With submission content plans, users can quickly create a hierarchy that represents the structure of the submission for planning, tracking, and publishing. The hierarchy is also used to collect all the documents in the submission. The content plan structure, and the type and number of expected documents, can vary between submissions. This may also vary based on the related application’s Region and Lead Market country. For information about configuring other types of content plans, see Configuring Report Level Content Plans and Configuring Global Content Plans.
Note: This is only available on RIM Submissions Vaults.
Content Plans & EDLs
Submission content plans use the Expected Document Lists (EDLs) feature and the EDL, EDL Item, EDL Template, and EDL Template Item objects. These objects and relevant fields within are labeled in RIM Vaults as follows. All Vault Help articles for RIM use the “Content Plan” naming.
Content Plan Object Labels
EDL objects are labeled in RIM for content plans as follows:
| EDL Label & Name | Content Plan Label |
|---|---|
| EDL ( edl__v) |
Content Plan |
| EDL Item ( edl_item__v) |
Content Plan Item |
| EDL Template ( edl_template__v) |
Content Plan Template |
| EDL Item Template ( edl_item_template__v) |
Content Plan Item Template |
Content Plan Object Field Labels
EDL object fields are labeled in RIM for content plans as follows:
| EDL Label & Name | Content Plan Label |
|---|---|
| Matching EDL Item Fields ( matching_fields__v) |
Matching Item Fields |
| Source EDL Template ( source_edl_template__v) |
Source Content Plan Template |
| Source EDL Item Template ( source_edl_item_template__v) |
Source Content Plan Item Template |
| RLCP Output Document Type ( rlcp_output_document_type__v) |
RLCP Output Document Type |
| Merge Section ( merge_section__v) |
Merge Section |
| Section Merge Published Output Location ( section_merge_pol__v) |
Section Merge Published Output Location |
| Merged Document ( merged_document__v) |
Merged Document |
| Merged Document (unbound) ( merged_document_unbound__v) |
Merged Document (unbound) |
Additional Terminology
When talking about content plans, we often use “section” and “subsection” to refer to the level of relationships between Content Plan or Content Plan Template records. These terms don’t appear in Vault, but refer to the hierarchical structure of parent and child Content Plan records.
Content Plan Components
The following components support submission content plans:
- The Parent (
parent__v) field on the Content Plan and Content Plan Template objects allow you to create a content plan with self-referencing “child” content plans. - Object lifecycle system actions, entry actions, entry criteria, and user actions allow users to create and work with content plans in various ways.
- Tokens, applied to the Name field within your Content Plan Template hierarchies, allow you to define auto-naming or create sections (child-level Content Plan records) or expected documents (Content Plan Item records) that repeat based on the submission’s relationships.
- The Content Plan Hierarchy Viewer shows content plans and content plan templates in a way that represents the hierarchy.
- The Export Excel Tree with All Descendants action, available from the Content Plan Hierarchy Viewer, allows you to export the content plan hierarchy.
Configuration Overview
To set up submission content plans, complete the following steps:
- Set up custom tabs for the Content Plans object and the Content Plan Templates object to give access to users outside of the Admin area.
- Set up actions on the Submission 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 Submission, Content Plan, or Content Plan Item object lifecycles to fit your organization’s business processes.
- Create content plan templates using the Content Plan Template and Content Plan Item Template objects, tokens, and constraints.
- Set up document matching by configuring document matching fields and enabling the automatic matching job. Learn about configuring document matching in EDL Administration. There are limitations and considerations when deactivating the automatic matching job; see About the Match EDL Items to Documents Job for details.
- Optional: Configure the Exclude from Auto-matching field to prevent auto-matching on individual Content Plan and Content Plan Template records.
- Optional: Configure the Include Previously Matched Documents field to allow a content plan to include documents that previously were matched to another submission within the same application.
- Optional: Add the Use for Content Planning field to various object page layouts to allow users to indicate that Vault should ignore specific object records related to the Submission record when creating content plans.
- 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: Add the Content Plan button to the Submission 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.
- Optional: To create content plans based on the XML version, update the below object page layouts to include the XML ICH DTD / XSD Version and XML Regional DTD / XSD Version fields. Vault supports these fields for the following object types of the Content Plan, Content Plan Item, Content Plan Template, and Content Plan Item Template objects:
- Regional (Module 1)
- Summary (Module 2)
- Quality (Module 3)
- Nonclinical (Module 4)
- Clinical (Module 5)
- Other
Note: You should not add more than three custom relationships when configuring the Content Plan and Content Plan Item objects to protect against database limitations.
Setting Up Custom Tabs
Set up custom tabs for the Content Plans object and the Content Plan Templates object. On each tab, create a saved view that filters on Parent is blank. Since Content Plan and Content Plan Template records use self-referencing relationships to create a hierarchy, this provides a way to quickly filter for the top-level plans, rather than every section and subsection.
We also recommend saving views that filter on Content Plan Type to bookmark submission content plans, clinical study reports, nonclinical study reports, and product family study reports.
Managing Submission Content Plans with a Lifecycle
When managing Submission, Content Plan, and Content Plan Item records with a lifecycle, you can set up actions for the Submission object 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 actions on the appropriate states to move the Submission record into a new state or to initiate a workflow on the Submission record.
