RIM Submissions Archive allows you to import final submission dossiers for your organization’s records and users’ later review.

Setting Up for Imports in Vault

Before you import submissions, you must set up your Vault to do this. You can also define your desired folder hierarchy for various submission types within your Vault so you don’t need to stage submission content outside of Vault. See Preparing Submissions for Import for detailed instructions and information about how Vault imports submissions.

Supported DTD & Schema Versions for Import

Vault supports the following eCTD DTDs and schemas at this time. Imports will fail for submissions that use an unsupported version.

  • ICH 3.2, 3.0
  • ICH-STF 2.2
  • Australia (AU) 0.90, 3.0, 3.1
  • Canada (CA) 0.9, 1.0, 2.2
  • China (CN) 1.0
  • Eurasian Economic Union (EAEU) R.022 1.0
  • European Union (EU) 0.9, 0.92, 1.0, 1.1, 1.2.1, 1.3, 1.4, 2.0, 3.0, 3.0.1
  • Gulf Cooperation Council (GCC) 1.0, 1.1
  • Japan (JP) 1.0
  • Jordan (JO) 1.0, 1.1
  • Korea (KR) 1.0
  • South Africa (ZA) 1.0, 2.1
  • Switzerland (CH) 1.0.1, 1.1, 1.2, 1.3, 1.4, 1.5
  • Taiwan (TW) FDA v1.1 (DTD 1.0)
  • Thailand (TH) 0.92, 1.0
  • Ukraine (UA) 1.0
  • United States (US) 2.01, 3.3

Importing Submissions

You can import submission dossiers in several ways.

How to Import Submissions

To import a submission dossier:

  1. 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.
  2. From the Actions menu, select Import.
  3. In the Import Submission dialog, choose Upload now to upload submissions under 4GB that contain less than 20,000 documents as a ZIP/TAR.GZ file. To add larger dossiers via FTP, choose whether to upload to the FTP root folder or FTP user folder and use the drop-downs to select a folder from either the root SubmissionsArchive folder or from the Submissions Archive Import folder in your personal FTP directory. If you’re working on a Windows computer, you can also choose Vault File Manager to import the submission dossier from the Vault File Manager client. See also File Size Limitations.
  4. Click Next.
  5. In the confirmation dialog, review the application folder name, submission folder name, and any warnings. If these details are acceptable, click Import. If your submission contains an invalid XML, Vault displays a warning or blocks the import, depending on your Admin’s configuration. In order to import your submission, it must contain the util folder and the XMLs cannot be malformed.
  6. Optional: When enabled, you can also choose to manually map submission data to various Vault object records if you are importing an eCTD submission and the XML contains elements with attribute information. This option is not available when you import using Vault File Manager or the API.
  7. Vault populates select document fields automatically on import, creates or updates a related Dossier Details record, and updates the Submission Archive Status field on the Submission record throughout the import process. When the import is complete, you’ll receive an email and a Vault notification. Vault also adds the import results as an attachment on the Submission record if attachments are enabled on the Submission object

In the Import Submission dialog, Vault hides the option to upload to the FTP root folder if there is no SubmissionsArchive folder in the FTP root. Vault hides the FTP user folders option if you don’t have File Staging permission, or if there is no Submissions Archive Import folder within your FTP folder.

In the FTP tool, the SubmissionsArchive folder is visible to System Administrator and Vault Owner security profiles. All other users with FTP staging access should stage imports to the FTP user folder.

How to Import Common Submissions in Bulk

From a list of Submission records, you can import a single dossier to multiple submissions using a bulk action. When importing in bulk, we recommend using this method for any submission which is not a US eCTD grouped submission.

On the Choose Action page, select the Submissions Archive > Import action. On the Submission page, the import options you see depend on your permissions and FTP configuration. When enabled, Vault also includes a step to manually map submission metadata to various Vault object records for eCTD submissions.

When you click Finish, Vault imports the dossier asynchronously and sends you an email and a Vault notification containing import successes and failures.

Importing US eCTD Grouped Submissions

To import US eCTD grouped submission dossier files, create any additional Submissions in the Vault UI first, then import the files. During this operation, Vault prompts you to map the additional Submissions referenced in the regional XML.

We recommend this method as other import methods (API, Vault File Manager) do not provide a mapping page and therefore do not automatically import into the secondary Submissions.

