Managing Documents

The key tasks for study contributors involve document management:

  • Creating and classifying documents
  • Approving documents

Adding Documents Using the Document Inbox

The Library includes the Document Inbox view, which allows you to drag and drop documents to upload to Vault. This is the fastest way to incorporate completed documents into a study. When you drag and drop a file into the Document Inbox, Vault uploads the file as an unclassified document.

For Vaults with more than 1,500 classified and approved documents, Vault automatically classifies new documents based on your existing document classifications. If Vault has classified a document incorrectly, you can manually reclassify the document. Vault’s automatic classification accuracy improves over time based on new documents you have added and classified, as well as documents you have manually reclassified.

Complete the following steps to add and classify documents:

  1. Navigate to TMF Workspace > Library > Document Inbox.
  2. Access the folder on your computer which contains documents you would like to add.
  3. Drag and drop the desired files. You can upload up to 250 documents at a time.
  4. Use the Bulk Apply Fields dialog box to link related docs to a single study. Otherwise, upload the documents and link them to the appropriate study individually. The system notifies of successful uploads.
  5. Navigate to the Library to access the uploaded documents.
  6. Select a document to classify.
  7. Complete the required fields and save. The document is now In Progress.

Alternatively, you can use the Collaborative Authoring feature to edit a document or template that has already been added.

Approving Documents

You can move an In Progress document through a desired approval workflow:

  • Promote to Approved: documents that do not need review before approval
  • Send for QC: documents that should be routed to other contributors for review before approval
  • Send for eSignature: documents that require a review and signature before approval

Promoting Documents to Approved

  1. From the Library tab, select an In Progress document.
  2. From the Workflows menu, select Promote to Approved. The system displays a dialogue box.
  3. In the Change Document Status dialogue, select Yes to confirm this approval.

Your document is now in the Approved state.

Sending Documents for Quality Control Review

  1. From the Library tab, select an In Progress document.
  2. From the Workflows menu, select Send for QC. The system displays a dialogue box.
  3. In the Start Workflow dialogue, select a study team member or members to review the document.
    • If desired, include any instructions for the reviewers to follow.
  4. Type the required Due Date and click Start to begin the QC workflow.

The reviewers can now access the document from their task list to complete the document review.

Performing QC Reviews

Only one reviewer can complete the review actions on a document.

  1. From the Home tab, select the desired document to review.
  2. Click Continue and then Accept to access the document.
  3. If there are no issues, click Pass and then Complete to approve.
  4. If there are issues with a document, you must create a Quality Issue and assign it to the appropriate person to correct the issue.
  5. Complete the required fields and click Save.
  6. Click Complete and select Not Passed. The selected user should review and resubmit in the QC workflow.

Send Documents for eSignature

  1. From the Library tab, select an In Progress document.
  2. From the Workflows menu, select Send for eSignature. The system displays a dialogue box.
  3. In the Start Workflow dialogue, select a study team member or members to sign the document. Each selected team member will receive a Task notification and can now access the document from their task list to complete the document review.

Reviewing Documents

  1. From the Home tab, select the desired document to review.
  2. Click Continue and then Accept to access the document.
  3. If there are no issues, click Approve.
  4. Fill out the required fields to populate your electronic signature and then Complete to approve.

All reviewers must approve and sign a document for it to reach the Approved state. If any reviewer rejects the document, it returns to the In Progress state and must be corrected and re-circulated.

For additional information on your study, you can review the status of all documents using the TMF Reports and Dashboards.