Working with US Regulatory Submissions (RIM)

When working with US regulatory submissions, Submissions Publishing allows you to publish and submit grouped submissions and Ad Promo submissions to the FDA.

Grouped submissions are useful for collecting and including multiple files into one application, which is considered the primary or lead application. When publishing a grouped submission, you’re publishing the primary application.

Ad Promo submissions allow you to easily specify advertisement and promotional materials within section 1.15 of a submission.

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

About Applicant Contacts

The US Regional XML requires you to list at least one contact for a grouped submission. Vault validates this by pulling from the Submission Contact join record. When a contact is required to be listed for multiple contact types, for example, Regulatory and Technical Contacts, Vault consolidates contacts based on the matching Contact Type and email address.

Grouped Submissions

A grouped submission is a single sequence containing one set of files that are applicable for more than one application. This type of submission improves the process and eliminates the need to submit multiple, identical submissions for different applications. For example, a product change may occur impacting multiple applications. With grouped submissions, you can create a new sequence to note the product change, and that sequence would then point to all impacted applications.

To support group submissions, the Submissions Publishing application includes the Grouped Submissions object type on the Related Submissions and Applications (previously labeled Related Submissions) object. When you select a Related Application from a Grouped Submission type, Vault uses dynamic reference constraints automatically configured as part of the Submissions Publishing application to display only available Applications that match the current parent’s application type.

Note: The FDA provides specific rules for submitting grouped submissions. See the FDA specifications for further details on grouped submissions.

Submitting a New Grouped Submission

To create a new grouped submission:

Navigate to an existing Submission record.
In the Publishing Details section, confirm that the Submissions Contains Files field is set to Yes. This field determines which submission will be the lead in the XML for a grouped submission. If this field is set to No, the submission is a child of a grouped submission and prevents content plan creation and deletion. Note that when you create a related submission of the Grouped Submission type, Vault automatically sets this field to No.
From the Related Submissions and Application section, click Create.
Select Grouped Submission from the Select Related Submission Type picklist. This allows you to group submissions across multiple applications, as well as define related applications.
Enter a Description.
Select a Related Application. This field only displays applications that share the same application type.
Select a Related Submission ID. This field depends on the Related Application and Lead Submission.
Optional: You can repeat steps 3 through 7 to add multiple applications to a grouped submission
From the Submission record Actions menu, choose Create Content Plan.
Click Save.

Details for Grouped Submissions

You’ll need to consider the following when working with grouped submissions:

You can only include one application type (for example: NDA) and one submission type (for example: Labeling Supplement) in a grouped submission.
Grouped submissions only support DTD version 3.3 or higher.
A rejection for any reason will lead to rejection for all applications in the group.
You can “ungroup” submissions at any time by submitting files to a single application.

About Leaf Operations

All leaves within an initial grouped submission must be set to New. For subsequent submissions within the group, you can either set the leaves to New or a set them to a specific operation (Replace, Append, or Delete) against a file created as part of the group. Vault cannot apply an operation on a file submitted outside the group. When using the Select Leaf Operation action, Vault will only display valid targets to apply the operation on.

Details for Grouped Submission IDs

The FDA requires a submission ID for each submission. For grouped submissions, you need to capture the submission ID for each of the applications in that group. Anywhere there is a submission ID or a related application, you’ll have to add them as a related submission on the applicable individual submission.

Publishing Grouped Submissions

When publishing a grouped submission from the lead Submission record, Vault creates the binder in Submissions Archive for review. When you’re ready to submit, you can set the Enable Continuous Publishing field to No to copy the Submissions Archive binder to each of the applications. Vault also creates a published output in all submissions within the group. Additionally, when you run the On Demand Publishing and Validation action with the Enable Continuous Publishing field set to No, Vault also recreates the Submissions Archive binder for each of the applications.

Importing Grouped Submissions

After you finalize your grouped submission dossier, you can import it in Submissions Archive.

Note: To ensure Vault can successfully auto-match Submission and Application data for mapping during import, initiate grouped submission imports from a primary lead submission, rather than a non-primary submission.

To start your import and select your submission file and import method, follow the instructions in Importing Submissions. You must select either Import Now or one of the FTP options in the Import Submission dialog. You cannot use Vault File Manager or the API to import grouped submissions.
In the import confirmation dialog, review the application folder name, submission folder name, and any warnings. If these details are acceptable, click Import.
On the Submission Import page, map each application and submission in the grouped submission to existing Application and Submission records in your Vault.
Click Import.

When the import is complete, Vault duplicates the content in the grouped submission to each Submission record you selected on the Submission Import page.

When completing a US FDA eCTD submissions, sponsors typically submit advertisement and promotional materials (Ad Promo) as part of Module 1. With the Submissions Publishing application, you can associate documents to the applicable promotional material nodes from within a content plan.

The Submissions object now includes the AdPromo Scope field to support AdPromo Submissions. When users create a content plant from a content plan template, Vault creates the m1.15 section based on the AdPromo Scope field selection and sets the correct values for the generated XML. This automated process decreases the possibility of errors and helps reviewers better identify promotional materials.

To submit an Ad Promo submission:

Navigate to the Submission record in Admin > Business Admin or a custom tab.
Select the applicable audience type from the AdPromo picklist.
From the Actions menu, choose Create Content Plan.

Based on the selected value and the defined values of XML Attribute/XML Attribute Type fields in a content plan template, the content plan structure will include AdPromo sections necessary for the submission.

Publishing an AdPromo Submission

When publishing an Ad Promo submission, Vault ensures the following:

A warning is issued if the submission includes multiple 1.15 or 1.15.2 sections
The required Material ID and Issue Date are pulled from the matched document properties
Documents are included in the correct sections based on the matched Material ID and Issue Date

Once you publish the content, you can view it in Submissions Archive.