How to Reimport Submissions

You may need to replace a submission that was imported previously, for example, when a leaf operation is incorrect or a file needs to be replaced prior to finalizing the dossier. With the Reimport action, you can remove the previous submission and import a new submission in a single step:

  1. 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.
  2. From the Actions menu, select Reimport. Your Admin must grant you the correct permissions to see this action.
  3. Select an import option from the Import Submission dialog and complete the import.
  4. Vault removes the existing dossier and queues the new dossier for import. Once the import is complete, Vault will send you a notification and up-version the import results attachment file on the Submission record, if results vary from prior imports.

About Submissions Archive Documents

When you import a submission, Vault automatically creates a Source References relationship between the source document and the Submissions Archive-type document when the file’s checksum matches. If an active Content Plan Item record in the submission content plan has a Published Output Location that corresponds to a file location in the current import, Vault uses the matched document as the source for the Submissions Archive-type document as well.

At submission import, Vault also populates the following document fields:

  • Applications (applications__v): Any Applications to which the archived document belongs.
  • Submissions (submissions__v): Any Submissions to which the archived document belongs. This field updates each time the document is used.
  • Archive Sections (archive_sections__v): The top-level XML element (for eCTD submissions) or top-level folder (for non-eCTD submissions) where the archived document exists.
  • Submissions Archive Document Section (submissions_archive_document_section__v): Locations of a document inside an archived submission. For eCTD submissions, this is the XML element path (excluding node extensions), for example, m2-common-technical-document-summaries/m2-2-introduction. For non-eCTD submissions, this is the document’s complete folder path, for example, 5 LABELING/5.01 Chapter Table of Contents.

You can search on these fields to find submission documents in your Vault.

About Dossier Details

When the submission import completes successfully, Vault creates a new Dossier Detail record or updates the following fields if a record already exists:

  • Dossier Status: The status of the associated dossier. Similar to Submissions Archive Status, Vault updates this field as the submission progresses through import or removal.
  • File Count: The number of files in the associated dossier.
  • Size MB: The size of the associated dossier.

You can access the related Dossier Detail record from the Dossier Detail field on the Submission record.

Accessing Submission Import Results

When the submission import completes, you’ll receive an email and a Vault notification. If attachments are enabled on the Submission object, Vault also adds the import results as an attachment on the Submission record.

To view the import results CSV file, open the Submission record and expand the Attachments section. From here, you can work with attachments as usual. If you reimport the submission dossier, Vault up-versions the existing attachment.

About Duplicate Content Detection

If your Admin has enabled Duplicate Content Detection, Vault reuses existing Submissions Archive documents based on the MD5 checksum value rather than creating duplicate documents each time you import a new submission. See Using Duplicate Content Detection for additional information about how Vault prevents duplicate documents.

About XML Renditions

When you import a submission containing valid XML files, Vault creates PDF viewable renditions based on the DTD/XSD and stylesheet included in the submission. To generate renditions for existing submission XMLs, select Re-render Document from the XML file’s Actions menu.

Vault can generate PDF renditions for the following XMLs:

  • Index
  • Regional (us-regional, eu-regional, etc.)
  • SPL
  • STF
  • Define

EAEU R.022 XML files are not rendered.

Removing Submissions

You may occasionally upload incomplete submissions or submissions with mistakes. When you remove a submission, Vault deletes any sections created in the archive binder because of the submission import and removes any documents in the submission from the archive binder. This does not delete the documents from Vault, but the documents no longer appear in the Viewer tab, and users will not be able to access them using cross-document navigation. Vault also clears the Applications and Submissions document field values.

How to Remove Submissions

To remove a submission, navigate to the individual Submission record and select Remove from the Actions menu. You do not need to wait for Vault to finish removing a submission before removing a second.

Canceling Imports & Removals

If you need to remove a submission that has not yet finished importing, you can choose Cancel Import from the submission record’s Actions menu. Conversely, you can cancel an in-progress removal by selecting Cancel Removal.

About the Submissions Archive Status Field

Vault updates the Submissions Archive Status field (archive_status__v) as submissions progress through import or removal.

Status Description
Empty There is no imported content associated with the Submission record.
TRANSFER_INITIATED Submission content is uploading in Vault File Manager. After the upload completes, Vault queues the submission for import and starts the import process.
IMPORT_IN_QUEUE Submission is in queue for import.
IMPORT_IN_PROGRESS Vault is processing the submission import.
IMPORT_SUCCEEDED Submission was successfully imported and is available for viewing.
REMOVAL_IN_QUEUE Submission is in queue for removal.
REMOVAL_IN_PROGRESS Vault is processing the submission removal.
NULL Submission was successfully removed or submission upload from Vault File Manager was successfully canceled.
ERROR Submission import or removal failed, or submission reimport was canceled. See the Vault notification for details on the reason for failure.

