Configuring Global Content Plans (RIM)

Global Content Plans are packages of global or core documents for initial submissions or dossier changes, which are distributed from central teams to local affiliates to use as the basis for local submissions to their respective country’s health authority.

In Vault RIM, global content planning expedites core document assembly for local submission by joining event and activity management and local dispositioning with Submissions and content planning.

Configuration Overview

To set up global content plans, complete the following steps:

1. Configure the Global Application and Global Submission object types and update other Application and Submission object types to support global content planning.
2. Add the Event Source field to Submission relationship objects and page layouts.
3. Configure the Event object, object types, and their page layouts to include global content planning fields.
4. Review and configure new and existing object fields and page layouts.
5. Configure new workflows for creating and updating global content plans.
6. Update the Event object lifecycle with additional user actions and workflows.
7. Configure user permissions.
8. Create and update master data records.
9. Recommended: Enable the Delete Inactive Content Plans job to delete unused, inactive Content Plan and Content Plan Item records, reducing the number of unnecessary records which can cause performance issues in some Vaults. See RIM Submissions Overview for more information.
10. Recommended: Configure your Vault to dispatch global content plans in sections, allowing affiliate users to review and accept or reject the changes Vault will make to the market-specific content plan. See Configuring Content Plan Synchronization for details.
11. Recommended: Configure your Vault to dispatch documents only based on the template module. See Configuring Content Plan Synchronization for details.
12. Optional: Configure your Vault to validate Activity and Submission lifecycle states during dispatch. See Configuring Content Plan Synchronization for details.
13. Optional: Configure Vault to generate Active Dossier records from a Global Content Plan dispatch.

Configuring Document Sets

Using the Document Set field, your organization can maintain one Global Content Plan that handles document variations for different groups of markets. See Using Global Content Plans for examples.

Your organization should consider the following when assessing the Document Set field and its functionality:

• The field is available for the Activity, Country, Application, and Content Plan Item objects and their object types, where applicable. This article includes steps to add the field to these page layouts.
• We recommend relabeling the default Document Set picklist values to fit your organization’s terminology.
• By default, Document Set is a single-select field, but can be configured to be multi-select for the available objects.
• We recommend enabling the application setting, Default Document Set on Activity to allow Vault to set the Document Set on newly-created Activity records based on the Related Application and Impacted Market field values. When enabled, Vault overrides any configured defaults and defaults on the Document Set field. See RIM Application Settings & Configuration Options.
• The Repeat on Document Set field can be used in conjunction with Document Set to automatically duplicate Content Plan Item records based on the Document Sets represented by the Event’s Activities. See Assessing the Repeat on Document Set Field.

Configuring Application & Submission Object Types

Application Object Types

To configure Application object types, complete the following:

1. Activate the Global Application (global_application__v) object type.
2. Create a new Global Application object page layout.
3. If not already configured, update the Lead Market (lead_market__rim) and Region (region__v) fields to be optional for the Application object by unchecking User must always enter a value (required). Then, update both fields to be required within each Application object type (except Global Application) by checking User must always enter a value (required).
4. Optional: If your organization plans to use Document Sets, add the Document Set (submission_grouping__v) field to the Application object types and their page layouts, except for Global Application. See Configuring Document Sets for more information and configuration options.
5. Optional: Review your Vault’s Applications and Submissions tab configurations. Consider excluding the Global Application and Global Submission types. You can create separate tabs for Global Application and Global Submission, if desired.

Submission Object Types

To configure Submission object types, complete the following:

1. Activate the Global Submission object type.
2. Create a new Global Submission object page layout.
3. Assess any additional fields to add to the Global Submission object type.

Additionally, if not already configured, Edit the Submission object Details panel and select Allow attachments. This configuration allows Vault to attach success and failure CSV files during dispatch.

Configuring the Event Source Field

To ensure Vault can set the field during content plan creation and update, add the Event Source (event_source__v) field to any Submission Product (submission_pharmaceutical_product__rim) object type and its page layout.

