# Using Report Level Content Plans (RIM)

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 <a href="/en/gr/37472/">Using Submission Content Plans</a>.

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      <p><strong>Note</strong>: This feature is only available on RIM Submissions Vaults.</p>
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## 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 <a href="/en/gr/15303/">Vault annotation links</a> 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][3].

## Creating & Updating Report Level Content Plans

To create report level content plans:

  1. Navigate to a _Clinical Study_, _Nonclinical Study_, or _Product Family_ (`product__v`) record.
  2. Expand the **Study Report** or **Product Family Report** section and click **Add**.
  3. Click **Create** to create a new report. In the dialog, populate and save the report's details. You can also add an existing report.
  4. Click **Save**.
  5. Click **Ok** to add the created record.
  6. From the newly-created record's **Actions** menu, click **Create Content Plan**. This action may have a different name in your Vault.
  7. 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.

### Updating Tokens

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.

## Copying Content Plans {#copying-rlcp}

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.



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      <p><strong>Note</strong>: An Admin must enable this feature by configuring an object workflow for the <em>Report Level Content Plan</em> object and adding the <em>Copy Content Plan</em> 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 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:
  1. Navigate to a _Clinical Study_, _Nonclinical Study_, or _Product Family_ record and create a _Report Level Content Plan_ record from the Study Reports section.
  2. From the **Actions** menu of the _Report Level Content Plan_ created in Step 1, choose the appropriate copy action, for example **Copy Report**. Depending on your Vault's configuration, there may be options to **Copy Clinical Study Report** or **Copy Nonclinical Study Report**.
  3. Select the desired report level content plan whose content plan you want to copy from the **Copy Content Plan** picklist.
  4. 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 <a href="/en/gr/59502/#copy-section">Using the Content Plan Hierarchy Viewer</a> for more information.

## Dynamic Linking {#dynamic-linking}

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 <a href="/en/gr/57859/">Using Dynamic Linking</a> for more information.

## Using a Table of Contents {#using-a-toc}

To allow Vault to generate a Table of Contents (TOC) document:

1. Open the appropriate _Content Plan Item_ record.
2. Set the **Node Type** (`xml_node_type__v`) field to **Table of Contents**.
3. In the **Publishing Element** field, select the TOC template.
4. Select the **Full Document Type**.
5. 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 <a href="/en/gr/48602/#toc-setup">configured</a> the TOC to use sequential page numbering, Vault uses zero (0) as a placeholder for page numbers in the generated TOC. For example, when the total number of pages is 1,000, the placeholder page number will be "0000000." Vault replaces these placeholders when merging the published content plan into a single PDF. See details about [document merging][7] 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 <a href="/en/gr/68676/">Content Plan Lifecycle State Changes</a> for details about these options.

## Publishing Documents

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 <a href="/en/gr/23145/">CrossLink document</a> 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:

  1. Navigate to the root _Content Plan_ record.
  2. 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][7] below.
  3. 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.

## Merging & Publishing Content Plans & Items {#merged-documents}

When <a href="/en/gr/45365/#merge-and-publish">configured by an Admin</a>, 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 <a href="/en/gr/374721/">Merging & Publishing Content Plans & Items</a> for more information.

## Publishing Details

After you publish a report, you can access published documents and document details by navigating to the desired content plan in the <a href="/en/gr/59502/">Content Plan Hierarchy Viewer</a>. 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 <a href="/en/gr/23145/">CrossLinks documents</a>.
  * During publishing, Vault renders all links to display in blue text, even if <a href="/en/gr/153330/#link-settings">this setting</a> 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.

### Overlay Publishing

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.

## Validation Details

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 <a href="/en/gr/58742/">Working with Submission Validation Results</a> for complete details about validation results.

## Viewing Report Level Content Plans {#viewing-rlcps}

The <a href="/en/gr/59502/">Content Plan Hierarchy Viewer</a> 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 <a href="/en/gr/67459/">Viewing Publishing Progress</a> 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.

## Exporting the Submission Ready Binder {#exporting}

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.

## Related Permissions

The following permissions control your options for report level content plans:

|Type|Permission Label|Controls|
|--- |--- |--- |
|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.|

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        <a id="footnote"></a>*In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices:
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          The <em>Product</em> (<code>product__v</code>) object is now <em>Product Family</em>.
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          The <em>Drug Product</em> (<code>drug_product__v</code>) object is now <em>Product</em>.
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          The <em>Product Detail</em> (<code>product_detail__v</code>) object is now <em>Product Variant</em>.
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      <p class="p1">
        In existing Vaults, Admins can <a href="/en/gr/15057/#customizestandardobjects">update these objects manually</a>.
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 [3]: #exporting
 [7]: #merged-documents