Preparing Submissions for Import (RIM)

Before you can import final submission dossiers in RIM Submissions Archive, you need to set your Vault up for imports. You can also define your submission folder hierarchy.

Note: These features are only available on RIM Submissions Archive Vaults.

How to Set Up for Imports in Vault

When setting up a submission import, you must complete the following:

Create the corresponding Application and Submission object records.
Create Controlled Vocabulary records and set the Controlled Vocabulary Type field to Dossier Import for each type of submission you may import.
Optional: Define the submission folder hierarchy. See details about this step below.

Defining the Submission Folder Hierarchy

You can import submissions without needing to stage submission content outside of Vault to achieve a specific display in the Submissions Archive Viewer tab. Instead, set the following fields to configure the desired folder hierarchy:

On the Submission record, set the Dossier Format field. The Dossier Format field is an object reference field to the Controlled Vocabulary object.
On Controlled Vocabulary records with the Controlled Vocabulary Type field set to Dossier Format, fill in the Parameter field.

The Parameter field stores the target path structure for the dossier format. When you import a Submission, Vault leverages the data in the Parameter field on the related Controlled Vocabulary record to determine how the folder hierarchy should display in the Viewer tab, the naming of the Application and Submission folders, cross-document link navigation, and the submission export structure. See example parameters below.

If you leave these fields blank, Vault imports the submission as usual by leveraging the information contained within the ZIP/TAR.GZ or as staged on FTP.

Example Parameters

You can configure different parameters for different dossier formats. Download the Dossier Format Parameters file to see examples. The Parameter field should only reference fields on the Application and Submission objects.

How Vault Imports Submissions

Vault can import submissions with no application or submission folders defined. If you’re importing from the FTP, Vault still requires you to stage the Application and Submission folders, but you don’t need to configure any additional structuring.

eCTD Submissions

If your submission contains the Index XML at the root within the first or second folder, Vault imports the Submission as an eCTD. If you’ve defined a Dossier Format and Parameter, Vault uses the first two (2) parameter values to define the Application and Submission folders. If you define more than two (2) folder parameters, the import fails.

eCTD submissions display as usual in the Viewer tab. When defined, Vault also leverages the Dossier Format and Parameter fields for submission export and cross-document link navigation.

For example, you’ve set your submission’s Dossier Format to eCTD, and the Parameter for eCTDs is {application__v.folder_name__v}/{submission__v.xml_submission_id__v}. The Folder Name is set to NDA 123456 and the XML Submission ID is 0000. Your submission contains the Index XML within a single Submission folder called “0000”, as well as a “0000-working-documents” folder at the root.

When you import your submission, the contents of the “0000” folder, including the Index XML and other files, exist within the submission folder path nda123456/0000. Vault imports the “0000-working-documents” folder as a non-eCTD/Unreferenced File, with the folder path nda123456/0000-working-documents. This folder displays at the same level as the util folder in the Viewer tab.

Non-eCTD Submissions

If your Submission contains a file other than the Index XML at the submission root or within the first or second folder, Vault imports the Submission as a non-eCTD.

If you’ve defined a Dossier Format and Parameter, Vault uses the first two (2) folder parameter values to define the Application and Submission folders and any additional parameters to define the section display within the Viewer tab. When defined, Vault also leverages the Dossier Format and Parameter fields for submission export and cross-document link navigation for non-eCTD submissions.

For example, you’ve set your submission’s Dossier Format to Paper (CTD), and the associated Parameter is {application__v.folder_name__v}/{submission__v.xml_submission_id__v} /Paper/{submission__v.name__v}. The Folder Name is set to NDA678910 and the XML Submission ID is 2019-01-23 Labeling Update. Your submission contains a toc.pdf file at the submission root, with no folder structure defined.

The submission’s folder path in the Viewer tab is Paper/2019-01-23 Labeling Update. When you export the submission or navigate links, the folder structure is nda678910/2019-01-23 Labeling Update.

eSTAR Submissions

If your submission contains at least one PDF that is XFA format, Vault can import it in the eSTAR format. To do this, set your submission’s Dossier Format to eSTAR prior to import and ensure your Vault has a Controlled Vocabulary record for the eSTAR dossier format with the Vault RIM UUID value set to f4941703-6ac5-471d-8649-c4f53673353d.

eSTAR submissions must be 4GB in size or smaller. Submissions with eSTAR Dossier Format that are over the 4GB limit will be imported as a non-eCTD. No file extraction, but the original XFA will be imported.

Importing Submissions via File Staging

When using your Vault’s file staging server, the root folder should be named “SubmissionsArchive”, followed by the Application sub-folder, and then individual Submission sub-folders. Depending on the Application Folder Name and the submission’s XML Submission ID, or the Parameters and Dossier Format (if defined), Vault can select the right folder by default.

Users with the File Staging permission may also upload and import submissions via a Submissions Archive Import folder within their personal file staging directory in addition to the root SubmissionsArchive folder.

If these folders don’t exist within your Vault’s file staging server, you’ll need to create them.

See the API reference documentation on importing submissions for more information.

The following permissions control your ability to define the submission folder hierarchy for import:

Security Profile

Object: Controlled Vocabulary: Create, Edit: Controls ability to create Controlled Vocabulary records; ability to define a Parameter on existing records to determine the imported submission’s folder structure.
Object: Submission: Edit: Controls ability to select a Dossier Format for a Submission.