# 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.
## About Node Extensions & Study Tagging Files The US eCTD specification supports only Study Tagging Files (STFs). Node extensions are not accepted by the FDA.
## 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.
### Submitting a New Grouped Submission To create a new grouped submission: 1. Navigate to an existing _Submission_ record. 2. 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_. 3. From the **Related Submissions and Application** section, click **Create**. 4. 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. 5. Enter a **Description**. 6. Select a **Related Application**. This field only displays applications that share the same application type. 7. Select a **Related Submission ID**. This field depends on the _Related Application_ and _Lead Submission_. 8. Optional: You can repeat steps 3 through 7 to add multiple applications to a grouped submission 9. From the _Submission_ record **Actions** menu, choose **Create Content Plan**. 10. 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.
1. To start your import and select your submission file and import method, follow the instructions in [Importing Submissions](/en/lr/28082/). You must select either **Import Now** or one of the **FTP** options in the **Import Submission** dialog. You cannot use Vault File Manager or Vault API to import grouped submissions. 2. In the import confirmation dialog, review the application folder name, submission folder name, and any warnings. If these details are acceptable, click **Import**. 3. On the _Submission Import_ page, map each application and submission in the grouped submission to existing _Application_ and _Submission_ records in your Vault. 4. 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. ## About Ad Promo Submissions 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. ### Submitting an Ad Promo Submission To submit an Ad Promo submission: 1. Navigate to the _Submission_ record in **Admin** > **Business Admin** or a custom tab. 2. Select the applicable audience type from the **AdPromo** picklist. 3. 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. [1]: https://www.fda.gov/ectd [2]: /wordpress/28082