With report level content plans, you can compile and publish documents for clinical study and nonclinical study reports, and for product family reports that are not study-specific, such as Periodic Safety Reports and Investigator Brochures. This feature leverages content plans to enhance the pre-publishing process, and supports managing and publishing document reports in Vault that may later become part of eCTD submissions. For information about using submission content plans, see Using Submission Content Plans.
Note: This feature is only available on RIM Submissions Vaults.
How Report Level Content Plans Work
You can use report level content plans to efficiently assemble and prepare clinical study, nonclinical study, and product family reports. Report level content plans provide pre-set report structures based on content plan templates configured by your Admin. You can create these reports based on a content plan and match documents to the defined content plan structure. After matching documents, you can publish the content plan.
Vault publishes the documents based on the Published Output Location and Source for Published Document fields on the Content Plan Item object, converts Microsoft Word™ web links and Vault annotation links to standard PDF links with a relative path, and places the documents in a published Submission Ready binder.
Vault creates the published binder in the same structure as the content plan and includes published documents only. Vault also lets you export the published binder.
Creating & Updating Report Level Content Plans
To create report level content plans:
- Navigate to a Clinical Study, Nonclinical Study, or Product Family (
- Expand the Study Report or Product Family Report section and click Add.
- Click Create to create a new report. In the dialog, populate and save the report’s details. You can also add an existing report.
- Click Save.
- Click Ok to add the created record.
- From the newly-created record’s Actions menu, click Create Content Plan. This action may have a different name in your Vault.
- Vault begins creating the content plan. This process may take a while. When complete, you’ll receive a notification. Do not edit Content Plan records until you receive this notification.
Updating Report Level Content Plans
You can also update an existing content plan using the Update Content Plan action. Updating a content plan will create new Content Plan sections and Content Plan Item records based on the report record’s relationships and any updates to the template.
Vault creates these new sections and records under the root Content Plan record, ordering them alphabetically and placing them after existing sections. The order of existing sections does not change, even if record names change.
When executed on a Content Plan, the Update Tokens in Fields user action updates unresolved tokens in the Name, XML Title, and Published Output Location fields on all descendant Content Plan Item records. You can also update tokens on individual Content Plan Item records by performing a similar action, Update Tokens in Field.
To update unresolved tokens in a Content Plan, navigate to a Content Plan object record and select Update Tokens in Fields from the Actions menu. You’ll receive a notification when this process is complete.
To update unresolved tokens in an individual Content Plan Item, navigate to the Content Plan Item object record and select Update Tokens in Field from the Actions menu.
You can copy an existing content plan, including its entire hierarchy, relevant related object join metadata, and all matched documents, to a new content plan. This feature is particularly useful for expediting creation of a new study or product family report, as users can quickly copy an existing report with a similar structure and documents, then edit as required.
For example, VernBio’s medical writing team is assembling a report level content plan for a US-based clinical study, which shares many of the same documents as an existing Japan-based Clinical Study Report. To expedite creation of the US Clinical Study Report, the team runs the Copy Content Plan system action on the Japan-based Clinical Study Report, then matches documents within the newly-created US plan accordingly.
Note: An Admin must enable this feature by configuring an object workflow for the Report Level Content Plan object and adding the Copy Content Plan system action to the workflow.
How Vault Copies Content Plans
When you copy a content plan, Vault:
- Locks any matched documents on the existing content plan to the new content plan.
- Copies the following join records if a matching join record does not already exist on the target report level content plan record: Report Level Plan Clinical Study, Report Level Plan Nonclinical Study, and Report Level Plan Product Family. If a matching join record already exists, Vault references that record rather than creating a new one.
- Runs an update from the content plan template and creates any records that are missing from the template.
- Creates new sections in the new content plan if the target report contains Report Level Content Plan join records that don’t exist in the source report.
- Retains Inactive records in the copied plan if they were Inactive in the source content plan.
How to Copy Content Plans
To copy from an existing content plan:
- Navigate to a Clinical Study, Nonclinical Study, or Product Family record and create a Report Level Content Plan record from the Study Reports section.
