Using Submission Content Plans (RIM)

With submission content plans, you can plan, track, and assemble all the documents you need to include with a submission. The type and number of expected documents can vary between submissions based on the selected content plan. This may also vary based on the related application’s Lead Market country.

Submission content plans use the EDL and EDL Item objects (relabeled) with some RIM-specific functionality. Various labels may be different in your Vault, depending on your configuration. This article assumes that your Vault follows the recommendations in Configuring Submission Content Planning. For information about other types of content plans, see Using Report Level Content Plans and Using Global Content Plans.

How Submission Content Planning Works

Content plans are a hierarchical structure of Content Plan records and Content Plan Item records. Content Plan records represent sections and subsections. Content Plan Item records represent individual documents that you intend to collect as part of the submission. Within a single plan, all of these sections and expected documents are descendant records of a single Content Plan record.

When you create a content plan from a submission, Vault can leverage the various relationships that exist between the Submission record and other object records, for example, related Submission Drug Product and Submission Active Substance records. If your template is set up using tokens, some content plan sections or content plan items will repeat for each instance of a specific relationship. For example, the “Clinical Studies Reports” section may repeat for every clinical study linked to the submission. Vault creates repeating sections in alphabetical order.

Country-Specific Module 1

Your plan template may include multiple Module 1 sections, each representing the structure required for a specific country. When you create a plan, Vault reads the Lead Market field on the submission’s related Application record and creates the Module 1 section that corresponds to the correct country.

About Document Matching

Depending on your configuration, Vault may automatically match documents to Content Plan Items (EDL Items). Vault determines matches using field values on the document and Content Plan Item record. Learn more about continuous matching and tracking fields.

Auto-Matching

When the Include Previously Matched Documents submission field is populated (true):

• A single document can auto-match with Content Plan Item records in content plans for multiple submissions related to the same application.
• When a user locks the Content Plan Item record to a specific document version, the same document version can auto-match to a Content Plan Item record for another submission.

Preventing Duplicates

By default, RIM Submissions includes some special matching functionality to prevent multiple submissions from including duplicate documents. When the Include Previously Matched Documents submission field is blank (false):

• A single document can auto-match with multiple Content Plan Item records within a single content plan.
• A single document can auto-match with Content Plan Item records in content plans for multiple submissions if they do not belong to the same application.
• A single document cannot auto-match with Content Plan Item records in content plans for multiple submissions related to the same application. If a user locks the match to a specific document version, subsequent document versions can auto-match to a Content Plan Item record for another submission.

About the Exclude from Auto-Matching Field

In some cases, your organization may want to exclude a content plan section from auto-matching at the template level. This may be useful in specific areas when Content Plan and document matching criteria are too broad, resulting in extraneous sections and documents which must later be removed.

When configured by an Admin, you can select the Exclude from Auto-matching field within the Content Plan Template record. When a content plan is created based on the template, Vault copies the selection to the Content Plan record, excluding it from auto-matching.

Match Document Mode

You can use Match Document Mode in the Content Plan Hierarchy Viewer to manually match and unmatch documents to a Content Plan Item record, then traverse to the next record for matching.

The document picker is prefiltered based on the auto-matching criteria defined for the content plan. The auto-matching criteria are displayed as filters in the document picker, and you can adjust the filters to narrow or expand the list of documents for matching.

Manual Matching

You can also manually match specific documents to Content Plan Items. When you upload a document, create a document from template, or create a document placeholder from a Content Plan Item record in RIM Submissions, Vault immediately matches the document or placeholder to the Content Plan Item record and treats it as a manual match. Your security profile must include the EDL Matching: Edit Document Matches permission in order for Vault to match the document or placeholder to the Content Plan Item automatically.

Creating Content Plans

To create a content plan for a submission:

1. Navigate to an Application record and then to a Submission record within that application.
2. Edit the Submission record as necessary.
3. From the Actions menu, select Create Content Plan. Depending on your Vault’s configuration, the Submission record may need to be in a specific lifecycle state for you to see this action.
4. Select a content plan template from the Plan Template picklist. This determines which template Vault uses when creating your content plan. You can also fill in the Plan Template field when editing the Submission.
5. Vault starts creating the content plan. This process may take a while. When it is complete, you’ll receive a notification.

Updating Content Plans

If a content plan already exists for a submission, you can choose to update the existing content plan. Updating a content plan will create new Content Plan sections and Content Plan Item records based on the Submission record’s relationships and any updates to the template.

