RIM Submissions Archive allows you to upload submission documents directly from Vault File Manager. Uploading through Vault File Manager simplifies how you import dossiers and eliminates the need to stage files on the Vault File Staging Server or prepare ZIP files for import.
Once you submit a dossier to the Health Authority’s electronic gateway, you can initiate an import from the Submission record in Vault and then drag and drop your dossier from your computer to Vault File Manager to upload and import submission files. While your submission files are uploading, you can monitor the upload progress in Vault File Manager and work on other activities in Vault without interrupting the upload.
Note: This feature is only available on RIM Submissions Archive Vaults, and your Admin must configure it before you can use it. Vault File Manager supports Windows version 7 and later. We recommend that Windows 7 users install Visual C++ Redistributable for Visual Studio 2015 to use Vault File Manager.
About Shared Network Drives
If your organization uses a shared network drive for storing submission files, we strongly recommend instead using your Vault’s File Staging Server to import with Vault File Manager (VFM).
Importing submissions or any other documents from a shared network drive via Vault File Manager is not recommended. This is primarily because shared drives may allow file path lengths to exceed the 256-character limit enforced by Windows. When the limit is exceeded, Vault File Manager returns an error: “Location specified does not reference a valid import”.
How Vault Imports from Vault File Manager
To upload from Vault File Manager, you first start the import from a Submission record in your Vault. When Vault File Manager opens, you upload the submission folder or ZIP/TAR.GZ file there. Initiating the upload in Vault File Manager creates an upload package, and the Vault API integrates with Vault File Manager to transfer your submission content to a temporary SubmissionsArchive > VFMTemp folder on the File Staging Server. Once the submission content upload is complete, Vault queues the content for import to the Submission record and follows the same import process as if you uploaded content directly in Vault or using the Staging Server.
Installing Vault File Manager
Before you import a submission, ensure that Vault File Manager is installed on your computer. See Vault File Manager for Windows for detailed instructions.
Importing from Vault File Manager
You can use Vault File Manager to upload new submission content for the first time or to replace a submission dossier that was imported previously. To import submission content from Vault File Manager:
- Navigate to the Submission record from Business Admin or a custom tab. You may also be able to access submissions from their related Application records.
- From the Actions menu, select Import. If there is already a dossier associated with the submission, you can select Reimport to remove the previous dossier and import a new one.
- In the Import Submission dialog, choose Vault File Manager.
- Click Next. Vault prompts you to open Vault File Manager.
- If you are not already logged in to Vault File Manager, you’ll need to do so first. Once you are logged in, Vault File Manager opens a New Upload tab.
- Drag and drop your submission folder or ZIP/TAR.GZ file into the gray box, or click Choose to select a file. You can only upload one submission folder or ZIP/TAR.GZ file at a time. If you are importing an eCTD submission with unreferenced files, you can select the submission folder and additional folders containing the unreferenced files.
- Optional: If you want to select a different file, click X in the Files to be Uploaded section and then choose a new document. If you don’t want to upload a file, click the Cancel button or click X to close the New Upload tab.
- Click Start Upload. Vault closes the New Upload tab and opens the Uploading tab. From this tab, you can track upload progress. If you have ten (10) concurrent submission uploads in progress, you can’t proceed with another upload.
- When the upload is complete in Vault File Manager, Vault queues the dossier for import. Vault updates the Submissions Archive Status field on the Submission record throughout the upload and import process, so you can track the current status.
You’ll receive email notifications when the import is complete or when the import encounters an error. The notification includes any import warnings that you would usually see in the confirmation dialog in Vault.
Uploading eCTDs with Unreferenced Files
If you are uploading an eCTD submission dossier with unreferenced files, you can select multiple root folders in the New Upload tab. For example, to import eCTD submission 0003 with unreferenced files, you would select both the 0003 folder and the 0003-workingdocuments folder. Once you start the upload, the Filepath in the Uploading tab displays one of the root folders with a note about the additional folder. Hover over the row to see both root folders.
