Enable Literature Review Process Management

Learn how to configure your Vault to support compliance through faster literature screening and management.

About the Feature

Vault SafetyDocs now supports management of literature articles and article reviews for a more transparent process around Individual Case Safety Report (ICSR) detection and signal identification. With this feature, you can store documents in a centralized location. Decisions around relevancy can be documented and immediate action can be taken, when applicable.

Support for literature management was added in 23R1, which includes the necessary configuration by default. Vaults deployed prior to 23R1 must have the configuration upgrades described on this page to enable this feature.

See Manage the Literature Review Process for more information.

Configure the Literature Database Records Layout

Complete the following steps to configure the Literature Database Records layout.

1. In Admin, go to Configuration > Objects > Literature Database > Layouts.
2. Configure the Literature Database Detail Page Layout as shown below.
3. Select Save.

Configure Security

You will need to add security settings to grant access to the literature management features. Use the following settings as a starting point, but configure access according to your business process.

Add the Literature Actions Permission Set

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

Grant Permissions

Ensure your Permissions Sets are granted the appropriate level of access to applications, objects, and tabs according to your organization’s process.

1. In Admin, go to Users & Groups > Permission Sets > Literature Actions.
2. Under Objects, select Edit.
3. Grant permissions on the objects as follows:

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

4. Under Tabs, select Edit.
5. Grant View permissions on the following tabs:
   • Home
   • Library
   • Reports
   • Dashboards
   • Literature Reviews
   • Literature Articles

Add the Literature Security Profile

1. In Admin, go to Users & Groups > Security Profiles.
2. Select Create.
3. In the Name field, enter "Literature".
4. In the Permission Sets field, select the Literature Actions permission set configured previously.
5. Select Save.

Configure Object Lifecycles

Object Lifecycles are managed through Admin > Configuration > Object Lifecycles > [Lifecycle].

Configure the Literature Article Lifecycle

Complete the following steps to configure this lifecycle:

Add Roles to the Literature Article Lifecycle

1. In Admin, go to Configuration > Object Lifecycles > Literature Article Lifecycle.
2. In the Roles section, complete the following actions:
   • Add the Reviewer role.
   • Add the Aggregate Report Writer role.

Enable Custom Sharing Rules for the Literature Article Object

1. In Admin, go to Configuration > Objects > Literature Article.
2. Select Edit and then select the Enable Custom Sharing Rules checkbox.
3. Configure the following custom rule:
   

Update Role Permissions for the Literature Article Object

1. In Admin, go to Configuration > Object Lifecycles > Literature Article Lifecycle.
2. In the Roles section, update the following role permissions:
   

Configure the Literature Article Lifecycle Stage Group:

1. In Admin, go to Configuration > Lifecycle Stage Groups.
2. Select Create and then select Object Stage Group.
3. Configure the Literature Article stages as shown below:
   

Configure the Literature Review Lifecycle

Complete the following steps to configure this lifecycle:

Add Roles to the Literature Review Lifecycle

1. In Admin, go to Configuration > Object Lifecycles > Literature Review Lifecycle.
2. In the Roles section, complete the following actions:
   • Add the Reviewer role.
   • Add the Aggregate Report Writer role.

Enable Custom Sharing Rules for the Literature Review Object

1. In Admin, go to Configuration > Objects > Literature Review.
2. Select Edit and then select the Enable Custom Sharing Rules checkbox.
3. Configure the following custom rule:
   

Update Role Permissions for the Literature Review Object

1. In Admin, go to Configuration > Object Lifecycles > Literature Review Lifecycle.
2. In the Roles section, update the following role permissions:
   

Apply Atomic Security for the Literature Review Object

1. In Admin, go to Configuration > Object Lifecycles > Literature Review Lifecycle.
2. In the States section, select the Complete state. The Complete state page appears.
3. In the Atomic Security: Relationships section, create the following records to apply atomic security for relationships with the Literature Articles and Literature Search Terms objects:
   

Configure the Literature Review Lifecycle Stage Group

1. In Admin, go to Configuration > Lifecycle Stage Groups.
2. Select Create and then select Object Stage Group.
3. Configure the Literature Review stages as shown below:
   

Configure the Literature Search Term Lifecycle

Complete the following steps to configure this lifecycle:

Add Roles to the Literature Search Term Lifecycle

1. In Admin, go to Configuration > Object Lifecycles > Literature Search Term Lifecycle.
2. In the Roles section, complete the following actions:
   • Add the Reviewer role.
   • Add the Aggregate Report Writer role.