- From the Actions menu of the Report Level Content Plan, choose Copy from Content Plan.
- Select the desired report level content plan whose content plan you want to copy from the Copy Content Plan picklist.
- Click Start. Vault begins copying the content plan from the selected report level content plan. When complete, you’ll receive an email and a Vault notification. Click the links in the notification to download a CSV file containing details about the copied components.
Copying Content Plan Sections
Using the Content Plan Hierarchy Viewer, you can copy sections between content plans to reuse existing content and prevent duplicate work. When you copy a content plan section, Vault includes the source Content Plan or Content Plan Item records and join records. You can also choose to copy matched documents and preserve version locking. See Using the Content Plan Hierarchy Viewer for more information.
While authoring submission content, you can create document permalinks within the source document that navigate users to other content within Vault. Cross-document links in MS Word™ documents can persist even as content changes during the authoring process. When enabled, Vault also converts links targeting destinations to links targeting a page and coordinates. See Using Dynamic Linking for more information.
To allow Vault to generate a Table of Contents (TOC) document:
- Open the appropriate Content Plan Item record.
- Set the Node Type (
xml_node_type__v) field to Table of Contents.
- In the Publishing Element field, select the TOC template.
- Select the Full Document Type.
- Click Save.
- Repeat these steps for each TOC that you want to include in your content plan.
After you set up a Content Plan Item record to support a TOC, select the Generate Publishing Table of Contents action from the record’s Actions menu. Vault generates the TOC document from the template referenced on the related Publishing Element record, classifies it based on the value in the Document Type Detail field on the Content Plan Item, sets the the Ready for Publishing field to Yes, and matches the TOC to the Content Plan Item record.
When your Admin has configured the TOC to use sequential page numbering, Vault will use zero (0) as a placeholder for page numbers in the generated TOC. For example, if the total number of pages is 1,000, the placeholder page number will be “0000000.” Vault will replace these placeholders when merging the published content plan into a single PDF. See details about document merging below.
Using an Overlay
An Admin can configure an overlay template for a content plan item. When publishing, Vault applies the overlay to the content plan item’s matched documents. You can also set a default overlay by configuring the Default Overlay field on the Report Level Content Plan record.
Publishing without document merging follows standard rules for applying overlays. Vault applies the overlay defined in the content plan item’s Publishing Element record. If no Publishing Element exists on the content plan item, Vault applies the default overlay. If the Publishing Element exists but does not define an overlay, Vault does not apply an overlay.
When publishing with document merging, Vault applies the default overlay in all cases.
Using Content Plan Hierarchy State Changes
To help you manage complex content plan hierarchies, Vault includes several options to cascade lifecycle state changes from a Content Plan or Content Plan Item record:
- Vault can move Content Plan records to new lifecycle states automatically when their descendant records move to new states. For example, Vault can move ascendant Content Plan records to an active lifecycle state when a Content Plan Item record moves from Inactive to Draft.
- Vault can change the state of the current Content Plan record and all of its descendant Content Plan and Content Plan Item records asynchronously.
See Content Plan Lifecycle State Changes for details about these options.
Once your documents have been finalized and matched to Content Plan Item records, you can publish the report directly from the content plan. Vault bases the published output type on the Source for Published Document field, creates a new document from the matched document, and names the new document based on the filename specified in the Published Output Location field.
Vault does not publish any documents matched to inactive Content Plan Item records or any documents that do not have the Ready for Publishing field set to Yes. If you’ve matched a CrossLink document to a content plan item, Vault treats the CrossLink’s viewable rendition as a standard document during publishing.
How to Publish Documents
To publish documents from a content plan:
- Navigate to the root Content Plan record.
- From the record’s Actions menu, click Publish Report. This action may have a different name in your Vault, or you may see an option to Publish & Merge. You may also see both options. See details about merging and publishing documents below.
- Vault begins publishing the report. This process may take a while. When complete, you’ll receive a notification with a link to download a CSV file outlining results.
