Enable Literature Review Process Management

With the 23R1 release, SafetyDocs supports the management of literature articles and article reviews for a faster, more transparent literature screening process around Individual Case Safety Report (ICSR) detection and signal identification. This feature allows you to store documents and document and action relevancy decisions in one centralized location.

25R2 Updates

With the 25R2 release, SafetyDocs introduces the following new features:

• Literature Article QC Sampling: With the 25R2 release, SafetyDocs supports randomized QC sampling for your Literature Articles, helping you ensure data quality. This feature routes Literature Articles with a randomly assigned QC Sampling Number value above a specified threshold through an additional QC step in the existing Literature Article Review workflow. To configure your Vault for this feature, see Configure Literature Article QC Sampling.
• Literature Inclusion in Aggregate Reports: With the 25R2 release, SafetyDocs extends aggregate reporting functionality by allowing users to mark specific Literature Articles and Literature Article Products for inclusion in aggregate reports. To configure your Vault for this feature, see Enable Literature Inclusion in Aggregate Reports.

25R1 Update: Highlight Literature Abstract Terms

With the 25R1 release, SafetyDocs introduces Highlight Literature Abstract Terms, streamlining the identification of ICSRs and emerging safety signals by automatically highlighting relevant terms in the Abstract field of your Literature Article records. This functionality allows your users to quickly review abstracts in order to determine whether a full-text review is necessary. You can configure your Vault to highlight the terms that matter for your organization’s specific patient, seriousness, and company-specific term needs. See Configure Highlight Literature Abstract Terms to configure your Vault for the updated feature.

After you have enabled this feature, learn how to manage Literature Highlighted Terms.

Overview

To configure this feature in your Vault:

• Configure the Literature Database object layout
• Configure security
• Configure custom sharing rules
• Configure object lifecycles
• Configure the Literature Document Lifecycle
• Configure workflows
• Update object lifecycles to support workflows
• Configure tabs

Configure the Literature Database Object Layout

To configure the Literature Database object layout:

1. Navigate to Admin > Configuration > Objects > Literature Database > Layouts > Literature Database Detail Page Layout.
2. Select Edit.
3. Configure the layout as follows:
   • Ensure the Details section contains the Name field
   • Ensure the System section contains the following fields in the following order:
     • Created By
     • Created Date
     • Last Modified By
     • Last Modified Date
4. Select Save.

Configure Security

Configure security to grant access to the literature management features. Use the following settings as a starting point, but configure access according to your business process:

• Create a Literature Actions permission set
• Create a Literature security profile and add to it the Literature Actions permission set
• Grant permissions on the Literature Actions permission set

Grant Literature Actions Permissions

To grant permissions to the Literature Actions permission set:

1. Grant View tab permissions to the following tabs:
   • Home
   • Library
   • Reports
   • Dashboards
   • Literature Reviews
   • Literature Articles
2. Grant object permissions as follows:

Permissions	Objects
Read	Literature Article Literature Review Literature Database Literature Search Term Object Stage Label Document Stage Label Product Product Registration Substance Study Study Registration Workflow
Create	Literature Article Literature Review Literature Database Literature Search Term
Edit	Literature Article Literature Review Literature Database Literature Search Term
Delete	Literature Article Literature Review Literature Database Literature Search Term

Configure Custom Sharing Rules

Configure custom sharing rules for the following objects:

• Literature Article
• Literature Review
• Literature Search Term

To configure custom sharing rules for an object:

1. Enable custom sharing rules.
2. Create a custom sharing rule with the following settings:
   • Label: Enter [Object] - Reviewer, where [Object] is the object for which you are creating the sharing rule
   • In the Roles section, add the following roles for the Literature group:
     • Reviewer
     • Editor

Configure Object Lifecycles

Configure the following object lifecycles:

• Literature Article Lifecycle
• Literature Review Lifecycle
• Literature Search Term Lifecycle

Configure the Literature Article Lifecycle

To configure the Literature Article Lifecycle:

• Add the Reviewer and Aggregate Report Writer roles
• Edit role permissions
• Configure the Literature Article object lifecycle stage group

Edit Literature Article Lifecycle Role Permissions

Edit role permissions on the Literature Article Lifecycle as follows:

Role	Lifecycle State	Permissions
Aggregate Report Writer	All lifecycle states	Read
Editor	Pending Review	Read Edit
	Further Action In-Progress	Read Edit
	Complete	Read
	New	Read Edit Delete
	Inactive	Read Edit
	In Review	Read Edit
Owner	All lifecycle states	Read
Reviewer	Pending Review	Read Edit
	Further Action In-Progress	Read Edit
	Complete	Read
	New	Read Edit Delete
	Inactive	Read
	In Review	Read Edit
Viewer	All lifecycle states	Read

Configure the Literature Article Lifecycle Stage Group

Create an object lifecycle stage group with the following settings:

• Stage Group Label: Enter Literature Article
• Object Lifecycle: Select Literature Article Lifecycle
• Object Type: Select Base Literature Article

Then, create stages and define their states as follows:

• Create the New stage, then add the following states:
  • New
  • Pending Review
• Create the In Progress stage, then add the following states:
  • In Review
  • Further Action In-Progress
• Create the Complete stage, then add the Complete state

Configure the Literature Review Lifecycle

To configure the Literature Review Lifecycle:

• Add the Reviewer and Aggregate Report Writer roles
• Edit role permissions
• Configure atomic security on relationships for the Complete lifecycle state
• Configure the Literature Review object lifecycle stage group

Edit Role Permissions for the Literature Review Object

Edit role permissions on the Literature Review Lifecycle as follows:

Role	Lifecycle State	Permissions
Aggregate Report Writer	All lifecycle states	Read
Editor	Complete	Read
	Inactive	Read
	Searching	Read Edit
	In Review	Read Edit
	New	Read Edit Delete
Owner	All lifecycle states	Read
Reviewer	Complete	Read
	Inactive	Read
	Searching	Read Edit
	In Review	Read Edit
	New	Read Edit Delete
Viewer	All lifecycle states	Read

Configure Atomic Security on Relationships for the Complete State

To configure atomic security on relationships for the Complete state of the Literature Review Lifecycle, apply the Read state behavior to the following relationships:

• Literature Articles
• Literature Search Terms

Configure the Literature Review Lifecycle Stage Group

Create an object lifecycle stage group with the following settings:

• Stage Group Label: Enter Literature Review Stages
• Object Lifecycle: Select Literature Review Lifecycle
• Object Type: Select Base Literature Review

Then, create stages and define their states as follows:

• Create the New stage, then add the New state
• Create the In Progress stage, then add the following states:
  • Searching
  • In Review
• Create the Complete stage, then add the Complete state

Configure the Literature Search Term Lifecycle

To configure the Literature Search Term Lifecycle:

• Add the Reviewer and Aggregate Report Writer roles
• Edit role permissions as follows:

Role	Lifecycle State	Permissions
Aggregate Report Writer	All lifecycle states	Read
Editor	Inactive	Read Edit
	Active	Read Edit Delete
Owner	All lifecycle states	Read Edit Delete
Reviewer	Inactive	Read
	Active	Read Edit
Viewer	All lifecycle states	Read

Configure the Literature Document Lifecycle

To configure the Literature Document Lifecycle:

• Define allowed and default users for the Editor and Reviewer roles
• Update lifecycle state security settings
• Create actions

Define Allowed and Default Users for the Editor and Reviewer Roles

To define allowed and default users for the Editor and Reviewer roles, add the Literature group, then select the Default User checkbox.

Update Lifecycle State Security Settings

Update document lifecycle state security settings for the following states on the Literature Document Lifecycle:

• Imported
• Review Complete

Update Imported State Security Settings

Update lifecycle state security settings on the Imported state as follows:

Role	Security Settings
Owner	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Create Anchors Download Source Edit Document Manage Viewable Rendition Reclassify
Coordinator	No permissions
Editor	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Create Anchors Download Source Edit Document
Viewer	View Document View Content
Consumer	No permissions
Reviewer	View Document View Content Edit Fields Edit Relationships Annotate Download Source Edit Document
Approver	View Document View Content Edit Fields Edit Relationships Annotate Download Source Edit Document
Aggregate Report Writer	View Document View Content

Update Review Complete State Security Settings

Update lifecycle state security settings on the Review Complete state as follows:

