Configuring Report Level Content Plans (RIM)

Report level content plans let users compile and publish documents for Clinical Study Reports and Nonclinical Study Reports. Users can also create non-study specific reports related to a Product Family*, such as Periodic Safety Reports and Investigator’s Brochures.

This feature leverages content plans to collect the documents and report structure in the pre-publishing process and supports managing and publishing document reports in Vault that may later become part of submissions to the Health Authority. For information about configuring submission content plans, see Configuring Submission Content Plans.

Note: This feature is only available on RIM Submissions Vaults.

Configuration Components

In addition to the submission content plan components, RIM Submissions Vaults include the following components to support report level content plans:

Objects

The Report Level Content Plan object allows you to configure content plans for the assembly of clinical study, nonclinical study, and product family document reports based on specific object types and join records. The Report Level Plan Clinical Study, Report Level Plan Nonclinical Study, and Report Level Plan Product Family join objects pair the Report Level Content Plan object with the Clinical Study, Nonclinical Study, and Product Family* objects, respectively.

Object Types

The Report Level Content Plan object has Clinical Study, Nonclinical Study, and Report object types enabled automatically. These object types determine the type of content plan users can create.

The following object types are available on all content plan objects (Content Plan, Content Plan Template, Content Plan Item, and Content Plan Item Template):

Report Level Plan Clinical Study
Report Level Plan Nonclinical Study
Report

Object Page Layouts

The Report Level Content Plan object has custom page layout sections for Clinical Study Report, Nonclinical Study Report, and Product Family*. You can configure the Report Level Plan Clinical Study, Report Level Plan Nonclinical Study, and Report Level Plan Product Family sections for the Clinical Study, Nonclinical Study, and Product Family* object page layouts, respectively.

Associated Object Fields

The following object fields appear on content plan objects (Content Plan, Content Plan Template, Content Plan Item, and Content Plan Item Template) to help users manage and publish report level content plans:

Field	Object	Function
Report Level Content Plan	Content Plan	This field associates the Report Level Content Plan record with the content plan.
Report Level Plan Clinical Study	Content Plan	This field is automatically populated on content plan creation when specifying the `${report_level_clinical study__v}` token in the Content Plan Template Name field and is based on the Report Level Plan Clinical Study join record associated with the report level content plan.
Report Level Plan Non Clinical Study	Content Plan	This field is automatically populated on content plan creation when specifying the `${report_level_nonclinical study__v}` token in the Content Plan Template Name field and is based on the Report Level Plan Nonclinical Study join record associated with the report level content plan.
Report Level Plan Product Family	Content Plan	This field is automatically populated on content plan creation when specifying the `${report_level_plan_product_family__v`} token in the Content Plan Template Name field and is based on the Report Level Plan Product Family join record associated with the report level content plan.
Product Family*	Content Plan	This field references a single or primary Product Family* with which a content plan is associated.
Related Submissions Binder	Content Plan	Vault populates this field on the root Content Plan record with a link to the published binder.
Include eSignatures	Content Plan Item	This field determines whether to include the eSignature from the source document in the published output. By default, the eSignature is not included.
Report Level Content Plan	Content Plan Item	Report Level Content Plan record associated with the Content Plan Item. This is a lookup field to the Content Plan Item's parent Content Plan record.
Report Level Plan Clinical Study	Content Plan Item	This is a lookup field to the Content Plan Item's parent Content Plan record.
Report Level Plan Non Clinical Study	Content Plan Item	This is a lookup field to the Content Plan Item's parent Content Plan record.
Report Level Plan Product Family	Content Plan Item	This is a lookup field to the Content Plan Item's parent Content Plan record.
Product Family*	Content Plan Item	This is a lookup field to the Content Plan section Primary Product Family field. This field corresponds to the document's Product Family* field and may be used for auto-matching.
Published Output Location	Content Plan Item	This field defines the folder path and filename where the published document resides in the output. Value is defaulted by concatenating the Folder Path field of the Content Plan Template and the Filename field of the Content Plan Item Template. Note: The Published Output Location field has a 100-character limit. If it exceeds the character limit, Vault cannot publish or publish/merge.
Published Document	Content Plan Item	Vault populates this field with a link to the published document based on the matched document.
Source for Published Document	Content Plan Item	This field defines the rendition used as the source for the published document. Value defaults from the corresponding field on Content Plan Item Template.
Open Validation Results	Content Plan Item	This field provides the count of open validation failures for the associated Content Plan Item.
Filename	Content Plan Item Template	This field is used to default the filename in the Published Output Location field on the Content Plan Item record. Vault uses this field to name the resulting published output.
Folder Path	Content Plan Template	This field is used to default the folder path in the Published Output Location field on the Content Plan Item record. Vault uses this field to create the folder structure in the resulting published output.
Published Content Owner	Report Level Content Plan	This field defines the owner of the published documents. If blank, the owner of the published documents matches the owner of the source document.

