Vault eTMF users may upload a large number of documents frequently. The TMF Bot can automatically classify new documents, saving your organization time and effort. Auto-classification with the TMF Bot can help reduce the number of classification errors, and surface potential issues sooner, thus increasing compliance. The TMF Bot can also automatically set the Study value for documents.

If configured to use TMF Bot for auto-classification, Vault will analyze documents added to the Document Inbox and populate their Document Type, Subtype, and Classification fields, with the current status of each document listed in the TMF Bot column. This column is empty when TMF Bot is not enabled.

Once this auto-classification is complete, you have the chance to review the classification before completing and removing it from the Document Inbox.

If configured to use TMF Bot for study metadata extraction, Vault automatically populates the Study field on documents, including any documents created via email processors or API.

How to use Auto-Classification

Once an Admin has deployed a Trained Model in your eTMF Vault, no additional action is needed on your part. The following methods of adding documents to the Document Inbox result in auto-classification or automatic population of the Study field by the TMF Bot:

  • Uploading a document normally and selecting Classify documents later
  • Dragging and dropping documents into the Document Inbox
  • Uploading via Vault API
  • Uploading via Vault Loader
  • Uploading via FTP
  • Uploading via Vault Mobile
  • Documents created via Email Ingestion

The TMF Bot then follows these steps to queue, auto-classify, and automatically populate the Study field on uploaded documents:

  1. Vault checks the origin of each file and assigns it to a classification queue:
    • Documents uploaded via API, Vault Loader, FTP, or email are placed in a bulk processing queue, ensuring that large imports do not slow down typical auto-classification processes.
    • All other documents, including those uploaded via Vault Mobile, are placed in an express processing queue.
  2. The TMF Bot automatically scans each added document. If you navigate to the Document Inbox, you can see the progress for each document in the TMF Bot field. If you cannot see the TMF Bot field, you can add it as a column in your Document Inbox. Each document will list one of the following statuses:
    • Express Queued…: The TMF Bot is waiting to process the document from the express queue.
    • Bulk Queued…: The TMF Bot is waiting to process the document from the bulk queue.
    • Done: The file has finished processing.
  3. If the TMF Bot can auto-classify the document, the document has its Type, Subtype, Classification, or Study fields populated, and the Tags field will include the TMF Bot Auto-classified tag.
  4. If a Study Metadata Extraction model is deployed, the TMF Bot scans the file name and content to identify a match with an existing study in your Clinical Operations Vault. If there is a match, and if the user has permissions for that Study, the TMF Bot populates the Study field on the document. If the TMF Bot does not identify a match, or if the user does not have permissions for the matching Study, the TMF Bot does not put anything in the Study field for that document.

While the time to process each document can vary, Vault aims to have each file processed in five (5) seconds.

Accepting Auto-Classifications

Once documents have a value of Done in the TMF Bot field, use the checkboxes to select auto-classified documents, then click Complete to enter any necessary document fields. Note that you can only complete documents with the same classification in bulk.

Once completed, the uploaded documents are available for additional processing. The document is also tagged as TMF Bot Auto-classified.

Rejecting an Auto-Classification

If you find that TMF Bot applied an incorrect classification, you can navigate to the document and select Reclassify as normal. When you manually reclassify a document, Vault tags the document as TMF Bot Misclassified.

Auto-Classification Limitations

  1. Some document classifications may not be available to the TMF Bot. This is often because there were not enough documents to train the TMF bot on that classification.
  2. The TMF Bot only auto-classifies documents if it is confident in its selection. Documents typically have low confidence when the document could easily be classified as two or more different document types.
  3. Some categories of documents cannot be auto-classified. These include:
    • Audio or Video files
    • Non-text files, such a ZIP files, statistical files, or database files
    • Non-English files
    • Files where Vault cannot extract text, for example, if the text is too blurry.