# Using 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 expedites core document assembly for local submission by joining event and activity management and local dispositioning with Submissions and content planning.
## Creating Global Content Plans from an Event {#creating-global-content-plans-from-an-event} With the _Create Global Content Plan_ action, you can create a Global Content Plan from an _Event_ record. To create a global content plan: 1. Navigate to an **Event** record. 2. In the **Actions** menu, select **Create Global Content Plan**. 3. In the dialog, select a **Global Application** and **Content Plan Template**, then click **Start**. Vault initiates the process to create the global content plan. 4. When configured, you can also select **Match Documents From** in the dialog. Select **Active Dossier**. Select a reference **Application** then click **Start**. 5. When complete, you'll receive a notification. ### How Vault Creates Global Content Plans When you create a global content plan from an _Event_, Vault: * Creates a _Global Submission_ under the selected _Global Application_. * Copies the _Event_ record relationships (for example, _Event Clinical Study_) as specified by the _Use for Content Planning_ field to the _Global Submission_. * For _Event_ relationships with custom matching fields, Vault includes Text, Number, Date, DateTime, Yes/No, Picklist, Object, Lookup, and Long Text field values when copying the Global Submission. * _Therapeutic Indication_ and _Pharmaceutical Form_ relationships are copied to the _Global Application_. * Vault creates the _Global Application_ and _Global Submission_ relationships in the following order: * _Application Pharmaceutical Form_ (`application_pharmaceutical_form__v`) * _Application Indication_ (`application_indication__rim`) * _Submission Active Substance_ (`submission_active_substance__rim`) * _Submission Indication_ (`submission_indication__rim`) * _Submission Product_ (`submission_pharmaceutical_product__rim`) * _Submission Nonclinical Study_ (`submission_nonclinical_study__rim`) * _Submission Clinical Study_ (`submission_clinical_study__rim`) * _Submission Inactive Ingredient_ (`submission_inactive_ingredient__rim`) * _Submission Pharmaceutical Form_ (`submission_pharmaceutical_form__v`) * Creates a _Country_ relationship for each related Activity's _Impacted Market_ on the Global Submission. Vault also adds the relationship to the Global Application if one does not already exist. * Creates a _Submission Country_ relationship for the _Country_ referenced in the parent Application's _Lead Market_ field.  * If an _Application Country_ relationship doesn't already exist for the _Lead Market_, Vault creates the relationship prior to creating the _Submission Country_ relationship. * If any of the in-scope Activities reference the same _Impacted Market_ as the Application's _Lead Market_, Vault creates corresponding _Submission Languages_ for the _Country_. * Populates the _Global Submission Name_ with _Event Name_. * Copies _Content Plan Template_ and _Template Constraint Type_ field values from the _Event_ to the _Global Submission_. To create the global content plan, Vault generates: * A Content Plan for the _Global Submission_ based on the _Content Plan Template_. Vault also sets the newly-created Content Plan on the _Event_. This is the global content plan. * Repeating sections for each _Global Submission_ relationship where a token is used in the _Content Plan Template_ record _Name_. * Country and region-specific _Content Plan_ and _Content Plan Item_ records which match the country or region set on the related activities' _Impacted Markets_. * Repeating _Content Plan Item_ records based on the related activities' _Document Sets_. Vault excludes _Activity_ records where _Local Disposition_ is indicated as "Not Applicable" or "No Regulatory Action Required to Implement". When creating a _Global Content Plan_, Vault sets the _Event Source_ field within its newly-created _Submission_ relationship records (for example, _Submission Clinical Study_) to reference the _Event_ relationship record from which it was created. When this field is populated, the submission relationship record cannot be edited. ## How Vault Matches Documents from Active Dossier With the _Create Global Content Plan_ action, you can create a Global Content Plan (GCP) as a baseline from a reference Application using documents from Active Dossier. When you create a global content plan from Active Dossier, Vault automatically pulls the current document versions for the selected reference Application in Active Dossier and matches them into the newly created GCP structure using Active Dossier Mappings. Vault uses the _Event’s_ scope to filter the Active Dossier and map the relevant documents into the GCP using mappings, locking them to the current version. Relationship matching and document mapping is supported for these repeating section records: * Product * Active Substance * Inactive Ingredient * Clinical Study * Nonclinical Study * Indication Please note that the Comparison Viewer is not currently supported. Documents are automatically matched based on the mapping process. Results include a warning file to inform users of any documents for which a matching relationship could not be found and an unmapped documents file for any documents with no target Content Plan Items (CPIs) or multiple target CPIs found. ## Updating Global Content Plans {#updating-global-content-plans} After the Global Content Plan is initially created from an event, new _Event_ relationships and _Activity_ records can be re-synchronized with the Global Submission and added to the global content plan using the _Update Global Content Plan_ action. To update a global content plan: 1. Navigate to an **Event** record, or to an existing **Global Submission**. 