Role	Security Settings
Owner	View Document View Content Edit Sharing Settings Version Download Source
Coordinator	View Document View Content Download Source
Editor	View Document View Content Edit Sharing Settings Version Download Source
Viewer	View Document View Content Download Source
Consumer	View Document View Content
Reviewer	View Document View Content Edit Sharing Settings Version Download Source
Approver	View Document View Content Download Source
Aggregate Report Writer	View Document View Content Download Source

Create Actions

Create a user action on the Imported state of the Literature Document Lifecycle with the following settings:

• Condition Type: Select Always
• Allow the following actions:
  • Select Change State to
  • Select Review Complete
  • Action Label: Enter Complete Review

Create an entry action on the Review Complete state of the Literature Document Lifecycle with the following settings:

• Condition Type: Select Always
• perform actions: Select Set new major version

Configure Workflows

Use the following object workflows as a starting point, but configure your workflows according to your business processes:

• Literature Review Workflow
• Literature Article Review Workflow

Create the Literature Review Workflow

Create the following workflow to manage literature reviews:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter Literature Review Workflow
   • Lifecycle: Select Literature Review Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start Start step
   • SC: Searching state change action step
   • Task: Search for Articles task step
   • Decision: Go to Review decision step
   • SC: Complete (no articles) state change action step
   • SC: In Review state change action step
   • Task: Coordinate Reviews task step
   • SC: Complete state change action step
   • End end step

Create the Literature Article Review Workflow

Create the following workflow to manage the review and approval process for literature articles:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter Literature Article Review Workflow
   • Lifecycle: Select Literature Article Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:

   • Start Start step with the following controls:

     Control	Description
     Control 1: Instructions	Instruct users to specify the review team for each article
     Control 2: Participants	In the Participant Label field, enter Reviewer(s) Select Allow workflow initiator to select participants Select the Default Users from sharing settings checkbox
     Control 3: Date	In the Label field, enter Due Date

   • SC: In Review state change action step
   • Task: Review Article task step
   • Decision: Next Steps decision step
   • SC: Complete (no action) state change action step
   • Action: Set ICSRs action step
   • Task: Coordinate All Actions task step
   • Action: Set Investigation action step
   • Action: Set All Fields action step
   • End end step

Update Object Lifecycles to Support Workflows

To update the Literature Article Lifecycle to support the Literature Article Review Workflow, create a user action on the Pending Review state to always start Article Review.

To update the Literature Review Lifecycle object lifecycle to support the Literature Review Workflow, create the following:

Lifecycle State	Type	Configuration
New	Entry action	Always start Article Review
In Review	Entry action	Always change the state to Pending Review for records that are related by Literature Articles
Complete	Entry criteria	Always validate that the Literature Article object has no records that are in the Pending Review, New, or In Review states

Configure Tabs

For easy user access to literature processing features:

• Set the tab status to Active for the following tabs:
  • Literature
  • Literature Reviews
  • Literature Articles
• Create an active Literature Monitoring tab collection and add the following tabs:
  • Home
  • Literature
  • Cases
  • Analytics
  • Library

(25R2) Configure Literature Article QC Sampling

To configure Literature Article QC Sampling, you must configure the Literature Article Review workflow:

1. Navigate to Admin > Configuration > Workflows > Literature Article Review.
2. Select Edit.
3. Configure the following:
   • QC decision step
   • QC Review task step
   • QC Success decision step
   • A user action on the Literature Article Lifecycle

Configure the QC Decision Step

To configure the decision step that routes a sampling of Literature Articles through QC review:

1. In the Workflow Steps section, under the Task: Review Article step, select Create Step.
2. In the Label field, enter Decision: QC?, then select Save.
3. In the Type drop-down, select Decision.
4. In the Rules section, select Create Rule and complete the fields as follows:
   • Condition Type: Select All conditions are met
   • If > Task > Task: Review Article > all labels equal > No Action Needed
   • Select Add condition
   • If > Field > QC Sampling Number > is greater than > 90^Note
   • then: Select Create Step
   • In the Step Name field, enter Task: QC, then select OK
5. Select Create Rule and complete the fields as follows:
   • Condition Type: Select All conditions are met
   • If > Task > Task: Review Article > no labels equal > No Action Needed
   • Select Add condition
   • If > Field > QC Sampling Number > is greater than > 95^Note
   • then: Select Task: QC
6. In the Else rule, in the then drop-down, select Decision: Next Steps.
7. Select Save.
8. Navigate back to the main page of the workflow.