Vault automatically creates a Source References relationship between the source document and the published Submission Ready document.
When configured by an Admin, the Merge and Publish Content Plan user action allows you to combine all matched documents within a content plan into a single merged PDF during the publishing process. To support authoring at a lower level of granularity, Vault also allows you to merge multiple documents assigned to a Content Plan Item into a single merged PDF.
See Merging & Publishing Content Plans & Items for more information.
After you publish a report, you can access published documents and document details by navigating to the desired content plan in the Content Plan Hierarchy Viewer. The published document details are based on the following Content Plan Item fields:
Published Output Location: This field defines the folder path and filename of where the published document will reside. Vault uses this field to create standard PDF links with a relative path from MS Word™ inter-document links and Vault link annotations. When editing the field, you must include the folder path in addition to the filename. For example, use report/report-body.pdf instead of report-body.pdf. Depending on your configuration, this field may already be populated and may not appear on your page layouts. The Published Output Location field has a 100-character limit. If it exceeds the character limit, Vault cannot publish or publish/merge.
- Source for Published Document: This field defines the rendition used as the source for the published document. For example, if you specify Viewable Rendition as the source, Vault will use the viewable rendition of the matched document as the source to create the published document. The Source for Published Document must correspond to the filename extension specified in the Published Output Location field. For example, if you specify Source Document as the source, and the matched document is a DOCX file, the Published Output Location filename should have .docx as the extension. If you specify Source Document as the source, Vault publishes any CrossLink documents using the CrossLink’s viewable rendition as the source.
- Published Document: Vault populates this field with a link to the published document based on the matched document. The published document is created from the matched document’s version at the time of publishing. For this reason, we recommend locking a matched document to the Content Plan Item record to a desired document steady state.
These fields are defined by your Admin’s Content Plan Item Template configuration. However, if you have the correct permissions, you can use inline editing to modify the Published Output Location and Source for Published Document fields from the viewer.
Link Annotations & Link Publishing
You can create link annotations on documents within Vault. Report level content plans leverage Vault’s link annotation functionality by converting link annotations or MS Word™ links to standard relative PDF links upon publishing. This allows you to create cross-reference links once documents are finalized and before inclusion in any submission.
You can create links between two documents within Vault outside the context of a report. When you publish a document, Vault compiles the link annotations within the document and converts them to standard PDF links with a relative path to the target document, determined by the Published Output Location (
xml_xlinkhref__v) field. This allows for easy navigation to referenced pages within a target document.
Dynamic Link Publishing
During the publishing process, Vault converts Microsoft Word™ Web Links created with copied bookmark or destination links in Vault to standard PDF hyperlinks with relative paths based on the Published Output Location (
xml_xlinkhref__v) field on the Content Plan.
Link Publishing Limitations
- Vault ignores link annotations created in the source Vault when publishing CrossLinks documents.
- During publishing, Vault renders all links to display in blue text, even if this setting isn’t enabled in your Vault.
Table of Contents Publishing
When you publish the report level content plan, Vault automatically performs the following actions for any Content Plan Item records with the Node Type (
xml_node_type__v) field set to Table of Contents:
- Generates and publishes a TOC document, using the related Publishing Element record to determine the template for the TOC
- Classifies the TOC document based on the value in the Document Type Detail field on the Content Plan Item
- Sets the Ready for Publishing field to Yes on the TOC document
- Matches the TOC document to the Content Plan Item; if a document is already matched, Vault versions it
During publishing, Vault regenerates, versions, and publishes the TOC document. If you update the Node Type (
xml_node_type__v) field on the Content Plan Item, Vault deletes or generates the TOC document accordingly. If you update the TOC template, you’ll need to use the Generate Publishing Table of Contents action to regenerate the TOC.
When you publish a report level content plan from source, Vault applies the overlay defined in the content plan item’s Publishing Element record. If no Publishing Element exists on the content plan item, Vault applies the default overlay. If the Publishing Element exists but does not define an overlay, Vault does not apply an overlay.