Additionally, add the field to the following Submission relationship object page layouts:

• Submission Active Substance
• Submission Inactive Ingredient
• Submission Indication
• Submission Clinical Study
• Submission Nonclinical Study
• Submission Pharmaceutical Form

Configuring the Event Object & Object Types

If not already configured, Edit the Event object Details panel and select Allow attachments. This configuration allows Vault to attach summary CSV files during dispatch.

Within the Event Object Types, review the available object types and determine which will support global content planning. Using this information, configure additional fields and object page layout updates per the below.

Object Type Fields

Add the below fields to all object types supporting global content planning:

• Global Application (global_application__v)
• Global Submission (global_submission__v)
• Global Content Plan (global_content_plan__v)
• Content Plan Template (content_plan_template__v)
• Initial Dispatch Date (initial_dispatch_date__v)
• Last Dispatch Date (last_dispatch_date__v)

Object Type Page Layouts

To configure object page layouts for each object type:

1. Add a new section (Global Content Plan Details) to contain the new fields added above.
2. Add the Use for Content Planning (use_for_content_planning__v) field to the Event Product, Event Inactive Ingredient, Event Active Substance, Event Clinical Study, Event Nonclinical Study, and Event Pharmaceutical Form sections.
3. Add the Event Indication (event_indication__v) field to the Event Clinical Study section.
4. Add the Event Product (event_pharmaceutical_product__v) field to the Event Inactive Ingredient section.
5. Add a new section for the Event Pharmaceutical Form relationship object (applicable to Switzerland).
6. Optional: If your organization plans to use document sets, update the layout to display the Document Set field within the Related Activities section. See Configuring Document Sets for more information and configuration options.

Configuring Additional Fields & Page Layouts

Add the indicated fields to the following object page layouts:

• Activity (activity__rim): If your organization plans to use document sets, add Document Set (submission_grouping__v). See Configuring Document Sets for more information and configuration options.
• Event Inactive Ingredient (event_inactive_ingredient__rim): Add Use for Content Planning (use_for_content_planning__v) and Event Product (event_pharmaceutical_product__v). Optionally, you can also remove the Product field in lieu of Event Product.
• Event Active Substance object types and page layouts: Add Use for Content Planning.
• Event Product object types and page layouts: Add Use for Content Planning.
• Event Clinical Study (event_clinical_study__v):
  • Add Use for Content Planning.
  • Add Event Indication (event_indication__v). Optionally, remove the Indication field in lieu of Event Indication.
  • Add Report Level Content Plan (report_level_content_plan__v).
• Event Nonclinical Study (event_nonclinical_study__v):
  • Add Use for Content Planning.
  • Add Report Level Content Plan (report_level_content_plan__v).
• Event Pharmaceutical Form (event_pharmaceutical_form__v): Add Use for Content Planning.
• Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v): Add Regulatory Objective Indication (regulatory_objective_indication__v). Optionally, you can also remove the Indication field.
• Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v): Add Regulatory Objective Product (regulatory_objective_product__v).
• Submission Pharmaceutical Form (submission_pharmaceutical_form__v): Add Event (event__v).

Additional Field Review & Configuration

Review and confirm or update your Vault’s object field configuration as follows:

1. Within the Application Country object, review the Country (country__rim) field. Remove any criteria VQL clause referencing the Region and Applicable Product Type fields, for example, “AND applicable_product_type__v = AND region__rim = ”.
2. Within the Submission Country object, ensure the Use for Content Planning field Default Value configuration is not set to “false”.
3. For the Content Plan Item object field Name, deselect Values must be unique to ensure repeated records are uniquely named.

Configuring Global Content Plan Workflows

You will need to create two new object workflows to create and update global content plans for the Event object lifecycle.

To do this, configure a Create Global Content Plan workflow and an Update Global Content Plan workflow with the below minimum requirements:

• For creating content plans, include a Prompt for Fields control at the start step to require the user to select a Global Application and Content Plan Template. Prompting for these fields on an Update Global Content Plan workflow is not recommended.
• Configure a System Action step to invoke the Create Global Content Plan system action. This action can be used for both creating and updating global content plans.