Enable Custom Sharing Rules for the Literature Search Term Object

1. In Admin, go to Configuration > Objects > Literature Search Term.
2. Select Edit and then select the Enable Custom Sharing Rules checkbox.
3. Configure the following custom rule:
   

Update Role Permissions for the Literature Search Term Object

1. In Admin, go to Configuration > Object Lifecycles > Literature Search Term Lifecycle.
2. In the Roles section, update the following role permissions:
   

Configure Document Lifecycles

Document Lifecycles are managed through Admin > Configuration > Document Lifecycles > [Lifecycle].

Configure the Literature Document Lifecycle

Complete the following steps to configure this lifecycle:

Update the Editor and Reviewer roles to add Literature Group

1. In Admin, go to Configuration > Document Lifecycles > Literature Document Lifecycle > Roles.
2. For the Editor and Reviewer roles, go to Default Rule.
3. Select Edit and then select Add.
4. From the dropdown menu, select the Literature group that was previously configured.
5. Select the Default User checkbox.
6. Select Save.

Update the Security Settings in the Imported State

1. In Admin, go to Configuration > Document Lifecycles > Literature Document Lifecycle > States.
2. From the Imported state, go to Security Settings.
3. Configure the following security settings:
   

Create a User Action in the Imported State

1. From the Imported state, go to User Actions.
2. Select Edit and then select Create Rule.
3. Create the following rule:
   

Update the Security Settings in the Review Complete State

1. From the Review Complete state, go to Security Settings.
2. Configure the following security settings:
   

Create an Entry Action in the Review Complete State

1. From the Review Complete state, go to Entry Actions.
2. Select Edit and then select Complete Entry Action.
3. Create the following action:
   

Configure Workflows

Ensure your Object Workflows are set up according to your organization’s process. See About Object Workflows for more information.

Create the Literature Review Workflow

Complete the following steps to set up a workflow to manage literature reviews:

1. In Admin, go to Configuration > Workflows.
2. Select Create and then select Object Workflow.
3. In the Label field, enter "Literature Review Workflow."
4. In the Lifecycle field, select Literature Review Lifecycle.
5. Configure the workflow as shown below:
   

Add Configurations to the Literature Review Lifecycle

1. On the Literature Review Workflow Details page, select Literature Review Lifecycle.
2. In the States section, select each of the following states and complete their respective configurations:

   State	Configuration
   New	Configure a User Action to always change the state to Pending Review for records that are related by Literature Articles.
   In Review	Configure an Entry Action to always start Article Review.
   Complete	Configure the Entry Criteria to always validate that the Literature Articles object has no records that are in the Pending Review, New, or In Review states.

Create the Literature Article Review Workflow

Complete the following steps to set up a workflow to manage the review and approval process for literature articles.

1. In Admin, go to Configuration > Workflows.
2. Select Create and then select Object Workflow.
3. In the Label field, enter "Literature Article Review Workflow."
4. In the Lifecycle field, select Literature Article Lifecycle.
5. When creating the Start step of the workflow, configure 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 the Allow workflow initiator to select participants option. Select the Default Users from sharing settings checkbox.
   Control 3: Date	In the Label field, enter "Due Date."

6. Configure the workflow as shown below:
   

Add a User Action to the Pending Review State

1. On the Literature Article Review Workflow Details page, select Literature Article Lifecycle.
2. In the States section, select the Pending Review state.
3. In this state, configure a User Action to always start Article Review.

Manage Tabs

For easy user access to literature processing features, configure the following tab settings in your Vault.

Activate Literature Tabs

1. In Admin, go to Configuration > Tabs.
2. For the following tabs, select Edit and set Status: Active
   • Literature
   • Literature Reviews
   • Literature Articles

Create a Literature Monitoring Tab Collection

1. In Admin, go to Configuration > Tab Collections.
2. Select Create.
3. In the Label field, enter "Literature Monitoring".
4. In the Status field, select Active.
5. On the right-hand side, select Add Tabs and then add the following tabs to your collection:
   • Home
   • Literature
   • Cases
   • Analytics
   • Library