Submissions Archive Delete Orphaned Files Job

Submission documents can become “orphaned” when a user imports them as part of a Submissions Archive dossier, then removes the submission structure. In situations like this, organizations often need to delete the documents to prevent users from referencing them. Vault can automatically delete these documents as a daily batch job. Vault can delete up to 10,000 documents each time the job runs.

Job Instance Details

Vault skips the Delete Orphaned Files job and logs it as Missed Schedule in the history if there is an import or removal job running when the orphaned files job attempts to run.

Criteria

Vault identifies documents to delete using the following document field value criteria:

  • Document Type is Submissions Archive (archive__v)
  • Document is not referenced in a binder generated from a Submissions Archive import
  • Document does not have an associated CrossLink
  • Document is not in an active workflow
  • Document is not on Legal Hold
  • Document is not associated with one or more object references
  • Document does not have unresolved annotations
  • Document was last modified more than one day ago (the Last Modified value is greater than 24 hours)

Auto-delete has the same restrictions as the standard Delete action.

Submission Archive Harmonization Job

RIM Submissions Archive includes the Submission Archive Harmonization job. When scheduled, the job corrects leaf lifecycle operations, which corrects instances when submissions have broken references. The job also corrects the eCTD submission placeholder files Vault creates when processing bulk imports asynchronously.

Job Instance Details

Vault skips the Submissions Archive Harmonization job and logs it as Missed Schedule in the history if there is an import or removal job running when the harmonization job attempts to run.

This can also occur for multiple Submissions Archive Harmonization job instances. For example, after a successful import, Vault schedules the Submissions Archive Harmonization job to run when the import queue is empty. If the daily Submissions Archive Harmonization is scheduled to run again within 24 hours, Vault updates the daily job’s status to Missed Schedule.

Errors & Limitations

File Size Limitations

Submission dossier files are subject to size limitations based upon import method:

  • When importing via Vault user interface (UI), ZIP/TAR.GZ files must be under 4GB in size. Before a ZIP/TAR.GZ file is compressed, it must be under 10 GB in size and contain fewer than 20,000 files.
  • For larger submission directories that are over 10GB in size or contain more than 20,000 files when uncompressed, you must use one of the following methods:

Import & Removal Limitations

In some cases, concurrent submission imports and removals may be in progress. Submission removals will not occur while there are ongoing submission imports for the same application.

Folder Hierarchy Import Errors

If you’ve defined folder hierarchies for submission types within your Vault, you may see import errors under the following circumstances:

  • If the Dossier Format field is populated on the Submission, but the Parameter field contains less than two (2) folder parameters
  • If the Dossier Format field is populated on the Submission, but the Parameter field references fields on objects that are not the Application or Submission object
  • If an object field specified in the Parameter field is empty or null
  • (For eCTD submissions) If the Index XML is found at the root folder and the Parameter field contains less than two (2) folder parameters, or the corresponding fields are empty or null
  • (For eCTD submissions) If the Index XML is found at the root folder and both the Dossier Format and Submission ID fields are empty
  • (For eCTD submissions) If the Index XML is found within the first two (2) folders but the Parameter field contains more than two (2) folder levels

If the corresponding values for the first two folder Parameters contain an invalid character, Vault replaces the invalid Windows folder characters with a hyphen (-) and stores the modified value as part of the source file path. You won’t see warnings or errors if this occurs.

Non-UTF-8 Characters

When importing a ZIP file, filenames cannot include non-UTF-8 characters. If a ZIP file contains filenames with these characters, you will see the following error:

The archive package did not extract successfully. To import this submission, place the folders and files in the Vault’s FTP site and restart the import.

As a workaround, you can unzip the archive and recompress it using TAR.GZ compression. You can also bypass this issue by uploading the files to your Vault’s FTP server.

Import Warning & Error Details

When you see the following warning, error, or informational messages after submission import, follow these actions to resolve issues:

Message

Type

Description

Action

STF {0} contains an empty reference and was skipped.

Warning

A Study Tagging File contains no leaf references. This may impact how the leaf displays within the Submissions Archive Viewer.

Open the referenced XML and confirm that no leaf references exist. If there are no leaf references in the XML, you can ignore the warning message. If leaf references are present, contact your Veeva representative for assistance.

An error occurred when importing the submission, document {0} id {1} from submission {2} is no longer available in Vault. Contact support for assistance.