Configuring the Event Lifecycle

If your Vault doesn’t have an Event object lifecycle, you must create one and associate it with the Event object. Then, you can set up actions to allow users to create, update, and dispatch a related global content plan using the recommended workflows and system actions. See Managing Content Plans with a Lifecycle for more information.

To do this, configure the following workflow user actions within the Planned, In Progress, In Regulatory Assessment, and Regulatory Assessment Complete lifecycle states, except where indicated:

1. If Global Content Plan is blank, Create Global Content Plan in the Planned and In Progress states only. Additionally, select Display in All Actions menu.
2. If Global Content Plan is not blank, Update Global Content Plan. Additionally, select Display in All Actions menu.
3. If Global Content Plan is not blank, Dispatch Global Content Plan.

Additional Configuration Options

Ignore Content Plan Template Constraints

When selected, the Ignore Content Plan Template Constraints option allows Vault to ignore template constraints when copying the global content plan to local submissions.

When deselected, the template constraints from the target submission are applied when copying the global content plan during the dispatch process. In most Vaults, the option selected for the Copy Content Plan action should align with Dispatch Global Content Plan.

Copy Relationships

The Copy Relationships option allows Vault to copy relationships from the Event to the target submissions during dispatch. If users in your Vault do not create related Submission and Regulatory Objective records in bulk, you may consider selecting this option to expedite the creation process.

When selected, Vault compares existing Event relationships (for example, Event Indication) with existing Application and Submission relationships, then copies any missing relationship records to the target Application and Submission accordingly. For example, if the Application Indication relationship is missing, Vault adds an Application Indication and Submission Indication record to the target Application and target Submission, respectively. If the Application Indication relationship record exists, Vault adds a Submission Indication record and sets its Application Source field to the existing relationship record. When Event Clinical Study and Event Nonclinical Study relationships have an associated Report Level Content Plan (RLCP), the RLCP is copied to the relationships in the target Submission.

When deselected, Vault does not copy the relationships from the Event to the target submissions, resulting in only the content plan records that match the target submissions’ relationships to be copied. You may consider de-selecting this option if your organization encounters scenarios where only some Event relationships apply (for example, a Product Variant is applicable for the United States but not Canada) and users in your Vault create related Submission and Regulatory Objective records in bulk.

Enable Application Relationships

If your Vault has the Enable Application Relationships setting enabled, Vault leverages relationships from the Applications of the target submissions during dispatch.

When configured with the Copy Relationships option, Vault also checks for missing Application relationship records and copies them to the target Application and target Submission records accordingly. See Copy Relationships for more details.

Validate Matched Documents are Locked

When configured on the Dispatch Global Content Plan action, Validate Matched Documents are Locked prompts Vault to dispatch only when all of the in-scope documents are version-locked to the content plan. If one (1) or more documents are not version-locked, the dispatch fails and an error is displayed. Vault also validates document locking when regenerating a comparison that was generated with this option enabled. See Dispatching & Synchronizing Content Plans for more details.

Populate Active Dossier

When configured on the Dispatch Global Content Plan action, Populate Active Dossier prompts Vault to create Active Dossier records upon dispatch, based upon the selected Activities’ Local Dispositions.

This option must be configured for all Dispatch Global Content Plan user actions configured in the Event lifecycle as described in this article, as well as the Content Plan lifecycle. See Active Dossier Configuration for details.

Configuring User Permissions

The following permissions are required for users to work with global content plans:

Type	Permission Label	Controls
Security Profile	Object: Content Plan	Users must have at least Create access to create global content plans.
Security Profile	Object: Content Plan Item	Users must have at least Create access to create global content plans.
Security Profile	Object: Content Plan Template	Users must have at least Read access to create global content plans.
Security Profile	Object Type: Global Application	Users must have at least Read access to create global content plans.
Security Profile	Object Type: Global Submission	Users must have at least Read access to create global content plans.
Security Profile	Object: Event: Object Action Permissions	Users must have Execute access to the Global Content Plan action to view global content plans.
Security Profile	Object: Event: Object Action Permissions	Users must have Execute access to the Dispatch Global Content Plan action to perform the action.

