the literature database to which you are connecting.
4. Select Save.

Configure Object Layouts

To support importing literature references from database files, configure the following object layouts:

• Literature Article layout
• Literature Search Term layout
• Literature Author layout
• Literature Additional Information layout

Literature Article Layout

1. Navigate to Objects > Literature Article > Layouts > Literature Article Detail Page Layout.
2. Add the following fields to the Reference Information section:
   • DOI
   • Reference Type
   • Abbreviated Title of Journal
   • Date of Publication
   • Database Name
   • Database Provider
   • Publisher
   • Accession Number
   • Title (English)
   • Call Number
   • ISBN/ISSN
   • Volume
   • Issue Number
   • Section
   • Edition
   • Start Page
   • End Page
   • Reference ID

Insert the Literature Author Section

1. On the Literature Article Detail Page Layout, select Insert Section and then select Related Object from the picklist.
2. In the Add Related Object Section dialog, select Literature Author as the related object and select the Create record in pop-up dialog option.
3. In the Literature Author section, select Edit Columns and ensure the following columns are added:
   • Author Type
   • First Name
   • Last Name

Insert the Vancouver Citation Section

1. On the Literature Article Detail Page Layout, select Insert Section and then select Text from the picklist.
2. In the Add Text Section dialog, complete the fields as follows and then select Done:
   • Section Label: Enter "Vancouver Citation"
   • Section Name: Enter "vancouver_citation"
   • Long Text / Rich Text Field: Select Vancouver Citation

Insert the Literature Additional Info Section

1. On the Literature Article Detail Page Layout, select Insert Section and then select Related Object from the picklist.
2. In the Add Related Object Section dialog, select Literature Additional Info as the related object and select the Prevent record creation option.
3. In the Additional Info section, select Edit Default Columns and ensure the following columns are added:
   • Tag
   • Value

Literature Search Term Layout

1. Navigate to Objects > Literature Search Term > Layouts > Literature Search Term Detail Page Layout.
2. Select Insert Section and then select Related Documents from the picklist.
3. In the Add Related Document Section dialog, edit the fields as needed and then select Done.
4. In the Documents section, select Edit Columns and ensure the following columns are added:
   • Document Number
   • Type
   • Subtype
   • Classification
   • Status

Literature Author Layout

1. Navigate to Objects > Literature Author > Layouts > Literature Author Detail Page Layout.
2. Add the following fields to the Details section:
   • Author Type
   • First Name
   • Last Name
   • Value

Literature Additional Information Layout

1. Navigate to Objects > Literature Additional Information > Layouts > Literature Additional Information Detail Page Layout.
2. Add the following fields to the Details section:
   • Literature Article
   • Tag
   • Value

Update Field Layout

Complete the following steps to move the Literature Search Term field next to other related fields.

1. Navigate to Admin > Configuration > Field Layout > General (general_c).
2. Select Edit.
3. Drag and drop the fields to group together the following:
   • Literature Review (Literature)
   • Literature Article (Literature › Literature Article)
   • Literature Search Term (Literature › Review Document › Database Export)
4. Save the page.

Create Object Action

Complete the following steps to add the Import Articles from File action on the Literature Search Term object:

1. Navigate to Admin > Configuration > Objects > Literature Search Term.
2. On the Actions tab, select Create.
3. In the Create Action window, select Import Articles From File and then select Continue.
4. Make any required changes to the action and then save the page.

Configure Object Lifecycles

Complete the following steps to set up the object lifecycles related to this feature.

Configure Settings on the Literature Search Term Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Literature Search Term Lifecycle and complete the following steps:

1. Add Roles

In the Roles section, add the following roles:

• Aggregate Report Writer
• Reviewer

2. Update Role Permissions

In the Roles section, select Edit to update the role permissions as follows:

Role	Permissions
Aggregate Report Writer	All states: Read
Editor	All states: Read
Owner	All states: Read
Reviewer	Error, Active, Importing: Read Active, Imported: Read, Edit
Viewer	All states: Read

3. Add a User Action to the Active State

1. In the States section, select Active.
2. In the User Actions section, select Edit.
3. Select Create Rule and configure the following rule:
   • Always > Import Articles From File
   • Action Label: Import Articles from File

Configure Settings on the Literature Author Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Literature Author Lifecycle and complete the following steps:

1. Add Roles

In the Roles section, add the following roles:

• Aggregate Report Writer
• Reviewer

2. Update Role Permissions

In the Roles section, select Edit to update the role permissions as follows:

Role	Permissions
Aggregate Report Writer	All states: Read
Editor	All states: Read, Edit, Delete
Owner	All states: Read, Edit, Delete
Reviewer	Inactive: Read Active: Read, Edit
Viewer	All states: Read

Configure Settings on the Literature Additional Info Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Literature Additional Info Lifecycle and complete the following steps:

1. Add Roles

In the Roles section, add the following roles:

• Aggregate Report Writer
• Reviewer

2. Update Role Permissions

In the Roles section, select Edit to update the role permissions as follows:

Role	Permissions
Aggregate Report Writer	All states: Read
Editor	All states: Read, Edit, Delete
Owner	All states: Read, Edit, Delete
Reviewer	All states: Read
Viewer	All states: Read

Configure Document Lifecycle

Complete the following steps to set up the document lifecycle related to this feature.