2. In the **Actions** menu, select **Update Global Content Plan**. 3. Vault initiates the process to update the content plan. When complete, you'll receive a notification. ### How Vault Updates Global Content Plans During the _Update Global Content Plan_ action, Vault: * Copies any missing relationships from the Event to the Global Submission as specified by the _Use for Content Planning_ field * Creates any missing _Country_ relationship on the Global Submission based on the related Activity's _Impacted Market_. Vault also adds the relationship to the Global Application if one does not already exist. * Inactivates any relationships on the Global Submission if the _Event_ relationship has been deleted * Updates select fields on the Global Submission relationships that have changed on the respective _Event_ relationship records. For _Event_ relationships with custom matching fields, Vault includes Text, Number, Date, DateTime, Yes/No, Picklist, Object, Lookup, and Long Text field values when copying the Global Submission. * Triggers the _Update Content Plan_ action that creates new sections in the global content plan for any newly added relationships. The global content plan records for relationships that have been inactivated or where fields have been updated are not impacted. ## Reparenting Global Content Plan sections cannot be reparented from one Global Content Plan into a different GCP by manually updating the Parent field. You can copy into a Global Content Plan section by dragging and dropping from one GCP to another. You can reparent sections from one part of a hierarchy to another within the same Global Content Plan and to or from a Submission Content Plan. ## Viewing Global Content Plans The Content Plan Hierarchy Viewer helps you easily navigate within a content plan. You can launch the viewer by clicking the Content Plan icon from an _Event_ or _Activity_, or by selecting **Global Content Plan** from the **Actions** menu. When you view the content plan from an _Event_, the viewer displays all available data. When viewing from an _Activity_, Vault applies a special filter to display only the relevant content for the selected _Activity_ based on its _Country_, _Region_, and _Document Set_. ### About the Activity Filter You can apply the **View by Activity** filter directly from a **drop-down menu** in the Content Plan Viewer header when viewing a Global Content Plan. When you view a Global Content Plan from an _Activity_, Vault loads and displays only the content plan and content plan items which fit the filter criteria. Vault displays or hides records as follows: * Records with a _Lead Market_ that match the _Activity's_ _Impacted Market_ are displayed. If _Lead Market_ is blank and _Region_ is populated, Vault displays records with a _Region_ that match the _Activity'_ _Impacted Market's_ _Region_. * If the _Activity's_ _Impacted Market_ is blank, all records with a _Country_ or _Region_ are displayed. * Records with at least one _Document Set_ that matches at least one of the _Activity's_ _Document Sets_ are displayed. If the _Activity_ has no _Document Sets_, all records with a _Document Set_ are filtered out. * Based on system configuration, records with no _Document Set_ are either included or filtered out. * Records where _Lead Market_, _Region_, or _Document Set_ are blank are always displayed for all Activities. When working with the filter, additional special Vault behaviors apply: * **Excel Tree with All Descendants** exports include up to 10,000 _Content Plan_ and _Content Plan Item_ records fitting the _Activity_ filter criteria. _Application_, _Submission_, and _Submission_ relationships are not included in _Activity_-filtered global content plan exports. * You cannot include the _Activity_ filter in a saved view. If you create a saved view when the _Activity_ filter is applied, all column and filter settings except for the _Activity_ filter are saved. * Vault stores the _Activity_ filter in the content plan's URL, which you can use to navigate directly to a filtered global content plan. ## Dispatching Global Content Plans Vault provides two initiation points for dispatching _Global Content Plans_ to up to 250 market-specific _Submission Content Plans_: * From an _Event_ record * From a _Content Plan_, primarily within the Content Plan Viewer The available options depend on your Vault's configuration. See [Dispatching & Synchronizing Content Plans](/en/lr/77853/) for details. ## About Document Sets {#about-document-sets}
Using the _Document Set_ object allows you to track meaningful names, longer text definitions, owners, and