Working with Content Plans

Submission content plans help you collect the documents that you want to include in a single submission package. Content plans allow you to quickly assess which documents have been included and which documents are missing, and allow you to verify each document’s approval status to see if they are ready to be submitted.

After you’ve created an application and submission, you can use the submission to create a submission content plan.

Vault Admins and Submission Managers have access to create content plans in the Submissions tab, while Document Managers do not.

Working with content plans involves the following general steps:

1. Create the content plan from your submission.
2. Identify which document types you want to include in the content plan.
3. Add individual documents to the identified document types.
4. Approve and version-lock all matched documents.
5. Create a binder of the documents you want to submit and export it to a ZIP file.
6. Outside of Vault, share the ZIP file with your third-party publishing tool to send to the Health Authorities.
7. Lock the content plan and binder to reflect the published output that was submitted to the Health Authorities.

Viewing Content Plans

Complete the following steps to view submission content plans:

1. Navigate to the Submission Mgmt > Submissions tab and click the Content Plan name to open the content plan.
2. If a content plan section contains records, click the caret icons to expand or collapse each section individually.
3. From the content plan Actions menu, select Expand or Collapse to expand or collapse all items in the content plan tree.
4. Click Show Inactive to show inactive items in the content plan, and click Show Active to show active items only.

Creating Content Plans

Content plan creation follows several main tasks. First, create the content plan itself. Next, activate the items you want to include in the content plan. Last, change the content plan’s status to Ready for Use.

Your content plan and content plan items transition through several statuses during the creation process. When you first create the content plan, Vault assigns it the Inactive status. You can manually change individual content plan items or sections to Draft to indicate that you want to include those documents in the final submission. After identifying which items you want to include, you can change the status of the entire content plan to Ready for Use, which allows you to begin adding documents to the content plan.

Creating Content Plans

Complete the following steps to create a content plan:

1. Navigate to the Submission Mgmt > Submissions tab and click the Submission Name of the submission for which you want to create a content plan. From the All Actions menu, select Create Content Plan. The Start dialog is displayed with a message that indicates that the content plan will be created in an Inactive state.
2. Confirm that the selected Content Plan Template and Dossier Format are correct and click Start. A message is displayed to indicate that the content plan is being generated.
3. Once you receive a notification that the content plan has been generated, click the Notifications bell icon to open the Notifications panel.
4. Click the Content Plan Name link in the notification to open the content plan in the Submissions tab.

Activating Content Plan Items

After creating a content plan, you can begin activating the items you want to include in the content plan.

Complete the following steps to activate content plan items within a content plan:

1. Click Show Inactive in the upper-right corner of the page to show all inactive items added from the template you selected for your content plan.
2. In the content plan tree in the left panel, locate each item you want to activate and include in the content plan, and select Change State to Draft from the content plan item Actions menu. The status for that item changes to Active.
3. If you want to deactivate an Active item, select Change State to Inactive from the content plan item Actions menu. The status for that item changes to Inactive.
4. When you have finished activating the items you want to include in the content plan, click Hide Inactive and review the items you changed to Draft.

Changing Content Plans to Ready for Use

Once you have finalized the content plan items you want to include in the content plan, you can set the content plan to Ready for Use, which allows you to add documents to the content plan items.

To change a content plan to Ready for Use, select Change State to Ready for Use from the content plan Actions menu. Once Vault finishes processing the status change, Ready for Use is displayed next to the content plan name. When you change a content plan to Ready for Use, Vault automatically changes the status of its corresponding submission to In Process.

Updating Content Plans After Changing Submission Relationships

If you make changes to the relationships in your content plan’s corresponding submission, you can use the Update Content Plan action to ensure that your content plan reflects the correct set of documents needed for your submission. Because your content plan is derived from the relationships in your submissions, any changes to the submission relationships directly affect the content plan.

Complete the following steps to update a content plan after changing submission relationships:

1. Navigate to the Submission Mgmt > Submissions tab and click the Submission Name of the submission for which you want to update the content plan.
2. From the All Actions menu, select Update Content Plan. Vault updates the content plan with any changed submission relationships and displays a message when the content plan has been successfully updated.

Adding Documents to Content Plans

To complete your content plan, you must add documents to the active content plan items. If the documents you want to add already exist in Vault, use Match Document Mode to find and match the existing documents to the content plan items. If the documents do not yet exist in Vault, add the new documents directly to the content plan items.

Adding Existing Documents

Complete the following steps to match an existing document to a content plan item using Match Document Mode:

1. From the content plan item Actions menu, select Match Document Mode. A Match Documents view is displayed to the right of the content plan tree, and Vault suggests matching documents based on the Application, Submission, and Classification of the documents.
2. Modify the document filters as needed to find the document you want to match to the content plan item.
3. Select the document checkbox for the document you want to match to the content plan item.
4. Refresh your browser to view the status of the content plan item.

