With content plan filtering, you can configure content plan templates based on Region, Country, Application Type, Submission Type, Submission Subtype, Supplement Effective Date Type, and Template Constraint Type. This allows you to create more contextual content plans for end users by removing irrelevant sections from your content plan or creating these sections in the Inactive status, eliminating the need to create multiple content plan templates for each combination.
For example, in the US, when submitting an Abbreviated New Drug Application (ANDA), the entire Nonclinical Study Reports section (or Module 4), and parts of other Modules, are not needed. However, when submitting an Investigational New Drug (IND), the Quality section (or Module 3) and parts of other Modules are not necessary. With content plan filtering, you can create content plan templates that only reflect required sections and modules.
Note: This feature is only available for submission and global content plans on RIM Submissions Vaults. See Configuring Submission Content Plans and Configuring Global Content Plans.
About Content Plan Template Constraints
Constraint records allow you to specify when to exclude a content plan section or content plan item and when to create records in the Inactive state. With Constraint records, you can define filters based on a combination of fields, including Region, Country, Application Type, Submission Type, etc., and assign Content Plan Template Constraints.
These constraints indicate which sections and items to exclude and which to create as Inactive during the content plan creation process. To speed up this process, you can use RIM Maintenance to extract and load Content Plan Template Constraints.
Extracting Content Plan Template Constraints
You can use RIM Maintenance to extract Content Plan Template Constraints and specify within the file which records to exclude from a content plan and which to create as Inactive. Extract the Excel️ file first to obtain the most recent content plan template hierarchy for the selected Content Plan Template and constraints.
To extract Content Plan Template Constraints:
- Navigate to a list of Content Plan Template records, either from Admin > Business Admin or a custom tab.
- Choose RIM Maintenance from the Actions menu. You can also access RIM Maintenance directly through the RIM Maintenance tab.
- In the left panel, click Extract.
- From the Actions drop-down, select Extract Content Plan Template Constraints.
- Select a Content Plan Template. Vault only displays templates without a parent record.
- From the Constraint picklist, select the constraint from which to extract the related content plan template constraints. If you don’t see a Constraint, you can create a new Constraint object record from Business Admin. After you choose a constraint, Vault displays the constrained Region, Country, Application Type, Submission Type, Submission Subtype, Supplement Effective Date Type, and Template Constraint Type. The Constraint drop-down only displays constraints of the Application and Submission object type.
- Click Extract.
Vault begins processing the request. When finished, you’ll receive a Vault notification and email with request details and a link to the output file.
Selecting Constraint Options
After you download the extracted Excel file, you can specify which sections and items to exclude, include, or create as Inactive in your template. In the Constraint Option column, enter:
- Include to include the section or item
- Inactive to create the section or item in an Inactive status
- Exclude to exclude the section or item
When you exclude the top-level section, or set it to Inactive, Vault applies this option to all child sections and items. If you need to exclude or inactivate an item, but not its parent section, specify Exclude or Inactive for the item and Include for the section. Vault defaults to Include if you leave the Constraint Option blank or enter an unsupported value. If you specify Inactive and there is more than one Inactive lifecycle state, Vault creates the record in the state first created.
Loading Content Plan Template Constraints
You can use RIM Maintenance to upload previously-extracted Content Plan Template Constraints. This allows you to import your updated constraints into Vault and provides users with more applicable content plans.
To load Content Plan Template Constraints:
- Navigate to a list of Content Plan Template records, either through Admin > Business Admin or a custom tab.
- Choose RIM Maintenance from the Actions menu. You can also access RIM Maintenance directly through the RIM Maintenance tab.
- In the left panel, click Load.
- From the Actions picklist, select Load Content Plan Template Constraints.
- For the File, click Choose to select the content plan template constraints file.
- Click Start Load.
Vault begins processing the request. When finished, you’ll receive a Vault notification and email with request details and the output file.
If you make any modifications to the extracted Excel file other than specifying constraint options, Vault will not create records correctly. This impacts the content plan hierarchy.
Using the Constraints Object
Constraint records, together with Content Plan Template Constraint records, filter content plan sections and items at the time of creation. When creating a Constraint record, you can select filters for the following fields:
| Field | Filters |
|---|---|
| Region | Reference to Application > Region |
| Country | Reference to Application > Lead Market Country |
| CV_1 | Reference to Application Type |
| CV_2 | Reference to Submission Type |
| CV_3 | Reference to Submission Subtype (for submission content plans only) |
| CV_4 | Reference to Supplement Effective Date Type (for submission content plans only) |
| Template Constraint Type | Template Constraint Type picklist |
Optional Constraint Notification Configuration
Upon successful completion of the content plan creation or copy, Vault sends the Create Content Plan Complete (create_edl_complete__v) or Copy from Content Plan Complete (copy_content_plan_complete__v) notification message. You can edit the message to include the ${templateConstraints} token, which can convey to the user the specific template constraint records impacting the related operation.
For example, in a Vault where the Create Content Plan Complete notification message text includes “Some records were created as inactive due to the following template constraints: ${templateConstraints}”, the resulting notification reads, “Some records were created as inactive due to the following template constraints: CST-013948, CST-48249”.