# 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](/en/lr/37474/). For information about other types of content plans, see [Using Report Level Content Plans](/en/lr/47965/) and [Using Global Content Plans](/en/lr/77852/).

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      <p><strong>Note</strong>: This feature is only available on RIM Submissions Vaults. You cannot disable the feature.</p>
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## 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](/en/lr/32749/#continuous).

### 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 {#match_functionality}

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](/en/lr/37474/#about-exclude-from-auto-matching), 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.

### Auto-Matching RLCP Documents

You can select a Report Level Content Plan for each clinical study and/or nonclinical study in your submissions to further filter documents that match into Modules 4 & 5 of the CTD Submission Content Plan.

The **Report Level Content Plan** field on the Submission Clinical Study and Submission Nonclinical Study objects is used to select a related Report Level Content Plan when creating Submission Clinical or Nonclinical Studies. Vault uses the field to match documents published from the selected Report Level Content Plan to the corresponding Module 4 & 5 Submission Content Plan Items.

### Match Document Mode

You can use [Match Document Mode](/en/lr/59502/#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_](/en/lr/32749/#manual). 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][11].

### 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.

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      <p><strong>Note</strong>: In your Vault’s configuration, the <em>Submission</em> record may need to be in a specific lifecycle state for you to see the <strong>Update Content Plan</strong> action.</p>
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### 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 {#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](/en/lr/45365/#updating-content-plan-study-sections).
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 {#copy-from-content-plan}

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.

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      <p><strong>Note</strong>: An Admin must enable this feature by configuring an object workflow for the <em>Submission</em> object and adding the <strong>Copy Content Plan</strong> system action to the workflow.</p>
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### 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.
  * Copies relationships that are used for content planning onto the target _Submission_ and _Application_ records and corresponding sections added to the target _Submission Content Plan_. 
    * If the _Use for Content Planning_ field is not configured or is set to _No_, the referenced relationship and its corresponding section(s) is excluded. If the _Use for Content Planning_ field is set to _Yes_ or is blank, the relationship is included in the target _Submission_. 
  * Reruns the content plan template and removes any irrelevant sections or items from the new content plan. A section or item is removed when the target content plan submission's _Ad Promo Scope_, _Region_ and _Lead Market Country_ fields do not match the corresponding fields in the source content plan submission.
  * 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.
  * Respects the DTD/XSD Version.

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](/en/lr/46496/) 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 copy's 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](/en/lr/59502/) for more information.

## Viewing Content Plans

The [Content Plan Hierarchy Viewer](/en/lr/59502/) 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 {#creating-a-binder}

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.

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## Using Cascade Document Version Locking {#cascade-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][9]. The available action depends on your configuration.
  4. When version locking is complete, Vault sends you a notification and an email.

### Version Locking Actions {#version-locking-action}

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](/en/lr/68676/) for details about these options.

## Splitting Content Plan Items {#split-content-plan-item}

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.

You can also use **Split Content Plan Item** in [Match Document Mode](/en/lr/59502/#match-document-mode).

### 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 alphabetically if they do not have a predefined order. Otherwise, Vault respects matched document ordering applied in the [Content Plan Hierarchy Viewer](/en/lr/59502/).
  * 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](/en/lr/48608/#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.

### About Normalization

Vault normalizes or updates invalid characters and formatting in order to resolve tokens.

When normalizing the *Published Output Location*, Vault:

* Removes all special characters, including tilde (`~`), backslash (`\`), colon (`:`), asterisk (`*`), question mark (`?`), single quote (`'`), double quote(`"`), less than (`<`), greater than (`>`), pipe (`|`), and space( ).
* Replaces multiple hyphens (for example, `---`) with a single hyphen (`-`).
* Updates all text to lowercase.

## Merging & Publishing Content Plans & Items {#merge-and-publish}

When [configured by an Admin](/en/lr/45365/#merge-and-publish), 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](/en/lr/374721/) 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.

 [9]: #version-locking-action
 [10]: #about-validation
 [11]: #updating-content-plan-study-sections