Adding New Documents

If the document you want to add to a content plan item does not yet exist in Vault, you can upload a new document directly to a content plan item either by dragging and dropping the file or by using the Actions menu.

Adding New Documents Using Drag and Drop

Complete the following steps to add a new document to a content plan item using drag and drop:

1. In Submission Mgmt > Submissions, and expand all content plan items.
2. Open the file browser on your system and locate the document file you want to add.
3. Drag and drop the document file from your file browser onto the content plan item you want to add the document to in your Vault web browser. The Upload File (Step 2) dialog is displayed. Vault automatically determines the document’s name and product information based on the content plan item information.
4. Update the document’s Name as needed.
5. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.
6. Click Save. A message is displayed to indicate the upload is successful, the document is saved to Vault with a status of Draft, and the content plan item status is updated.

Adding New Documents Using the Actions Menu

Complete the following steps to add a new document to a content plan item using the Actions menu:

1. Select Upload from the content plan item Actions menu. The Upload Files (Step 1) page is displayed.
2. Click Upload, select the documents you want to upload, and click Open. Vault automatically determines the document’s Classification based on the content plan item information.
3. Click Next. Vault automatically determines the document’s Name, Product Family, Applications, and Submissions based on the associated content plan and content plan item information.
4. Update the document’s Name as needed.
5. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.
6. Click Save.
7. Click Back to previous page to return to the content plan.
8. If needed, update the Name, Product Family, Applications, and Submissions associated with the document and click Save. A message is displayed to indicate the upload is successful, the document is saved to Vault with a status of Draft, and the content plan item status is updated.

Removing Documents

To remove a document from a content plan item, select Remove Document from the document Actions menu for the document associated with the content plan item.

Reviewing Content Plan Completeness

Before a content plan can be considered ready for use, all content plan items must be in a Complete state.

Content Plan Item Status Icons

The below status icons are displayed next to each content plan item to indicate the current status. For additional information, hover over the status icon next to the content plan item.

Icon	Status	Description
	Inactive	The content plan item is inactive.
	Not Started	The content plan item is active, but it is not matched to a document.
	In Progress	The content plan item is matched to two (2) or more documents.
	In Progress	The content plan item is matched to an unapproved document.
	In Progress	The content plan item is matched to an approved document, but the document has not been version-locked.
	Complete	The content plan item is matched to an approved version-locked document.

Updating Content Plan Item Statuses

Complete the following steps to update content plan item statuses according to their current status:

1. Review the current content plan item status to determine the next steps.
2. Complete the following steps for active content plan items without a matched document ():
   1. Add a new document or match an existing document to the content plan item as needed.
   2. Refresh your browser and reassess the status of the content plan item to determine the next steps.
3. Complete the following steps for content plan items matched to an unapproved document ():
   1. Click View in Mini-Browser to the right of the associated document in the content plan tree to open it in a separate pop-up window.
   2. Manually approve the document or initiate the document approval workflow as needed.
   3. Close the pop-up window.
   4. Once the document is approved, refresh your browser and reassess the status of the content plan item to determine the next steps.
4. Complete the following steps for content plan items matched to two (2) or more documents ():
   1. Determine whether you want to remove the extra documents or split the content plan item into multiple items to allow for including multiple documents of the same type:
      • If you want to remove the extra documents, click View in Mini-Browser to the right of each matched document to determine which document to keep and which documents to remove, and then remove the extra documents from the content plan item as needed.
      • If you want to split the content plan item into multiple items, select Split Content Plan Items from the content plan item Actions menu. Vault splits the content plan items so that each added document has its own content plan item.
   2. Refresh your browser and reassess the status of the content plan item to determine the next steps.
5. Complete the following steps for content plan items matched to an approved but not version-locked document ():
   1. Version-lock an individual document or version-lock all documents as needed.
   2. Refresh your browser and reassess the status of the content plan items to determine the next steps.

Version-Locking Documents in Content Plans

When you lock a matched document to a specific version, that version remains locked to the content plan item even if the document becomes superseded or a newer version is approved.

Version-Locking Individual Documents

Complete the following steps to version-lock a matched document:

1. From the matched document Actions menu, select Lock Version. The Lock Matched Document Version dialog is displayed.
2. From the Select Eligible Version drop-down, select the approved version you want to lock to the content plan item.
3. Click Continue.
4. Alternatively, you can lock all unlocked matched documents at once by selecting Lock Version from the content plan Actions menu.
5. Refresh your browser to view the updated content plan item statuses.

