# Configuring Submission Content Plans (RIM) 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.
## Content Plans & EDLs {#content-plan-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 {#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: 1. Set up [custom tabs][6] for the _Content Plans_ object and the _Content Plan Templates_ object to give access to users outside of the **Admin** area. 2. Set up actions on the [_Submission_ object lifecycle][7] to allow users to create or update the related content plan. 3. Optional: Configure additional [system actions, entry actions, entry criteria, and user actions][8] on the _Submission_, _Content Plan_, or _Content Plan Item_ object lifecycles to fit your organization's business processes. 4. Create [content plan templates][9] using the _Content Plan Template_ and _Content Plan Item Template_ objects, tokens, and constraints. 5. 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][30] for details. 6. Optional: Configure the [_Exclude from Auto-matching_][31] field to prevent auto-matching on individual _Content Plan_ and _Content Plan Template_ records. 7. Optional: Configure the [_Include Previously Matched Documents_][11] field to allow a content plan to include documents that previously were matched to another submission within the same application. 8. Optional: Add the [_Use for Content Planning_][12] 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. 9. 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. 10. Optional: [Configure][29] the Content Plan Hierarchy Viewer to allow users to drag and drop to copy and reuse content plan sections. 11. Optional: Add the [**Content Plan** button][15] to the _Submission_ 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 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 for more information. 14. 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_ 15. Optional: [Configure][33] various object page layouts to support creating Submission Content Plans for markets that distinguish between the Open/Applicant's Part and the Restricted Part for the Active Substance section in the CTD structure.
## Setting Up Custom Tabs {#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 {#lifecycle} You can define additional lifecycle state user actions, entry actions, entry criteria, or workflow system actions to allow users to perform various actions, such as creating or copying a content plan. See Managing Content Plans with a Lifecycle for more information. 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. ## Creating Content Plan Templates {#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 {#about-matching-job}
To disable auto-matching in your Vault: 1. Remove any lifecycle state entry actions controlling the behavior of the _Match Documents_ (`batch_update__v`) field within the _Content Plan_ object. 2. For the _Match Documents_ field within the _Content Plan_ object: * Configure the field's default value such that any new records will be set to "No" (false). * Ensure the field is set to "No" (false) or is blank within all _Content Plan_ records. 3. Select the _Exclude from Auto-Matching_ checkbox field within all _Content Plan Template_ records. This is a secondary measure in the event Step 1 is only partially executed. 4. Optional: Remove the below fields from their respective object page layouts: * _Content Plan_ object: _Exclude from Auto-Matching_ and _Match Documents_ * _Content Plan Item_ object: _Match Documents_ * _Content Pan Template_ object: _Exclude from Auto-Matching_ 5. Optional: Review your Vault's user permissions for the fields in Step 4 and ensure users are no longer able to update them. This is a secondary measure to prevent users from, for example, updating the _Match Documents_ field via in-line editing to "Yes". ### About the Include Previously Matched Documents Field {#include_previously_matched} 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.
### About the Exclude from Auto-Matching Field {#about-exclude-from-auto-matching} 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: 1. 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. 2. 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 {#use_for_content_planning} 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 {#enable-viewer} The Content Plan Hierarchy Viewer is automatically available in your Vault, with additional configuration options. ### Configuring Drag & Drop {#content-plan-copy} #### 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: 1. If not already configured, add and activate the **Create Sibling** record action on both the _Content Plan_ and _Content Plan Item_ objects, and the **Add Document** and **Create Child** record actions on the _Content Plan Item_ object. 2. Review and update your Vault's Action Level Security configuration for the **Create Sibling**, **Create Child**, and **Add Document** 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. 3. Ensure users are assigned permission set with the following: * **EDL Matching > Edit Document Matches** permission, found under the **Application** tab * _Execute_ access for the _Add Document Content Plan Item_ object action (**Objects > Content Plan Item > Object Action Permissions**) #### 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 following: * **EDL Matching > Edit Document Matches** permission, found under the **Application** tab. * _Execute_ access for the _Add Document Content Plan Item_ object action (**Objects > Content Plan Item > Object Action Permissions**) ### Enabling the Content Plan Button {#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** (content plan open tree view) 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: 1. Navigate to **Admin > Configuration > Objects > Submission > 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**. ### Configuring Content Plan Creation for ASMF & APIMF {#asmf-apimf} Vault supports creating Submission Content Plans for markets that distinguish between the Open/Applicant's Part and the Restricted Part for the Active Substance section in the CTD structure. This is applicable, for example, for EU Active Substance Master Files (ASMFs) and WHO Active Pharmaceutical Ingredient Master Files (APIMFs). To do this: 1. Add the _Information Classification_ picklist field to the object page layouts of the following objects: * _Application Active Substance_ object * _Regulatory Objective Active Substance_ * _Submission Active Substance_ * The _Summary (Module 2)_ and _Quality (Module 3)_ object types of the following objects: * _Content Plan_ * _Content Plan Item_ * _Content Plan Item Template_ * _Content Plan Template_ 2. Within the _Active Substances_ panel of the below object page layouts, add the _Information Classification_ field to the list of default columns. * _Application_ * _Regulatory Objective_ * _Submission Active Substance_ 3. Update your Vault's CTD Content Plan Template to include the following sections, tagged with the correct _Information Classification_ picklist values: * ASMF Applicants & Restricted Part * APIMF Open & Restricted Part
## 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. [6]: #custom-tabs [7]: #submission-lifecycle [8]: #lifecycle [9]: #templates [11]: #include_previously_matched [12]: #use_for_content_planning [14]: #enable-viewer [15]: #content-plan-button [29]: #content-plan-copy [30]: #about-matching-job [31]: #about-exclude-from-auto-matching [33]: #asmf-apimf