Viedoc Share for the eTMF Manager

  • Published by Viedoc System 2024-10-11
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Introduction

The Viedoc Share feature is available to eTMF users for sharing documents with Viedoc Me users or Viedoc Clinic users for information sharing or for collecting signatures.

Definitions

These concepts are used in the following text:

  • Sharer - an eTMF user with Manage sharing permission
  • Binder - an envelope that includes a finalized document version that is filed to the eTMF
  • Recipient - a Viedoc Clinic or Viedoc Me user from the same scope as the sharer
  • Co-signatory - a Viedoc Clinic user from the same scope as that sharer. The co-signatory can sign a document when all the binder's recipients have signed it.

Prerequisites

An eTMF user with the permission Manage document sharing for Viedoc Clinic users or Manage document sharing for Viedoc Me users can share documents. The permissions associated with your user role are set up by the eTMF Manager.

A document can only be shared if:

  • the corresponding artifact has been configured for sharing (done by the eTMF Manager)
  • the document is finalized
  • the Sharer has permissions for the same scope (trial, country, site) as the Viedoc Me user or the Viedoc Clinic user

Workflow

  1. Viedoc Admin: An Admin user maps the permission to Manage document sharing with Viedoc Clinic and Viedoc Me users to an eTMF user. This is the Sharer.
  2. Viedoc TMF > TMF Admin view > Edit artifact. The eTMF Manager enables document sharing for Viedoc Clinic and/or Viedoc Me users.
  3. Viedoc TMF > Trial Master File view > Document properties. A user with WRITE access:
    • Configures a document to be shared with either Viedoc Clinic users or Viedoc Me users
    • Publishes and finalizes the document
    • Creates binder(s) and shares them with recipients and co-signatories
  4. Recipients receive a an email with a link to Viedoc Share where they can read and/or sign the document using a one-time code.
  5. For Viedoc Me users, a link to Viedoc Share is available under Documents on the main page of Viedoc Me.
  6. When all recipients have signed the document and if a co-signatory is required, the co-signatory also signs it.
  7. The signed documents are included in the corresponding side of the eTMF-EMS archive (Investigator and/or Sponsor).

Enabling document sharing for an artifact

To enable document sharing for an artifact:

1 In the TMF Admin view, when maintenance mode is activated, select the Edit button that appears when you hover over an artifact in the TMF structure.
2 In the DOCUMENT SHARING section of the Edit artifact window, select the users that the artifact can be shared with - Viedoc Clinic users, Viedoc Me users, or both.
3 Make sure all required fields are filled in, and select Save.
4 Select Apply all changes and to make the change take effect.