To prevent unnecessary continuous publishing operations, Vault updates overlays on previously published documents only when you do one of the following:
- Update the Default Overlay field on the Report Level Content Plan record. This only re-publishes content plan items that don’t reference a Publishing Element.
- Update the Publishing Element field of a Content Plan Item record.
Updating the Overlay field on a Publishing Element record does not re-apply the overlay to previously published documents and only affects future documents. To apply the new overlay, you must re-publish the Content Plan Item using the On-Demand Publishing action.
When you publish a report level content plan, Vault validates the content plan as well as the published content. Vault creates one Submission Validation Result record for each validation criterion performed against each content plan item in the content plan. You can view these from the Submission Validation Results section on the Content Plan Item record details page. Vault deletes values in existing Submission Validation Result records and creates new ones each time the Content Plan is published.
Vault also archives all Submission Validation Result records into a single XML file 365 days after the content plan is published so you can reference validation results without cluttering your Vault with unnecessary object records.
See Working with Submission Validation Results for complete details about validation results.
The Content Plan Hierarchy Viewer helps you easily navigate within a report level content plan to access published documents and details. Navigate to the Report Level Content Plan record and click the Open Tree View button to open it in the viewer. The Actions menu on the Report Level Content Plan record also provides an option to View Content Plan.
Viewing Matched & Publishing Documents
When you select the Open Matched Documents or Open Publishing Documents actions from a Content Plan Item record’s Actions menu, the document opens in a new mini-browser window for easy document review. Clicking a link within that document, or opening another matched or published document, refreshes the current mini-browser window to display the new link target or document. Vault opens a separate mini-browser for each browser tab or window in which you’re working.
You must enable pop-ups in your browser to see the mini-browser window.
Viewing Publishing Progress
Vault automatically updates the status indicator icon (or harvey ball) in the Publishing Status field to inform you if there are outstanding publishing or validation jobs. This ensures that you only review and submit content after it has been published and validated. See Viewing Publishing Progress for details.
Viewing the Submission Ready Binder
Once Vault creates the Submission Ready binder, you can click the View Submission Ready Binder icon to open the binder directly from the root Content Plan record, Report Level Content Plan record, or the Content Plan Hierarchy Viewer. You can also select the action from the Actions menu on the root Content Plan or Report Level Content Plan record.
After publishing the content plan, you can export the binder with a document type of Submission Ready and select specific components within the structure if needed. The exported ZIP file represents the folder structure as defined on the Published Output Location and Source for Published Document fields on the Content Plan Item object.
To export a Submission Ready binder, select Export Binder from the root Content Plan record’s Actions menu. This action only works when selected from the root-level content plan section. You can also select Export Binder directly from the binder’s Actions menu.
About the System User
Vault executes the Create Content Plan and the Update Content Plan actions as the System User instead of the user who initiated the action. You’ll see System in the created record’s audit trail, the Created By field, and in the Owner role if Dynamic Access Control is enabled.
Vault also executes the Publish Report action as System User. Vault cannot up-version or republish Submission Ready binders.
Notifications & Error Logs
When Vault finishes creating a report level content plan, publishing content, or exporting a binder, you receive an email and a Vault notification. Wait until you receive a notification before navigating to the report level content plan.
The following permissions control your options for report level content plans:
|Security Profile||Object: Content Plan||Ability to create and edit records. This is necessary to create content plans from templates and publish a content plan.|
|Security Profile||Object: Content Plan Item||Ability to create and edit records. This is necessary to create content plans from templates and publish a content plan.|
|Security Profile||Object: Report Level Content Plan: Object Action: Submission Ready Binder||Ability to access the Open Submission Ready Binder action and button from the Report Level Content Plan record or the Content Plan Hierarchy Viewer.|
|Document Role||View Document||Ability to export the binder.|
|Document Type||Create Binder||Ability to create binders with this document type. You need this permission on the Submission Ready document type.|
In existing Vaults, Admins can update these objects manually.