Configuration Overview

To set up report level content plans, complete the following steps:

Enable the report level content plan object types on content plan objects. Ensure the relevant fields from the table above are appropriately configured on the object types.
Set up constraints for the Content Plan Template field on the applicable Report Level Content Plan object type. For example, only allow users to select the Clinical Study Report Template in the Content Plan Template field on the Report Level Plan Clinical Study object type.
Configure object page layouts to allow users to easily add the related Report Level Content Plan section to the Clinical Study, Nonclinical Study, and Product Family* objects. For example, you could name sections Study Reports or Complex Reports.
Set up actions on the Report Level Content Plan object lifecycle to allow users to create or update the related content plan.
Optional: Configure additional system actions, entry actions, entry criteria, and user actions on the Content Plan, Content Plan Item, or Report Level Content Plan object lifecycles to fit your organization’s business processes.
Create content plan templates using the Content Plan Template and Content Plan Item Template objects.
Optional: Enable continuous matching to allow Vault to match documents to Content Plan Item records automatically based on matching criteria. Learn about configuring document matching in EDL Administration.
Optional: Update the Progress Icon formula field on the Content Plan Item object to display different status icons. See About the Progress Icon Field for details.
Optional: Configure the Content Plan Hierarchy Viewer to allow users to drag and drop to copy and reuse content plan sections.
Optional: Configure a workflow for the Report Level Content Plan object lifecycle to allow users to copy from an existing content plan.
Optional: Add the Content Plan button to the Report Level Content Plan object record detail page.
Optional: Configure Atomic Security to secure RIM standard actions within an object lifecycle based on the state of the record and the user’s assigned role. See Configuring Atomic Security for Content Plan Actions for details.
Recommended: Enable the Delete Inactive Content Plans job to delete unused, inactive Content Plan and Content Plan Item records, reducing the number of unnecessary records which can cause performance issues in some Vaults. See RIM Submissions Overview for more information.

Enabling Object Types

Enable the Report Level Plan Clinical Study, Report Level Plan Nonclinical Study, and Report object types on all content plan objects (Content Plan, Content Plan Template, Content Plan Item, and Content Plan Item Template). You’ll also need to set the Report object type to Active on the Report Level Content Plan object.

If you haven’t enabled object types on the content plan objects prior to configuring report level content plans, you’ll need to enable them and create Report Level Plan Clinical Study, Report Level Plan Nonclinical Study, and Report object types.

Configuring Constraints

Set up constraints for the Content Plan Template field on the applicable Report Level Content Plan object type. This allows you to define filters on the Content Plan Template field to only display content plan templates related to clinical and nonclinical study reports or product families.

To configure a Clinical Study Report constraint:

Navigate to Admin > Configuration > Objects > Report Level Content Plan > Object Types > Clinical Study Report > Content Plan Template.
From the Content Plan Template details page, click Edit.
Scroll down to the Constrain Records in Referenced Object section and set the Criteria VQL field to: parent__v = null AND object_type__vr.name__v = 'Report Level Plan Clinical Study'. The object_type__vr.name__v must reflect the Report Level Plan Clinical Study object type label on the Content Plan object.
Optional: Click Validate to confirm if your criteria VQL is valid.
Optional: Click Preview to see how field selection will look once your filter rule is in place.
Click Save.

Repeat this step for both the Nonclinical Study Report and the Report object types using the following Criteria VQL:

Nonclinical Study Report: parent__v = null AND object_type__vr.name__v = 'Report Level Plan Nonclinical Study'
Study: parent__v = null AND object_type__vr.name__v = 'Report'

Updating Object Page Layouts

Configure page layouts to allow users to easily add reports to the Clinical Study, Nonclinical Study, and Product Family* objects. Users can create one or more report level content plans per study or product family, for example, when different reports are needed for different regions.

To update the Clinical Study object page layout:

Navigate to Admin > Configuration > Objects > Clinical Study > Page Layouts > Clinical Study Detail Page Layout.
From the page editor, click Create Section.
Select Related Object to open up the Add Related Object Section dialog.
Select Report Level Plan Clinical Study > Report Level Content Plan from the Related Object picklist.
Select Clinical Study Report from the Limit Related Records to these Object Types picklist.
Enter Study Reports in the Section Label field.
Click Done.
Click Save.

Repeat this step for the Nonclinical Study and Product Family* objects, adding related object sections for the Report Level Plan Nonclinical Study > Report Level Content Plan and Report Level Plan Product Family > Report Level Content Plan objects, respectively.