During upload, Vault detects the folder containing the Index XML and recognizes it as the folder containing the submission dossier. After the import is complete, you can see the contents of the 0003 folder displayed in eCTD format in the Submissions Archive Viewer. The 0003-workingdocuments folder containing the unreferenced files appears at the same level as the util folder.
Note: Vault File Manager only supports uploading multiple folders when importing unreferenced files with an eCTD submission dossier. If Vault cannot detect the Index XML when you select multiple folders for upload, the import will fail.
About Submission Files
If you are uploading a directory, you must choose the submission folder and not the application folder in order for the import to complete successfully. For example, if your target submission content is in the NDA 123456 > 0000 Initial Application directory, select the 0000 Initial Application submission folder. If you are uploading a ZIP/TAR.GZ file, you can compress the application folder to import it.
Tracking Upload Progress
In the Uploading tab, Vault includes a row for each submission upload that is currently in progress. The columns include details about the submission, and you can sort on each column:
- Filepath: The local path of the root folder or the file location of the ZIP/TAR.GZ file you uploaded.
- Upload Type: The upload type will always be Submission Archive Import.
- Destination: The Application and Submission record names in Vault, for example, NDA12345 > 0000. This allows you to identify the Submission record to which you are uploading.
- Size: The size of the folder directory or ZIP/TAR.GZ file you uploaded.
- Upload Status: A progress bar indicates the current upload status. You can also see if an error occurred and hover over the icon to see details.
- Date Added: The date you uploaded the submission file.
About Paused Uploads
Vault File Manager must be open on your computer or running in the background in order to transfer submission files to Vault. If you exit or log out of Vault File Manager, if it crashes, or if your internet connection fails, the upload will pause. The upload will continue where it left off the next time you open or log in to Vault File Manager, or when your internet connection resumes. If the upload has not completed after seven (7) days, it will expire and you will receive an upload error notification.
Skipping Uploads
When concurrent uploads are pending, you can move an upload to the back of the queue manually in Vault File Manager. In the Uploading tab, right-click anywhere on a row with the Pending Upload status and select Skip Upload. Skipped uploads move to the end of the queue and are initiated after all other uploads have completed.
Canceling Uploads
You can cancel a submission file upload directly from Vault File Manager or within Vault.
- To cancel a submission file upload from Vault File Manager, right-click anywhere on that row in the Uploading tab and select Cancel.
- To cancel a submission file upload from Vault, navigate to the Submission record and select Cancel Upload from the Actions menu.
When you cancel the upload, Vault updates the Submissions Archive Status field field to NULL. If you cancel an upload while reimporting a submission dossier, Vault updates this field to ERROR.
Removing Uploads
You can remove a row from the tab after an upload is complete or when an upload encounters errors. Right-click anywhere on the row you want to remove and click Remove Upload.
Failed Uploads
Uploads fail for different reasons, such as internet connection issues or corrupted files. You have different options when uploads fail, depending on the Upload Status in Vault File Manager:
- Upload Failed: You can retry these uploads directly in Vault File Manager rather than restarting the import from your Vault. Right-click on the row and select Retry.
- Upload Corrupted: You cannot retry these uploads. Right-click on the row and select Cancel and Remove.
Limits
API Transaction Limits
Vault limits the number of API calls that can be made every 5 minutes (burst). Because the Vault API supports submission import from Vault File Manager, Vault enforces the API transaction limits when you upload submission content. You should be mindful of existing custom integrations in your Vault and other concurrent uploads in Vault File Manager to ensure that your Vault doesn’t exceed the API burst limits.
File Limits
Submissions can be a single ZIP or GZ file, or a folder of 100,000 or fewer files uncompressed.
- When a single ZIP or GZ file is used, the file must be under 10GB in uncompressed size.
- When a folder of uncompressed files is used, the Submission must be under 100GB in size.
Note: File names cannot include non-UTF-8 characters. See Importing Submissions for more information.
Related Permissions
You need the permissions detailed in Importing Submissions in order to import from Vault File Manager.