|
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.
|
|
Output Document Type
|
Report Level Content Plan
|
This field defines the document type for the published Report Level Content Plan content.
|
|
RLCP Section Output Document Type
|
Content Plan
|
This field defines the document type for the published Report Level Content Plan using section level merge.
|
|
Published Links Opening Setting
|
Report Level Content Plan
|
This field defines whether to open external document hyperlinks in a new window, or whether published hyperlinks are opened per the user preference.
|
## Configuration Overview
To set up report level content plans, complete the following steps:
1. Enable the [report level content plan object types][4] on content plan objects. Ensure the relevant fields from the table above are appropriately configured on the object types.
2. Set up [constraints][5] 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.
3. Configure [object page layouts][6] to allow users to easily add the related Report Level Content Plan section to the _Clinical Study_, _Nonclinical Study_, and _Product Family_[*][1] objects. For example, you could name sections _Study Reports_ or _Complex Reports_.
4. Set up actions on the [_Report Level Content Plan_ object lifecycle][7] to allow users to create or update the related content plan.
5. Optional: Configure additional [system actions, entry actions, entry criteria, and user actions][8] on the _Content Plan_, _Content Plan Item_, or _Report Level Content Plan_ object lifecycles to fit your organization's business processes.
6. Create [content plan templates][9] using the _Content Plan Template_ and _Content Plan Item Template_ objects.
7. 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](/en/lr/33316/#automatic-document-matching).
8. Optional: Update the _Progress Icon_ formula field on the _Content Plan Item_ object to display different status icons. See [About the Progress Icon Field](/en/lr/64518/ ) for details.
9. Optional: Configure the [Content Plan Hierarchy Viewer][12] to allow users to drag and drop to copy and reuse content plan sections.
10. Optional: Configure a workflow for the [_Report Level Content Plan_][22] object lifecycle to allow users to copy from an existing content plan.
11. Optional: Add the [**Content Plan** button][13] to the _Report Level Content Plan_ object record detail page.
12. 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](/en/lr/68399/ ) for details.
13. 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](/en/lr/30704/#delete-inactive-content-plans) for more information.
## Enabling Object Types {#object-types}
Enable the _Report Level Plan Clinical Study_, _Report Level Plan Nonclinical Study_, and _Report_ [object types](/en/lr/32857/#enable) 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](/en/lr/32857/#create) _Report Level Plan Clinical Study_, _Report Level Plan Nonclinical Study_, and _Report_ object types.
## Configuring Constraints {#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:
1. Navigate to **Admin > Configuration > Objects > Report Level Content Plan > Object Types > Clinical Study Report > Content Plan Template**.
2. From the **Content Plan Template** details page, click **Edit.**
3. 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.
4. Optional: Click **Validate** to confirm if your criteria VQL is valid.
5. Optional: Click **Preview** to see how field selection will look once your filter rule is in place.
6. 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 {#page-layouts}
Configure page layouts to allow users to easily add reports to the _Clinical Study_, _Nonclinical Study_, and _Product Family_[*][1] 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:
1. Navigate to **Admin > Configuration > Objects > Clinical Study > Page Layouts > Clinical Study Detail Page Layout**.
2. From the page editor, click **Create Section**.
3. Select **Related Object** to open up the **Add Related Object Section** dialog.
4. Select **Report Level Plan Clinical Study > Report Level Content Plan** from the **Related Object** picklist.
5. Select **Clinical Study Report** from the **Limit Related Records to these Object Types** picklist.
6. Enter **Study Reports** in the **Section Label** field.
7. Click **Done**.
8. Click **Save**.
Repeat this step for the _Nonclinical Study_ and _Product Family[*][1]_ 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 {#rlcp-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 {#lifecycle-actions}
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](/en/lr/45365/) for more information.
## Creating Content Plan Templates {#templates}
Content plan templates define the structure and hierarchy when users create new content plans. Create [content plan templates](/en/lr/61032/ ) 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_[*][1] object, such as Pharmacovigilance reports or Investigator's Brochures.
## Configuring the Content Plan Hierarchy Viewer {#enable-viewer}
The [Content Plan Hierarchy Viewer](/en/lr/59502/ ) 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:
1. If not already configured, [add and activate](/en/lr/43127/#assign-actions) 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.
2. Review and update your Vault's [Action Level Security](/en/lr/43127/#ALS_profile_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](/en/lr/45365/#content-plan-copy) 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:
1. Navigate to **Admin > Configuration > Objects > Report Level Content Plan > Object Types**.
2. Click the **Actions** link to toggle from the _Fields_ view to the _Actions_ view.
3. Open the **Actions** menu and select **Edit Object Type Actions**.
4. 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.
5. 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](/en/lr/64522/ ) for detailed instructions.
## Related Permissions
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.|