Error

A document was deleted by a user or by Vault during an import.

Reimport the submission's dossier. If the issue persists on subsequent imports, contact your Veeva representative for assistance.

The dossier format import parameter is empty or null, {0}.{1}

Error

The fields referenced by the Dossier Format's import parameter do not contain a value. For example, the Dossier Format parameter references the application__v.folder_name__v field but the field is not populated.

Populate the fields referenced in the notification and then reimport the dossier.

Submission folder was not found, populate the submission {0} XML Submission ID field before proceeding with the import.

Error

No Submission folder is present within the ZIP/TAR.GZ package and the xml_submission_id__v field on the Submission record is not populated. Vault will attempt to use the value in the xml_submission_id__v field as the Submission folder when the ZIP file doesn't include a Submission folder and the Dossier Format is not defined on the Submission record.

Reimport the submission after making one of the following corrections:

  • Specify a Dossier Format on the Submission record
  • Select a value in the xml_submission_id__v field
  • Repackage the ZIP/TAR.GZ file to include a Submission folder

Submission folder was not found, the folder name {0} was used.

Informational

Vault applied the Dossier Format or the xml_submission_id value on the Submission record as the Submission folder because a Submission folder was not included in the imported submission package.

Confirm that the Submission folder name appears as expected. No additional action is required.

The uncompressed submission exceeds {0}GB, use Vault FTP to import larger submissions.

Error

The uncompressed ZIP or TAR.GZ file exceeds the Vault limit for uncompressed packages.

Uncompress the submission and import it via the FTP or Vault File Manager.

The uncompressed submission exceeds {0} documents, use Vault FTP to import larger submissions.

Error

The uncompressed ZIP or TAR.GZ file exceeds the Vault limit for uncompressed packages.

Uncompress the submission and import it via the FTP or Vault File Manager.

Document {0} exceeds the maximum number of object references in a field and cannot be updated.

Informational

Vault is unable to add more object references to one or more fields on the imported document. For example, the ich-ectd-3-2.dtd field already references the maximum number of Application records.

The population of the document field does not directly impact Submissions Archive functionality. If document security is dependent on these fields being populated, your Vault might need to use a different security model for these common files.

Picklist value {0} ({1}) was not created properly in {2} ({3}). Remove and re-import the submission again.

Error

The Archive Section picklist value was not successfully created during the import process.

Reimporting the submission should correct this behavior. If the issue persists on subsequent imports, contact your Veeva representative for assistance.

[{0}] (archive_status__v) is missing from the Submission object type definition. Contact the Vault administrator to update the Submission object type configuration before importing.

Error

The Submissions Archive Status field must be available on the Submission record prior to import.

Add the Submissions Archive Status field to all Submission object types and reimport the submission.

Application folder was not found, the folder name {0} was used.

Informational

Vault applied the Dossier Format value or the folder_name__v field value as the Application folder because the submission package did not include one.

Confirm that the Application folder name appears as expected. No additional action is required.

Application folder was not found, populate the application {0} folder name field before proceeding with the import.

Error

No Application folder is present within the ZIP or TAR.GZ package and the folder_name__v field on the Application record is not populated. Vault will attempt to use the value from the folder_name__v field as the Application folder when an Application folder is not included in the ZIP file and a Dossier Format is not defined on the Submission record.

Reimport the submission after making one of the following corrections:

  • Specify a Dossier Format on the Submission record
  • Select a value in the folder_name__v field on the Application record

Unsupported {0} operation on leaf {1} – {2}.

Warning

During import, Vault was unable to locate the target of the lifecycle operation. This may occur if:

  • The target leaf has not been imported
  • The path to the target leaf is invalid, for example, if the target's Application or Submission folder name is incorrect
  • The leaf ID does not exist in the target submission's XML
  • The leaf operation is considered invalid, for example, trying to replace a leaf that was already deleted by another sequence

Vault corrects some of these occurrences automatically when the target submission is imported or when the Submissions Archive Harmonization jobs completes. If this doesn't correct automatically:

  • Verify that the node displays properly in the Submissions Archive Viewer. If it does, no additional action is required.
  • Verify that the leaf exists in the target application and submission. You may need to reimport the target submission. Contact your Veeva representative to help verify the cause.

STF for study {0} references leaf id {1} that is not found in the submission.

Warning

The Study Tagging File references a leaf node that was not found within the submission's Index XML. This impacts how the STF content is displayed in the Submissions Archive Viewer.