planned vs. actual complete dates. A lifecycle is available to communicate the status of individual _Document Sets_ among global teams and can be configured with custom workflows to enforce business processes. Using the _Document Set_ field, your organization can maintain one Global Content Plan that handles document variations for different groups of markets. The _Activity_, _Country_, _Application_, and _Content Plan Item_ objects use the _Document Set_ picklist to categorize document groups. Then, Vault uses the selected _Document Set_ value or values to filter the global content plan records in the dispatch so that each local submission receives the applicable document set. ### Creating Document Sets You can create _Document Sets_ and assign them to _Activities_ from the custom application section on the *Event* page layout. You can create them from scratch or from _Document Set Template_ records pre-configured by business users. To create a _Document Set_ record: 1. Navigate to an **Event Record**. 2. In the _Documents Set_ related object section, select **Create** or **Create from Template**. When using the **Create** option, populate fields in the dialog and **Save** or **Save and Create**. Selecting **Create from Template** opens a dialog to select template values. 3. Click **Save**. If the Event already has Document Sets created from template records, those Document Set Template records are filtered out of the dialog. This indicates that the dialog can only be used to create new Document Sets from template, but not to delete Document Sets that have already been created by template. This ensures there is only one Document Set per template record within the context of a single Event. #### Limitations * Users can only inline edit 100 records to select Activities. More than 100 Activities can be added using the Show More/advanced search dialog. * Activity values are displayed up to a limit of 3 rows of text per Document Set record. ## Using the Document Set Picklist Model
By default, you can select a single _Document Set_. When [configured](/en/lr/77854/#configuring-document-sets) by an Admin, you can select multiple _Document Sets_. This allows you to accommodate scenarios such as: * When different document sets are applicable for a _Country_/_Activity_ based on content from a functional area. For example, you can have one _Document Set_ each for CMC and Clinical. * When a _Content Plan Item_ is relevant for multiple document sets. Instead of matching the same document to multiple _Content Plan Item_ records, you can set the applicable _Document Sets_ on a single _Content Plan Item_ record. See the use cases below for more examples. ### Use Case: Single Document Set A _Content Plan Item Template_ record, "Description of Manufacturing Process and Process Controls" has the _Repeat on Document Set_ field selected. The related _Event_ used to create the content plan has four _Activities_, shown in the table below: |Activity|Local Disposition|Document Sets|Related Submission| |--- |--- |--- |--- | |1|Implement then file|Group A|Submission 1| |2|Implement then file|Group A|Submission 2| |3|Not applicable|Group B|None| |4|Implement then file|Group C|Submission 3| When Vault creates the Global Content Plan, it creates one _Content Plan Item_ record ("Description of Manufacturing Process and Process Controls"), for each applicable document set (Group A and Group C) under the parent 3.2.S.2.2 Description of Manufacturing Process and Process Controls Content Plan. Vault does not create _Content Plan Item_ records for _Activity_ 3 because the local disposition is "Not applicable". When Vault completes dispatch of the Global Content Plan, the Content Plan created for Submission 1 and Submission 2 contains only the Group A "Description of Manufacturing Process and Process Controls" _Content Plan Item_ record. The Content Plan created for Submission 3 contains only the Group C "Description of Manufacturing Process and Process Controls" _Content Plan Item_ record. Vault does not create a content plan for _Activity_ 3, since there is no related submission. ### Use Case: Multiple Document Sets A Vault user at VernBio headquarters (HQ) creates a global content plan for a variation from an _Event_ record. The _Activity_ records for each market have associated document sets as follows: |Activity|Country|Document Sets| |--- |--- |--- | |1|Canada|CMC A
Clinical A| |2|Australia|CMC A
Clinical B| |3|Thailand|CMC B
Clinical B| |4|Brazil|CMC B
Clinical C| _Document Sets_ Clinical A and Clinical B both require the same document to be included in the dispatch to the impacted markets, so the VernBio HQ user matches it to a _Content Plan Item_ and sets the _Document Set_ field on the _Content Plan Item_ to include both the Clinical A and Clinical B document sets. When the HQ user dispatches the global content plan, Vault dispatches the _Content Plan Item_ to _Activities_ 1, 2, and 3. Vault does not dispatch to _Activity_ 4, since it does not include the Clinical A or Clinical B document sets. ## Related Permissions See [Configuring Global Content Plans](/en/lr/77854/) for details on the permissions required to work with global content plans. [1]: #about-document-sets