Vault creates these new sections and records under the top-level Content Plan record. If the Content Plan Template records use tokens to reflect field values in the content plan names, updating the content plan will also update the record names. Vault orders newly-created sections alphabetically and places them after existing sections. The order of existing sections does not change, even if record names change.

Vault cannot perform the Update Content Plan action while a Split Content Plan Item, Content Plan Hierarchy State Change, or Copy into Content Plan action is running in the same content plan.

You can also move clinical and nonclinical study report sections when you update the applicable clinical or nonclinical Study Type and Study Subtype fields. See Updating Content Plan Study Sections.

How to Update Content Plans

To update a content plan:

1. Navigate to an Application record and then to a Submission record within that application.
2. From the Actions menu, choose Update Content Plan. Depending on your Vault’s configuration, the Submission record may need to be in a specific lifecycle state for you to see this action.
3. Vault starts updating the content plan. This process may take a while. When it is complete, you’ll receive a notification.

Selecting a Different Template

Vault does not support combining templates in a content plan. If you change the template assigned to the Submission record, Vault creates a new content plan hierarchy that matches the newly-selected template, but does not remove the outdated content plan.

To properly create a content plan that matches the new template, you must unlink the Content Plan record from the Submission record, delete the existing content plan, and then use the Create Content Plan action.

Updating Content Plan Study Sections

When configured by an Admin, you can move clinical and nonclinical study report sections with a specified clinical or nonclinical study type and clinical or nonclinical study subtype to a different location within an eCTD submission content plan. To do this, you can update a Submission Clinical Study or Submission Nonclinical Study record’s Study Type and Study Subtype fields, then run the Update Content Plan Study Section action to move them accordingly.

For example, a Submission Clinical Study was originally created in Section 5.3.1.1 of the eCTD content plan with its Clinical Study Type and Clinical Study Subtype values set to Biopharmaceutical and Bioavailability (BA), respectively. During a review, Regina realizes that the clinical study section should be in Section 5.3.1.2 instead of 5.3.1.1. Instead of deleting and re-creating the section, Regina updates the Clinical Study Subtype value on the Submission Clinical Study to Comparative BA and Bioequivalence (BE), then runs the action. Vault processes Regina’s changes via a system job, moving the records to Section 5.3.1.2 (Comparative BA and Bioequivalence (BE) Study Reports).

How to Update Submission Content Plan Study Sections

To update a submission content plan study section:

1. Navigate to an Application record and then to a Submission record within that application.
2. Locate the Submission Clinical Study or Submission Nonclinical Study join record that corresponds to the Content Plan study section you wish to move. If the Submission Wizard is not enabled in the Vault, click Edit and update the clinical or nonclinical Study Type and Study Subtype fields to reflect the appropriate study metadata and determine where the section should be moved. Click Save.
   1. If the Submission Wizard is enabled in your Vault, update the study type or study subtype field values on the Application Clinical or Nonclinical Study relationship record that is referenced as the record’s Application Source.
   2. If the Application Clinical or Nonclinical Study relationship record cannot be updated (because, for example, it has already been submitted in another submission), create a new Application Clinical Study or Application Nonclinical Study relationship record with the new study type and subtype. Then, update the Application Source field on the Submission Clinical Study or Submission Nonclinical Study record to the newly-created Application Clinical or Nonclinical Study record.
3. From the Submission Clinical Study or Submission Nonclinical Study record’s Actions menu, choose Update Content Plan Study Section. The action is available depending on your Vault’s Content Plan object lifecycle configuration.
4. Vault begins updating the content plan. When complete, you’ll receive a notification.

How Vault Updates Submission Content Plan Study Sections

When relocating or reparenting the section, Vault also updates the following fields within the Content Plan and/or its descendant Content Plan Item records:

• Clinical or Nonclinical Study Type
• Clinical or Nonclinical Study Subtype
• Source Content Plan Template
• Source Content Plan Item Template
• Submission Indication
• Indication
• Published Output Location

Additionally, as Vault updates the source Content Plan and Content Plan Item records based on the Name defined in the template, we recommend the equivalent records within each study section are named the same in the template. For example, if a Content Plan Item Template record is named “Protocol” in section 5.3.1.1, it should also be named “Protocol” in section 5.3.1.2. This ensures the Content Plan Item records created based on the template are properly updated during the relocation process.

