# 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 RIM Vaults, [global content planning](/en/lr/77852/) expedites core document assembly for local submission by joining event and activity management and local dispositioning with Submissions and content planning.



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      <p><strong>Note</strong>: This feature is available in Vaults licensed with both RIM Submissions and RIM Registrations. Users in RIM Submissions-only Vaults can create and manage global submissions and content plans manually, but without Event planning and dispatch capabilities.</p>
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## Configuration Overview

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

1. [Configure][1] the _Global Application_ and _Global Submission_ object types and update other _Application_ and _Submission_ object types to support global content planning.
2. [Add][2] the _Event Source_ field to _Submission_ relationship objects and page layouts.
3. [Configure][3] 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][4].
5. [Configure][5] new workflows for creating and updating global content plans.
6. [Update][6] the _Event_ object lifecycle with additional user actions and workflows.
7. [Configure][7] user permissions.
8. Create and update [master data records][8].
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](/en/lr/30704/#delete-inactive-content-plans) 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](/en/lr/77855/) for details.
11. Recommended: Configure your Vault to dispatch documents only based on the template module. See [Configuring Content Plan Synchronization](/en/lr/77855/#dispatch-documents-only) for details.
12. Optional: Configure your Vault to validate _Activity_ and _Submission_ lifecycle states during dispatch. See [Configuring Content Plan Synchronization](/en/lr/77855/) for details.
13. Optional: [Configure](/en/lr/71560/#configuring-active-dossier-generation-from-global-content-plan-dispatch) Vault to generate [Active Dossier](/en/lr/71782/) records from a [Global Content Plan dispatch](/en/lr/77853/).

## 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](/en/lr/77852/#about-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][10] for more information and configuration options.
5. Optional: Review your Vault's _Applications_ and _Submissions_ [tab](/en/lr/23516/) 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. If the _Template Constraint Type_ field is included on this object type, there should be no default value set, as this field value is copied from the _Event_ for Global Content Plans.

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](/en/lr/77852/#dispatching-global-content-plans).


## 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](/en/lr/77852/#dispatching-global-content-plans).

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](/en/lr/77852/#about-document-sets), update the layout to display the _Document Set_ field within the **Related Activities** section. See [Configuring Document Sets][10] 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](/en/lr/77852/#about-document-sets), add _Document Set_ (`submission_grouping__v`). See [Configuring Document Sets][10] 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 the Event Lifecycle {#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][5] and system actions. See [Managing Content Plans with a Lifecycle](/en/lr/45365/) for more information.

To do this, configure the following [workflow user actions](/en/lr/59885/#user-action-types) 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_.

You can create a Global Content Plan (GCP) as a baseline from a reference Application using documents from Active Dossier.

To do this, configure the _Create Global Content Plan_ action in the _Event_ lifecycle:

1. In the _Event_ lifecycle, select **Create Global Content Plan**.   
2. Click **Match Documents From**. 
3. Optional: Select **From Source Global Content Plan**. 

### Additional Configuration Options {#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](/en/lr/45365/#about-content-plan-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 {#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](/en/lr/31322/) 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_](/en/lr/53688/#subs-enable-app-relationships) setting enabled, Vault leverages relationships from the _Applications_ of the target submissions during dispatch.

When configured with the [**Copy Relationships**][9] option, Vault also checks for missing _Application_ relationship records and copies them to the target _Application_ and target _Submission_ records accordingly. See [Copy Relationships][9] for more details.

#### Validate Matched Documents are Locked {#validate-document-lock}

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](/en/lr/77853/#dispatch-logic-validation) 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](/en/lr/71560/#configuring-active-dossier-generation-from-global-content-plan-dispatch) 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](/en/lr/46496/) in the global content plan.



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      <p><strong>Note</strong>: The <em>Enable Global to Local Manufacturing Site Role Mapping</em> setting and related <em>Manufacturing Site Role</em> Constraints are not supported when <a href="/en/lr/77853/">dispatching</a> a <a href="/en/lr/77855/#manufacturing-site-role-note">global content plan</a>.</p>
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### Creating Object Type Mapping Records

You will need to create new [_Object Type Mapping_ records](/en/lr/62601/) 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](/en/lr/59502/#using-bulk-actions) from the Content Plan Template viewer or use [Vault Loader](/en/lr/26607/) 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 {#assessing-repeat-on-document-set}

Consider whether your organization plans to use [Document Sets][10] 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.

[1]: #configuring-application--submission-object-types
[2]: #configuring-the-event-source-field
[3]: #configuring-the-event-object--object-types
[4]: #configuring-additional-fields--page-layouts
[5]: #configuring-global-content-plan-workflows
[6]: #configuring-the-event-lifecycle
[7]: #configuring-user-permissions
[8]: #updating-master-data
[9]: #copy-relationships
[10]: #configuring-document-sets
[11]: #assessing-repeat-on-document-set
[12]: #additional-configuration-options
[13]: #validate-document-lock