Version-Locking All Documents

Complete the following steps to version-lock all matched documents in the content plan:

1. From the content plan Actions menu, select Lock Version. Vault displays a message to indicate that the unlocked matched documents are being version-locked to their latest steady state.
2. Once you receive a notification that the version-locking process is complete, refresh your browser to view the updated content plan item statuses.

Working with Binders

Once all content plan items are Complete and version-locked, you can create a binder from the content plan that can be published outside of Vault. You can create a binder of an entire content plan or only a specific section of the content plan. Once you have created a binder, you can export the binder, which creates a ZIP file with PDFs of each document in the binder.

Creating Binders from Content Plans

Complete the following steps to create a binder from a content plan:

1. From the content plan Actions menu, select Create Binder from Content Plan. A message is displayed to indicate that the binder is being created.
2. Once you receive a notification that the binder has been created, click the Notifications bell icon to open the Notifications panel.
3. Click the Binder Name link in the notification to view the binder in the Submissions tab in the Submission Mgmt tab collection.

Viewing Binders

Complete the following steps to view a binder and navigate its contents:

1. Navigate to the Submission Mgmt > Library tab.
2. If the Binders filter is not displayed in the Filters pane, click Edit next to the Filters heading.
3. In the Add Filter field, search for and select the Binders filter. The Binders filter is added to the Filters pane.
4. Expand the Binders filter and select the Yes checkbox. Use any additional filters to find the binder you want. Vault lists all matching binders.
5. Click the Binder Name to open the binder.
6. To view a binder using the Compact layout:
   1. From the Layouts menu, select Compact. The top-level sections of the binder are displayed.
   2. Click the binder section you want to open, and then click each section to navigate further in the binder’s hierarchy.
   3. To return to a previous section, click the section name link in the breadcrumbs.
   4. To view a document, click the document name.
   5. To return to the binder, click Back to binder.
7. To view a binder using the Outline layout:
   1. From the Layouts menu, select Outline. The top-level sections of the binder are displayed.
   2. Click Expand all to expand all binder sections. Vault displays all sections and documents in the binder in a tree view.
   3. Click Collapse all to collapse all binder sections.
   4. To view a document, click the document name.
   5. To return to the binder, click Back to binder.

Exporting Binders

Complete the following steps to export binder contents to a ZIP file:

1. Open the binder you want to export.
2. From the All Actions menu, select Export Binder. The Refine Selection page is displayed.
3. To export all binder contents, select the Export entire binder checkbox.
4. To export individual sections or documents, click Expand all and select the checkboxes for the sections and documents you want to export.
5. Click Next. The Choose Artifacts and Naming Rule page is displayed.
6. Select any of the following options as needed:
   • Select the Renditions checkbox if you want to export the renditions and select the type of renditions to export.
   • Select the Source Documents checkbox if you want to export the source files of the documents, for example, CSV or DOCX.
   • Select the Document Fields checkbox if you want to export a CSV file in the top-level binder folder listing each downloaded file and the associated document fields.
   • Select the Document Attachment checkbox if you want to export attachments that exist on the selected documents and select the version type you want to export.
   • Select the Document Audit Trails checkbox if you want to export the audit trails for the selected documents and then select the file type you want to export.
   • Select the document field from the Document Naming Rule drop-down that you want to use to name the exported document files.
   • Select the Version Selection option to determine which version of the selected documents to export.
7. Click Next. The Confirmation page is displayed.
8. Review the export rules summary. If you need to edit any of the information, click Back and update the information as needed.
9. Click Finish. A message is displayed to indicate that the binder is being exported.
10. Once you receive a notification that the binder has been exported, click the Notifications bell icon to open the Notifications panel.
11. Click Show More in the notification and click the ZIP file link to download the exported file to your selected download location.

Updating Binders with New Content

If updated documentation is available and you want to update your binder with the new content, you must add the updated documentation to the content plan, re-create the binder using the updated content plan, and then export the updated binder. When you re-create a binder, Vault updates the binder version to the next minor version.

Locking Binders & Finalizing Content Plans

After publishing and submitting an exported binder to the authorities, lock the binder by changing its status to Approved so that its contents are reflective of what was entered into your third-party publishing tool. Then, change the content plan’s status to Final to finalize the content plan contents used to create the binder that was published and submitted to the authorities.

Complete the following steps to update the binder and content plan statuses after submission to authorities:

1. Open the binder you want to lock and approve.
2. From the Workflow Actions menu, select Direct Approval. Vault changes the binder status to Approved, locks the binder from editing, and updates the version to the next major version.
3. Open the content plan you want to finalize.
4. From the content plan Actions menu, select Change State to Final. Vault changes the content plan status to Approved and locks the content plan from editing.