Configuring the Report Level Content Plan Object Lifecycle

If your Vault doesn’t have a Report Level Content Plan object lifecycle, you must create one and associate it with the Report Level Content Plan object. Then, you can set up actions to allow users to create a related content plan. There are two ways to do this, both using the Create Content Plan action:

As a system action in a workflow
As a lifecycle state entry action

In both cases, you also need to create user actions on the appropriate states to move the Report Level Content Plan record into a new state or to initiate a workflow on the Report Level Content Plan record. You can set up the user action on the Active state or, if needed, create a custom state.

Managing Report Level Content Plans with a Lifecycle

When managing Content Plan, Content Plan Item, and Report Level Content Plan records with lifecycles, you can define additional lifecycle state user actions, entry actions, entry criteria, or workflow system actions to allow users to perform various actions on content plans. See Managing Content Plans with a Lifecycle for more information.

Creating Content Plan Templates

Content plan templates define the structure and hierarchy when users create new content plans. Create content plan templates based on the report structure, for example, Clinical Study Report and Nonclinical Study Report, and associate them to the corresponding object types. This allows users to create report level content plans for clinical and nonclinical study reports.

You can also create Content Plan Templates for reports that would be associated to the Product Family* object, such as Pharmacovigilance reports or Investigator’s Brochures.

Configuring the Content Plan Hierarchy Viewer

The Content Plan Hierarchy Viewer is automatically available in your Vault, with additional configuration options such as allowing users to copy individual content plan sections via drag and drop, or copy the entire structure of a report level content plan.

Content Plan Drag & Drop Copy

When configured, users can drag and drop a Content Plan or Content Plan Item row in the Content Plan Hierarchy Viewer to copy that section from an existing content plan into the current content plan.

To configure drag and drop copy:

If not already configured, add and activate the Create Sibling record action on both the Content Plan and Content Plan Item objects, and the Create Child record action on the Content Plan Item object.
Review and update your Vault’s Action Level Security configuration for the Create Sibling and Create Child record actions to ensure the required user roles are able to Execute the action in the desired Content Plan and Content Plan Item object lifecycle states.

Content Plan Advanced Copy

You can configure a workflow using the Copy Content Plan system action to allow users to create a content plan for a report level content plan by copying the entire structure of another report level content plan. See Managing Content Plans with a Lifecycle for more information.

Enabling the Content Plan Button

Users can open a content plan in the Content Plan Hierarchy Viewer directly from an object record detail page by clicking the Content Plan button. This button is automatically available on the Content Plan object. You can also add or remove this button on the Report Level Content Plan object record detail page for each Report Level Content Plan object type:

Navigate to Admin > Configuration > Objects > Report Level Content Plan > Object Types.
Click the Actions link to toggle from the Fields view to the Actions view.
Open the Actions menu and select Edit Object Type Actions.
In the Content Plan row, select the checkbox for each object type on which you want to enable this button. If you want to remove this button for an object type, clear the checkbox.
Click Save.

Report Level Publishing Configuration

Once users have matched documents and finalized a content plan, you can allow them to publish that content plan. See Configuring Report Level Publishing for detailed instructions.

You must have the following permissions to set up report level content plans:

Type	Permission Label	Controls
Security Profile	Object: Content Plan	Ability to create and edit records; this may not be necessary for the users creating the template, but is necessary to create content plans from templates.
Security Profile	Object: Content Plan Item	Ability to create and edit records; this may not be necessary for the users creating the template, but is necessary to create content plans from templates.
Security Profile	Object: Content Plan Item Template	Ability to create and edit records; this is necessary to create templates, but not to create content plans from them.
Security Profile	Object: Content Plan Template	Ability to create and edit records; this is necessary to create templates, but not to create content plans from them.
Security Profile	Object: Report Level Content Plan	Ability to create and edit records; users need this to select a content template and create the content plan.
Security Profile	Object: Report Level Plan Clinical Study	Ability to create the record and associate a Clinical Study to the Report Level Content Plan object.
Security Profile	Object: Report Level Plan Nonclinical Study	Ability to create the record and associate a Nonclinical Study to the Report Level Content Plan object.
Security Profile	Object: Report Level Plan Product Family	Ability to create the record and associate a Product Family (`product__v`) to the Report Level Content Plan object.
Security Profile	Admin: Object Lifecycles	Ability to modify object lifecycles. Admins need this to set up the lifecycle state user actions required for Report Level Content Plans.
Security Profile	Admin: Object Workflows	Ability to modify object workflows. Admins need this access to set up workflows that move a Report Level Content Plan record to a new state.

*In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices:

The Product (product__v) object is now Product Family.
The Drug Product (drug_product__v) object is now Product.
The Product Detail (product_detail__v) object is now Product Variant.

In existing Vaults, Admins can update these objects manually.