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. You create content plan templates using the Content Plan Template and Content Plan Item Template objects.
You can also set up content plan filtering by configuring content plan templates based on Region, Lead Market, Application Type, Submission Type, Submission Subtype, and Supplemental Effective Date Type. This allows you to create more contextual content plans for end users by skipping creation of irrelevant sections or creating these sections in the Inactive status, which is an alternative to creating multiple content plan templates for each combination.
Document Matching Configuration
About the Match EDL Items to Documents Job
Note: The Match EDL Items to Documents job links Content Plan Item records to documents based on matching field values. We recommend the job remains Active in RIM Submissions Vaults in order to properly update the Publishing Status icon and document count and completeness fields.
To disable auto-matching in your Vault:
- Remove any lifecycle state entry actions controlling the behavior of the Match Documents (
batch_update__v) field within the Content Plan object. - Ensure the Match Documents field within all Content Plan records in the Vault are set to “No” (false) or are blank.
- Optional: Remove the Match Documents field from the Content Plan and Content Plan Item object page layouts.
- Set the Match EDL Items to Documents job status to Inactive.
About the Include Previously Matched Documents Field
In some cases, you may want Vault to allow a submission content plan to include documents that have previously matched to another submission within the same application. This may be necessary when you need to include a document previously matched to an inactive content plan in the same application, re-register for an expiring license, resubmit a rejected submission, or reference an already-matched document in an annual report.
To allow document auto-matching with Content Plan Item records for multiple submissions related to the same application, set the Include Previously Matched Documents field to Yes on the Submission record in which you want to include already-matched documents. When the field is blank or set to the default value of No, Vault adheres to the matching functionality which prevents multiple submissions from including duplicate documents.
Note: When you set the Include Previously Matched Documents to Yes, users may not see results immediately. If the Match EDL Items to Documents job has already run, updating this field may not impact the results until the next time the job runs.
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 documents which must later be removed.
When configured on the Content Plan and Content Plan Template objects, Admins can select the Exclude from Auto-matching field on 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.
To set this up:
- Add a condition to the entry action on the Content Plan lifecycle’s Baselined state that sets the Match Documents (
batch_update__v) field to True only when the Exclude from Auto-matching field is False. This will turn on auto-matching only for Content Plan records where Exclude from Auto-matching is not selected. - Optional: Add the Exclude from Auto-matching field to the Content Plan and Content Plan Template object page layouts, as well as the page layouts of any applicable object types.
About the Use for Content Planning Field
In some situations, you may want Vault to ignore certain records related to the submission when creating content plans. For example, when registering a complex product, you could need the Submission Product to populate the registrations, but not the content plan. Similarly, you could need multiple drug strengths on a registration, but not in the content plan.
Users can indicate that Vault should ignore specific records by setting the Use for Content Planning field to No on each relationship record. When the field is blank or set to Yes, Vault includes the record when creating or updating the content plan.
When using the Copy Content Plan action, only relationships that are used for content planning are copied 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.
The Use for Content Planning field is also respected when dispatching and synchronizing content plans.
To allow users to populate this field, you can add it to the object page layout for any of the following join objects:
- Submission Active Substance (
submission_active_substance__rim) - Submission Country (
submission_country__rim) - Submission Language (
submission_language__rim) - Submission Product (
submission_pharmaceutical_product__rim) - Submission Inactive Ingredient (
submission_inactive_ingredient__rim) - Submission Indication (
submission_indication__rim) - Submission Nonclinical Study (
submission_nonclinical_study__rim) - Submission Clinical Study (
submission_clinical_study__rim) - Submission Pharmaceutical Form (
submission_pharmaceutical_form__rim)
Configuring the Content Plan Hierarchy Viewer
The Content Plan Hierarchy Viewer is automatically available in your Vault, with additional configuration options.
Configuring Drag & Drop
Content Plan 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.
Matched Documents
Users with permission to edit relevant Content Plan Item object types can reorder and drag and drop individual matched documents in the Content Plan Hierarchy Viewer.
Users with permission to upload at least one document type can drag and drop from their desktop to upload and match up to 250 documents to individual Content Plan Items.
These methods require the user to have a permission set with the EDL Matching > Edit Document Matches permission, found under the Application tab.
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 record detail page. You can also add or remove this button on the Submission object record detail page for each Submission object type:
- Navigate to Admin > Configuration > Objects > Submission > 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.
Related Permissions
The following permissions are required for setting up submission content planning:
| 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: Submission | Ability to edit Submission records; users need this to select a content plan template. |
| Security Profile | Admin: Object Lifecycles | Ability to modify object lifecycles; in organizations where the Submissions object uses a lifecycle, Admins need this to set up the lifecycle state entry actions and user actions required for Submission Content Planning. |
| Security Profile | Admin: Object Workflows | Ability to modify object workflows; in organizations where the Submissions object uses a lifecycle, Admins need this access to set up workflows that move a Submissions record to a new state. |
| Security Profile | Admin: Objects: Edit | Ability to edit the object configuration for Content Plan, Content Plan Item, Content Plan Template, and Content Plan Item Template. |
Learn more about permission sets.