Configure the QC Review Task Step

To configure the QC Review task step:

1. In the Workflow Steps section, select Task: QC, then select Edit.
2. In the Type drop-down, select Task.
3. In the Next Steps drop-down:
   • Select Create Step
   • In the Step Name field, enter Decision: Successful QC?
   • Select OK
4. In the Task Options section, complete the fields as follows:
   • Task Label: Enter Literature Article QC Review
   • Assign Task To: Select Workflow Owner
   • Instructions: Enter Please QC the results of the previous task.
   • Task Requirement: Select Required
   • Display information about previous tasks: Select Task: Review Article
   • Due Date: Select Task Creation Date > + then enter 2 in the Days field
   • Prompts: Select Prompt for Verdicts
     • In the Verdict Label field, enter No quality concerns, continue
     • Select Add Verdict
     • In the new verdict’s Verdict Label field, enter Quality concerns, send back to article review
     • Select Add Comments
     • In the Prompt for Comments field, enter Please explain your decision and then select Required
   • Notification Template: Select ObjectTaskReminderNotification
5. Select Save.
6. Navigate back to the main page of the workflow.

Configure the QC Success Decision Step

To configure the decision step that routes Literature Articles that failed their QC check back through the review process:

1. In the Workflow Steps section, select Decision: Successful QC?, then select Edit.
2. In the Type drop-down, select Decision.
3. In the Rules section, select Create Rule and complete the fields as follows:
   • Condition Type: Select All conditions are met
   • If > Task > Task: QC > at least one label equals > Quality concerns, send back to article review
   • then: Select Task: Review Article
4. In the Else rule, select Decision: Next Steps in the then drop-down.
5. Select Save.
6. Navigate back to the main page of the workflow.

Configure a User Action on the Literature Article Lifecycle

To configure the user action that initiates the Literature Article Review workflow:

1. To navigate to the lifecycle, from the Lifecycle field, select Literature Article Lifecycle.
2. On the Literature Article Lifecycle page, under the States section, select New.
3. On the New lifecycle state page, next to User Actions, select Edit.
4. Select Create Rule and complete the fields as follows:
   • Condition Type: Select Always
   • perform actions: Select Workflow > Literature Article Review
   • Action Label: Enter an appropriate label
5. Select Save.

(25R1) Configure Highlight Literature Abstract Terms

To configure Highlight Literature Abstract Terms, you need to:

• Update Load Terms for Abstract Highlighting settings
• Update the Literature Highlighted Term object layout
• Update the Literature Article object layout
• Grant Literature Highlighted Term object permissions

Update Load Terms for Abstract Highlighting Settings

To turn on this feature in your Vault:

1. Navigate to Admin > Settings > SafetyDocs Settings.
2. Select Edit.
3. Select the Load Terms for Abstract Highlighting checkbox.
4. Select Save.

Update the Literature Highlighted Term Object Layout

To update the Literature Highlighted Term object layout:

1. Navigate to Admin > Configuration > Objects > Literature Highlighted Term > Layouts.
2. Next to the standard layout, select the Actions menu and then select Save As.
3. Review the information in the Save As dialog and select Done.
4. Select Save to return to the Literature Highlighted Term > Layouts page.
5. Next to the newly created layout, select the Actions menu and then select Set As Default.
6. Next to the old custom layout, select the Actions menu and then select Delete > Continue.

Update the Literature Article Object Layout

To update the Literature Article object layout:

1. Navigate to Admin > Configuration > Objects > Literature Article > Layouts.
2. Next to the standard layout, select the Actions menu and then select Save As.
3. Review the information in the Save As dialog and select Done.
4. Select Save to return to the Literature Article > Layouts page.
5. Next to the newly created layout, select the Actions menu and then select Set As Default.
6. Next to the old custom layout, select the Actions menu and then select Delete > Continue.

Grant Literature Highlighted Term Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to the Literature Highlighted Term object according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > Literature Actions > Objects > Literature Highlighted Term.

We recommend granting the following Literature Highlighted Term object permissions:

• Read
• Create
• Edit
• Delete