RIM Basics: Submissions Archive is an optional add-on to RIM Basics: Submissions that allows you to view and import published submissions sent to Health Authorities.
Only users with the optional Submissions Archive Full User license can use the Submissions Archive.
Preparing Submissions for Import
To prepare a submission for import, locate the submission’s ZIP file from your third-party publishing tool that contains the submission content you submitted to the Health Authority.
We recommend creating one (1) folder in your storage location for each application and storing each submission’s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission to RIM Basics: Submissions Archive.
Ensure that the submission ZIP file contains content for one (1) submission only. For eCTD submissions, Vault expects the submission folder to contain the index.xml file created by your third-party publishing tool.
Before importing a submission ZIP file, ensure that you have populated the following fields:
- In the Details section of the associated application, ensure that you have entered the Application Folder Name using the format expected by the Health Authority, if applicable.
- In the Details section of the associated submission, ensure that you have selected the Dossier Format.
- In the Planning and Tracking Details section of the associated submission, ensure that you have entered the Sequence ID.
Importing Submissions to the Archive
If your submission is smaller than 4 GB, you can import it to the Submissions Archive directly from the file’s local storage location. If your submission is larger than 4 GB, you must first upload it to Vault’s file staging server using an FTP client.
Importing Submissions
Complete the following steps to import a submission smaller than 4 GB to the Submissions Archive:
- Navigate to the Submission Mgmt > Submissions tab and open the submission you want to import.
- From the All Actions menu, select Import.
- In the Submissions Archive Import dialog, choose your submission ZIP file using one of the following methods:
- Click Choose and select the ZIP file that contains the submission you submitted to the Health Authority.
- If you have previously used an FTP client to import a submission to this Vault, the Upload now and FTP user folder options are displayed. Select Upload now, click Choose, and select the ZIP file that contains the submission you submitted to the Health Authority.
- Click Next. Review the information in the dialog to ensure that the folder names and number of files are correct and as expected.
- Click Import. A message is displayed to indicate that the import is in progress, and Vault changes the submission’s Dossier Status to Import In Progress.
- After you receive a notification in the Notifications panel that the import process is complete, click Refresh to refresh your browser.
- To view details about the import results, click the Submissions Archive Import Results file in the Attachments section of the submission to open the results file.
Importing Large Submissions from the File Staging Server
When you need to import a submission larger than 4 GB to the Submissions Archive, you must first upload it to your FTP user folder on Vault’s file staging server using an FTP client. Vault provides an FTP user folder to each Vault user. Each user has access to their own user folder and cannot access another user’s folder. However, if you configure delegate access to your account, the delegate can access your user folder and its contents.
Important: If this is your first time uploading a submission to the file staging server using an FTP client, you must create a folder inside your FTP user folder named Submissions Archive Import. Ensure that you enter the folder name exactly because Vault looks for this folder when populating the list of submissions you can import from the file staging server.
When you upload a submission to your user folder using an FTP client, ensure that you upload the unzipped submission folder and its contents instead of the ZIP file itself. You can upload more than one (1) submission folder to your FTP user folder, but you can only import one (1) submission folder to the Submissions Archive at a time.
Complete the following steps to import a submission larger than 4 GB to the Submissions Archive using an FTP client:
- Access your FTP client and upload the submission folder to your FTP user folder on Vault’s file staging server.
- Navigate to the Submission Mgmt > Submissions tab and open the submission you want to import.
- From the All Actions menu, select Import.
- In the Submissions Archive Import dialog, select FTP user folder and select the submission folder from the drop-down.
- Click Next. Review the information in the dialog to ensure that the folder names and number of files are correct and as expected.
- Click Import. A message is displayed to indicate that the submissions archive import is in progress, and Vault changes the submission’s Dossier Status to Import In Progress.
- After you receive a notification in the Notifications panel that the import process is complete, click Refresh to refresh your browser.
- To view details about the import results, click the Submissions Archive Import Results file in the Attachments section of the submission to open the results file.
Exporting Submissions
You are also able to export a dossier for each submission and select specific components within the eCTD structure, if needed. Because the export maintains the same folder structure used during import, you can use this option to leverage exported submissions or components for other regions. Exporting can also simplify the process of distributing dossiers with local affiliates or publishing partners.
To export a submission dossier:
- Navigate to the Submission Mgmt > Submissions tab and open the submission you want to export.
- Choose Export from the All Actions menu.
- From the Refine Selection page, review the structure of components. Select Export entire submission archive to include all components, or use the checkboxes to select specific components or subsections.
- Click Next.
- From the Confirmation page, review the summary. Click Finish to begin exporting.
- You will receive a notification when the process is complete. Click the included link to download a ZIP file.
| Note: The export file name will not include the following characters: <,>,:,”“,/,** | ,?,*** |
Exporting Large Submissions
If submissions exceed export limits and you have the correct permissions, you can choose to export the submissions to the Vault File Staging Server rather than reducing your export size.
You can find all exported content in the Submissions Archive Export folder, within your personal user folder on the Staging Server. The folder structure and folders match those used during submission import. From here, you can download the export at your convenience. Your export also includes a Manifest log file, an Export Summary file, correspondence documents (if enabled), and a failure log file.
Limits
Vault places some limits on exports:
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Exports cannot include more than 50,000 files.
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The total export cannot exceed 5.3GB (5368709120 bytes).
Archiving Submissions
Complete the following steps to archive a submission after importing it to the Submissions Archive:
- In the Submission Mgmt > Submissions tab, open the submission you imported to the Submissions Archive and click Edit.
- Enter the Actual Submission Date for when the submission was sent to the Health Authority.
- Click Save to save the changes.
- From the Workflow Actions menu, select Change State to Archived.
- In the confirmation dialog, click Yes to confirm that you want to change the submission’s status to Archived.
Viewing Archived Submissions
Complete the following steps to view an archived submission:
- Navigate to the archived submission using one of the following options:
- Navigate to the Submission Mgmt > Viewer tab and select the Application from the Applications drop-down for the archived submission you want to view.
- Open the submission in the Submission Mgmt > Submissions tab and select View from the All Actions menu. Vault opens the archived submission in the Submission Mgmt > Viewer tab.
- From the archived submission’s Actions menu, select Expand All to view the archived submission’s imported content.
- Click a document name in the archived submission hierarchy to view the imported document.