Updating Master Data

Creating Controlled Vocabulary Records

You will need to create new Controlled Vocabulary records, one each for the Global Application and Global Submission types using the below information.

To do this:

1. Navigate to Admin > Business Admin and search the Components menu for Controlled Vocabularies.
2. Click Create.
3. Enter a Name (we recommend “Global Application”) and select Application Type for the Controlled Vocabulary Type. Enter Vault RIM UUID aa6585e1-15bb-43af-80c8-f838c5df048d.
4. Click Save.
5. Repeat the above steps for the Global Submission, where Name is the recommended “Global Submission”, Controlled Vocabulary Type is Submission Type, and Vault RIM UUID is 311354ce-a101-44e4-b88b-4ce65fd968b9.

Creating Constraint Records

You may optionally define a Constraint for global content plans by creating a record with the data below. This will allow Content Plan Template Constraints to be set up for the global content plan.

To do this:

1. Navigate to Admin > Business Admin and search the Components menu for Constraints.
2. Click Create. Select Application and Submission in the dialog, then click Continue.
3. For Applicable Product Type, select Drug and Medical Device.
4. For CV_1, locate the Controlled Vocabulary record you created for the Global Application. It will correspond to Vault RIM UUID aa6585e1-15bb-43af-80c8-f838c5df048d.
5. For CV_2, locate the Controlled Vocabulary record you created for the Global Submission. It will correspond to Vault RIM UUID 311354ce-a101-44e4-b88b-4ce65fd968b9.
6. Enter Vault RIM UUID as efe02baf-4fdc-44fa-ae39-e81ef4eeb4ef and click Save.
7. Optional: Use the RIM Maintenance Extract and Load functions to set up Content Plan Template Constraints to exclude or create records as inactive in the global content plan.

Creating Object Type Mapping Records

You will need to create new Object Type Mapping records to map the Global Submission and Global Application object types using the below information.

To do this:

1. Navigate to Admin > Business Admin and search the Components menu for Object Type Mapping.
2. Click Create and select Application Mapping in the dialog. Click Continue.
3. Enter the object type mapping details for Record 1 (below), then click Save.
4. Repeat the above steps for Record 2.

Record 1

• Name: application__v-global_application__v-drug__v to submission__v-global_submission__v
• Object Type: Application Mapping
• Source Object Name: application__v
• Source Object Type Name: global_application__v
• Target Object Name: submission__v
• Target Object Type Name: global_submission__v
• Source Applicable Product Type: Drug

Record 2

• Name: application__v-global_application__v-medical_device__v to submission__v-global_submission__v
• Object Type: Application Mapping
• Source Object Name: application__v
• Source Object Type Name: global_application__v
• Target Object Name: submission__v
• Target Object Type Name: global_submission__v
• Source Applicable Product Type: Medical Device

Updating Content Plan Item Template Records

Aligning Lead Market Country and Region Fields

In order for the Activity filter to display the applicable country and region-specific records, Content Plan Item Template records which are descendants of country and region-specific Content Plan Templates need to be set with the same country and region value. Perform a bulk update from the Content Plan Template viewer or use Vault Loader to align the Lead Market Country and/or Region fields within all descendant Content Plan Item Template records of Content Plan Templates which have the Country and/or Region populated.

For example, for the US module 1, all descendant Content Plan Item Templates within this m1 section should be set with Region “North America” and Country “United States”.

Assessing the Repeat on Document Set Field

Consider whether your organization plans to use Document Sets to distribute different documents and records across different countries. If so, review your Vault’s existing Content Plan Item Template records and, for any record where Vault should create repeating Content Plan Items for each document set, select the Repeat on Document Set field.