Automatic Content Plan Creation & Updates

In some configurations, your Vault automatically creates or updates content plans from templates when the Submission record enters a specific lifecycle state.

Copying Content Plans

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 when a new product or annual review needs to be submitted in multiple regions.

For example, you can copy a content plan from an NDA Application submitted in the US, to an MRP Application that needs to be submitted in the EU. With advanced copy, Vault will automatically duplicate the entire content plan and update the plan to reflect the target (EU) application and submission.

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 Submission join records if a matching join record does not already exist on the target submission: Submission Pharmaceutical Product, Submission Active Substance, Submission Inactive Ingredient, Submission Indication, Submission Clinical Study, Submission Nonclinical Study, Submission Country, Submission Language, Submission Pharmaceutical Form. If a matching join record already exists, Vault references that record rather than creating a new one.
• Reruns the content plan template and removes any irrelevant sections or items from the new content plan if the Region and Lead Market Country are different from the source content plan.
• Creates new sections in the new content plan if the target submission contains Submission join records that don’t exist in the source submission; Vault orders new sections alphabetically and places them after existing sections, which retain their original order.
• Creates Inactive records in the copied plan if they were Inactive in the source content plan.
• Creates records that were deleted from the source content plan as Active records in the copied content plan, depending on content plan template constraints.
• Copies the join records onto the application if it doesn’t yet exist on the application, when the Enable Application Relationships flag is enabled in the Vault.

Depending on your Admin’s configuration for the Copy Content Plan workflow, Vault may apply content plan template constraints configured for the target application and submission when you copy a content plan. For example, when you copy a content plan that includes the full Module 5 to a submission with constraints that exclude it, Vault removes Module 5 from the newly-created content plan. After completing the copy, Vault includes details about applied constraints in the CSV file.

Vault creates records that were created or deleted and then recreated due to filtering or constraints in the starting lifecycle state.

How to Copy Content Plans

To copy from an existing content plan:

1. Navigate to an Application record and then to a Submission record within that application.
2. From the Actions menu, choose Copy from Content Plan.
3. Select the desired content plan and dossier format from the Copy From Content Plan and Dossier Format picklists.
4. Click Start. Vault begins copying the 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 copies components.

Copying Content Plan Sections

Using the Content Plan Hierarchy Viewer, you can also 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.

Viewing Content Plans

The Content Plan Hierarchy Viewer helps you easily navigate within a content plan. If the Submission record has a linked content plan, you’ll see the View Tree Layout button. Click it to open your content plan in the viewer.

The Actions menu on the Submission record also provides an option to View Content Plan.

Viewing Matched & Published 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 disable pop-ups in your browser to see the mini-browser window.

Creating a Binder from a Content Plan

You can create a binder directly from a content plan or any child section below it. This action converts the selected content plan section into a binder and its child sections into binder sections, and maps all matching documents to the new binder while maintaining the content plan’s hierarchy and order. When the process is complete, Vault sends a notification containing a link to the new binder. When multiple versions of the same document are included in the same section of the content plan, Vault includes them in the binder and binder exports.

A binder that was previously created from a content plan will be minor up-versioned each consecutive time a user runs the Create Binder from Content Plan action. When a binder is approved, Vault creates a minor up-versioned draft. You cannot up-version archived binders.

Using Cascade Document Version Locking

The Cascade Document Version Locking user action allows you to set version locking for documents matched to Content Plan Item records contained within a content plan section. The available version locking actions depend on your configuration.

How to Set Version Locking on Matched Documents

To set version locking on matched documents:

1. Navigate to a Content Plan record.
2. Click the View Tree Layout button.
3. From the content plan Actions menu, select the available version locking action. The available action depends on your configuration.
4. When version locking is complete, Vault sends you a notification and an email.

Version Locking Actions

Admins can configure the following version locking user actions for your Vault:

Action	Explanation
Remove Version Locking for All Matched Documents	This option returns documents to the unlocked state and matches the newest version of a document to the Content Plan Item record.
Lock All Unlocked Matched Documents to Latest Steady State Version	This option explicitly locks all unlocked documents to the current Steady state version. If no Steady state version exists, documents remain unlocked. This also includes an option to enable Vault to use both the steady state version and the latest lockable version configured as a Lockable Document State in your Vault’s General Settings.
Override Locking on All Matched Documents to Latest Steady State Version	This option explicitly locks all documents to the current Steady state version. If no Steady state version exists, documents remain unlocked. This also includes an option to enable Vault to use both the steady state version and the latest lockable version configured as a Lockable Document State in your Vault’s General Settings.