Configure Settings on the Literature Document Lifecycle

Go to Admin > Configuration > Document Lifecycles > Literature Document Lifecycle and complete the following steps.

1. Add Role

1. On the Roles tab, select Create.
2. On the Create Lifecycle Role page, complete the fields as follows:
   • Label: Enter "Aggregate Report Writer"
   • Application Role: Select Aggregate Report Writer
3. Save the page.

2. Add Security Settings to the New State

1. On the States tab, select New.
2. Go to Security Settings and select Edit.
3. Configure the settings as follows:
   

3. Add Security Settings to the Importing State

1. On the States tab, select Importing.
2. Go to Security Settings and select Edit.
3. Configure the settings as follows:
   

4. Add Security Settings to the Error State

1. On the States tab, select Error.
2. Go to Security Settings and select Edit.
3. Configure the settings as follows:
   

Configure Security

Add security settings to grant access to this feature. Use the following settings as a starting point, but configure access according to your business processes.

Add the Literature Actions Permission Set

1. Go to Admin > Users & Groups > Permission Sets.
2. Select Create.
3. In the Name field, enter "Literature Actions".
4. Save the page.

Grant Object Permissions

Once the above Permission Set has been created, complete the following steps to ensure your permissions sets are granted the appropriate level of access to objects needed for this feature.

1. On the Signal Management permission set, navigate to the Objects tab and select Edit.
2. Grant Read permissions on the Literature Additional Information object.
3. Grant Read, Create, Edit, Delete permissions on the Literature Author object.
4. Save the page.

Configure Custom Sharing Rules on the Literature Author Object

Complete the steps below to configure Custom Sharing Rules on the Literature Author object:

1. Navigate to Admin > Configuration > Objects > Literature Author.
2. On the Details tab, select Edit and then select the Enable Custom Sharing Rules checkbox.
3. When prompted, select Continue and save the page.
4. In the Sharing Rules tab, select Create.
5. In the Label field, enter "Literature Author - Reviewer" and save the page.
6. In the Roles section on the new custom rule page, select Add.
7. Add the following roles, with Literature Users in the Users & Groups field:
   • Editor
   • Reviewer

(26R2) Configure IMIC Literature Intake

To allow users to import literature references from IMIC TXT files:

• Add the following fields to the Reference Information section of the Literature Article object layout:
  • Publication Date
  • Article Type
  • Information Type
  • Program
  • DR Details
  • Conference Date
  • Dispatch Date
  • Original Article
  • References
  • Subtitle
• If you are using a custom object layout for the Literature Standard Search Term object, update its layout rules:
  • Update the JAPIC layout rule as follows:
    • Label: Enter JAPIC/IMIC
    • IF this Layout Rule Expression is TRUE: Enter search_database__vr.name__v = 'JAPIC' || search_database__vr.name__v = 'IMIC'
  • Update the Non-JAPIC layout rule as follows:
    • Label: Enter Non-JAPIC/IMIC
    • IF this Layout Rule Expression is TRUE: Enter search_database__vr.name__v != 'JAPIC' && search_database__vr.name__v != 'IMIC'
• To allow your users to create Inbox Items from Literature Articles imported from IMIC files:
  • Your Vault must be licensed for both Veeva Safety and Veeva SafetyDocs. Contact your Veeva Representative for more information.
  • You must enable Creation of Inbox Items from Literature Articles.

(25R1) Configure EMA MLM RIS Literature File Support

To configure EMA MLM RIS Literature File Support, add the specified fields to the following object layouts:

• Literature Article
• Product Family

Update the Literature Article Layout

To update the Literature Article object layout:

1. Navigate to Admin > Configuration > Objects > Literature Article > Layouts > Literature Article Detail Page Layout.
2. Add the following fields:
   • ICSR Review Outcome: Add this field to the Review Outcome section under the Number of Identified Cases field
   • EMA Inclusion/Exclusion Criteria: Add this field to the Reference Information section under the Database Provider field

Update the Product Family Layout

To update the Product Family object layout:

1. Navigate to Admin > Configuration > Objects > Product Family > Layouts > Product Family Detail Page Layout.
2. Add the EMA Substance Group field.