Confirm that the leaf ID referenced by the XML is present within the Index XML. If it is, you may need to reimport the submission with the four-digit sequence ID as the Submission folder, or you may need to update the field referenced by the Dossier Format parameter with the four-digit sequence ID. If the issue persists after reimport, contact your Veeva representative for assistance.

{0} is invalid. Correct the XML and import the submission again.

Error

The Index or Regional XML is invalid against the DTD or XSD.

  • Confirm that the util folder and referenced DTD/XSD files are present.
  • Enable the Allow Imports to proceed with invalid XML setting on the Application Settings page and reimport the submission.

The DTD or schema version is not currently supported. {0}

Error

The version specified in the Regional or Index XML is not currently supported for import.

Contact your Veeva representative for information about when the version will be supported.

If an interim workaround is required, rename the Index XML and reimport the submission. If the Index XML is not found, Vault will reimport the submission as a non-eCTD.

{0} was not found. Verify the XML file is in the correct FTP location.

Error

The index references a Regional XML that is not present within the specified location.

Confirm whether the Regional XML is present in the location specified by the Index XML. If the file is present and the issue persists, contact your Veeva representative for assistance.

The XML leaf checksum does not match the file's checksum: {Title: filename, ID:}

Informational

The checksum specified in the XML or index-md5.txt file does not match the calculated checksum of the document.

If the warnings are unexpected, retrieve the submission from the source location and reimport it.
If you imported via the FTP, confirm that the FTP client was set to transfer as binary. If it was not, update the setting on the FTP client, delete the submission from the FTP, reupload the submission to the FTP, and reimport the submission.

Submission folder name does not match the Submission record name

Informational

Vault detected an inconsistency between the Submission folder and the Submission record name.

Confirm that the Submission folder name appears as expected. No additional action is required.

Application folder name does not match the Application record name

Informational

Vault detected an inconsistency between the Application folder and the Application record name.

Confirm that the Application folder name appears as expected. No additional action is required.

The following eCTD leafs were not found. Vault created a placeholder to represent each missing leaf:{Title: filename, ID:}

Informational

Vault created placeholders for missing leaf documents.

Confirm the result is as expected. If the result is not expected, confirm that all files exist within the location referenced in the XML.

This submission folder has already been used for a previous import.

Informational

Another submission within the same application that uses the same import location is being processed.

Confirm the duplicate import is intentional.

Submission folder name does not match the dossier Submission identifier.

Informational

Folder name does not match the dossier identifier.

Confirm the results are expected. If not expected, the submission may need to be reimported.

Application folder name does not match the dossier Application identifier.

Informational

Folder name does not match the dossier identifier.

Confirm the results are expected. If not expected, the submission may need to be reimported.

Submission folder name does not match the Submission record sequence number.

Informational

Submission folder name does not match the Submission record sequence number.

Confirm the results are expected. If not expected, the submission may need to be reimported.

Zero (0) KB files found and omitted from import: {IDs}

Warning

Vault detected and omitted empty files during import.

Verify the files are 0 KB. If they are not, contact your Veeva representative.

The following XML files cannot be rendered. Contact support for further assistance. {list of leaf nodes}

Warning

Vault cannot render missing leafs.

Confirm the result is as expected. If the result is not expected, confirm that all files exist within the imported archive.

An error occurred when importing the submission. The document field {field name} on document type {document type} cannot be populated.

Error

Import cannot be completed with the required field on the document type.

A required field must be removed from the document type for Vault to proceed with the import.
Type Permission Label Controls
User License Type Full User Ability to access the Import option from the Actions menu.
Security Profile Application: RIM Submissions Archive: Import Ability to access the Import option from the Actions menu and cancel in-progress submission imports or removals; ability to access the Reimport action.
Security Profile Application: RIM Submissions Archive: Import from File Manager Ability to import a submission from Vault File Manager. You also need the Submissions Archive: Import permission, but you do not need the Application: File Staging: Access permission.
Security Profile Application: File Staging: Access Ability to import submissions via the FTP.
Security Profile Object: Country: Read Ability to import a Submission where the regional XML references Countries.
Security Profile Object: Dossier Details: Read Ability to access the related Dossier Detail record that Vault creates or updates when importing a submission.
Security Profile Object: Language: Read Ability to import a Submission where the regional XML references Languages.

In addition to the permissions above, you need the Object Action: View and Object Action: Execute permissions on the Submission object to access the following actions: Remove, Import, Cancel Import, Cancel Removal, Reimport, and Cancel Upload.