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.
Note: This feature is available in Vaults licensed with both RIM Submissions and RIM Registrations with configuration by an Admin. This article assumes that your Vault follows the recommendations in Configuring Global Content Plans.
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:
- Navigate to an Event record.
- In the Actions menu, select Create Global Content Plan.
- In the dialog, select a Global Application and Content Plan Template, then click Start. Vault initiates the process to create the global content plan. 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. Therapeutic Indication and Pharmaceutical Form relationships are copied to the Global Application.
- 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.
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”, “No Regulatory Action Required to Implement”, or “No action”.
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.
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:
- Navigate to an Event record, or to an existing Global Submission.
- In the Actions menu, select Update Global Content Plan.
- 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
- 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.
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
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’s Document Set is blank, all records with a Document Set are 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 for details.
About Document Sets
Note: In RIM Vaults created on or before 22R1, the Document Set and Repeat on Document Set fields are known as Submission Grouping (submission_grouping__v) and Repeat on Submission Grouping (repeat_on_submission_grouping__v), respectively. These fields are relabeled to Document Set and Repeat on Document Set in Vaults created on or after 22R2.
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.
By default, you can select a single Document Set. When configured 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 Se 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 for details on the permissions required to work with global content plans.