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.

Splitting Content Plan Items

The Split Content Plan Item user action allows you to create additional content plan items when the number of matched documents on a Content Plan Item record exceeds the number of expected documents. Vault cannot perform this action while an Update Content Plan, Content Plan Hierarchy State Change, or Copy into Content Plan action is running in the same content plan.

How Splitting Content Plan Items Works

When running the Split Content Plan Item action, Vault automatically:

• Creates new Content Plan Item records of the same object type as the source record and distributes the extra matched documents to the new records based on the Expected Steady State Count.
• Inserts new Content Plan Item records below the source Content Plan Item in the hierarchy.
• Excludes the extra matched documents on the source Content Plan Item record to prevent documents that were split from being included in future auto-matching.
• Sets all matched documents on the new Content Plan Item records as manual matches to ensure that the automatic match job doesn’t remove matches when a subsequent Content Plan is created.
• Sorts matched documents alphanumerically if they do not have a predefined order. Otherwise, Vault respects matched document ordering applied in the Content Plan Hierarchy Viewer.
• Clears the Full Document Type field on the new Content Plan Items to prevent any new auto-matches.
• Resolves tokens in the Name, XML Title, and Published Output Location fields on the source and newly created Content Plan Item records.
• Runs an on-demand publishing job on the parent Content Plan record after the action is complete (in Vaults with continuous publishing enabled).

To resolve tokens, Vault first looks at the values defined in the Content Plan Template configuration. If the Content Plan Template record doesn’t contain tokens in these fields, Vault checks for tokens on the source Content Plan Item record. Vault copies all other field values from the source Content Plan Item record as well. Vault only resolves matched document tokens when there is a single matched document on the Content Plan Item record.

How to Split Content Plan Items

To split content plan items, navigate to the Content Plan Item record and select Split Content Plan Item from the Actions menu. This action is available when:

• The All Document Count on the Content Plan Item is greater than the Expected Steady State Count.
• The Expected Steady State Count is greater than zero (0).

Vault performs validation when you select the Split Content Plan Item action. When the job is complete, Vault sends you a notification and email reporting successes or failures. If the source Content Plan Item record contains unique required fields that Vault can’t resolve on the new Content Plan Item records, the action fails.

After splitting content plan items, you should not add the excluded documents back to the original Content Plan Item record manually.

Required Permissions

To split content plan items, you require the following permissions:

• Your permission set must provide the ability to Create and Edit the Content Plan Item object and its applicable object types.
• Your permission set must provide the ability to Edit Match Fields and Edit Document Matches, as configured within the Application tab under EDL Matching.
• Your Vault’s Content Plan Item lifecycle must allow a user in your role to Edit the following Content Plan Item fields: Name, XML Title, and Published Output Location.
• Your Vault’s document security must allow you to View any document matched to the source Content Plan Item.

Example: Case Report Forms

When assembling a Clinical Study Report, users must include a Case Report Form (CRF) for each Serious Adverse Event (SAE), such as death, as well as for each withdrawal for an Adverse Event (AE). Since the number of Adverse Events that occur within a study can’t be predicted, users need to be able to place many CRFs into a content plan without having to manually create Content Plan Items for each CRF. It also isn’t feasible for Admins to create content plan templates with thousands of Content Plan Items, as there is always a chance that a study will require more or less.

With the Split Content Plan Items user action, a user can upload as many CRFs as needed to a single Content Plan Item, and then split that Content Plan Item to create individual Content Plan Items for each CRF.

Using Update Tokens in Field(s)

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.

Vault only resolves matched document tokens based on the first matched document on the Content Plan Item, regardless of the number of matched documents. Both actions also update Submission and Report Level Content Plan tokens on the Content Plan Item.

How to Update Tokens

To update unresolved tokens on multiple Content Plan Items under a Content Plan, navigate to the Content Plan object record and select Update Tokens in Fields from the Actions menu. You’ll receive a notification with a results log file 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.

Merging & Publishing Content Plans & Items

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.

About Content Plan Record Creation

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.

Notifications & Error Logs

When Vault finishes creating or updating a content plan, you’ll receive an email and a Vault notification. The notification includes a link to the content plan and summary of successful and failed steps.

If any steps failed, you can click the number to download a log explaining the errors.