Viedoc Share

  • Published by Viedoc System 2024-12-03
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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 - a digital 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 can share documents if the eTMF manager assigns one of the following permissions to their role:

  • Manage document sharing for Viedoc Clinic users
  • Manage document sharing for Viedoc Me users ​​​​​

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 assigns permission to an eTMF user to Manage document sharing for Viedoc Clinic users and/or Viedoc Me users. 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
    • (Optional) Adds document fields
    • 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, complete fields, and/or and sign the document using a one-time code.
  5. For Viedoc Me users, a link to Viedoc Share is also available under Documents on the main page of Viedoc Me.
  6. If a co-signatory is required, after all recipients have completed required fields and signed the document, the co-signatory receives an email that the document ha been signed by the recipient, then also signs it.
  7. The signed documents are included in the corresponding side of the eTMF-EMS archive (Investigator and/or Sponsor).

Configuring a document for sharing

An eTMF user with WRITE access to a document must enable the sharing before other TMF end users can share the document.

To configure a document for sharing:

1 In the Trial Master File view, navigate to the unpublished document in the TMF structure.
2 Select the document to open the Document properties window.
3

In the DOCUMENT SHARING section, select the users that the document can be shared with - Viedoc Clinic users or Viedoc Me users.
4 Select Publish or Save as unpublished, depending on your needs.

Note! Only an unpublished document can be configured for sharing or have document fields added (see next section below). If a document has already been published and/or finalized, you can create a new version of the document, configure for sharing and/or add document fields, then publish and finalize again.

Adding document fields

Fields such as radio buttons or open text fields can be added to an unpublished document once it has been added to an artifact. These fields can be customized and set as optional or required for the recipient. If fields are set as required, the recipient cannot sign the document until all required fields have been completed.

To add fields to a document:

1 In the Trial Master File view, navigate to the unpublished document in the TMF structure.
2 Select the document to open the Document properties window. Select the eye icon to open a preview of the document.
3

On the far left of the document, the options for adding/editing fields are displayed:

To create a Radio Button:

1

Select Radio Button:
2

Drag the cursor to create the field shape (size and position can be edited later).
3

Once the shape is created, an edit window is displayed:

1. To name the radio buttons, click inside the text box to the right of Field Name and type the name (for example "Question 1". Then select the option that appears below to create the field name.

Note! For radio buttons to function properly, options belonging to the same question must have the same field name. For example, both "yes" and "no" radio buttons belonging to the first question must both be named "Question 1", and the next set of "yes" and "no" radio buttons belonging to the second question must both be named "Question 2".

2. Setting the field as Read Only will not allow the recipient to select or deselect the button

3. Setting the field as Required will prevent the recipient from signing the document until all required fields have been completed.

4. Setting the Size controls the size of the radio button

5. Selecting Document Field Indicators and typing in a label creates a flag to the left of the field that the recipient will see. Note! This may not be visible if the recipient is viewing the document on a mobile device.
4

Once all of the desired fields and settings have been completed, select save.

To create a Text Field:

1

Select Text Field:
2

Drag the cursor to create the field shape (size and position can be edited later).
3

Once the shape is created, an edit window is displayed:

Edit options for the text field as needed:

1. To name the text field, click inside the text box to the right of Field Name and type the name (for example "TextFormField 1"). Note! Text field names do not affect the functionality as the radio button names do.

2. Entering a Default Value will autofill the text field with any text you enter here.

3. Setting the field as Read Only will not allow the recipient to type any text in the text field.

4. Setting the field as Multiline will allow for multiple lines of text to be entered.

5. Setting the field as Required will prevent the recipient from signing the document until all required fields have been completed.

6. Setting the size controls the size of the text field

7. Selecting Document Field Indicators and typing in a label creates a flag to the left of the field that the recipient will see. Note! This may not be visible if the recipient is viewing the document on a mobile device.
4

Once all of the desired fields and settings have been completed, select save.

Note! Document fields and settings may be changed while a document remains unpublished. Once a document is published, fields may not be edited or added.

Sharing a document

To share a document with a Viedoc Me user or a Viedoc Clinic user:

1 In the Trial Master File view, navigate to the finalized document in the TMF structure.
2 Select the document to open the Document properties window.
3

In the Sharing section at the top of the window, select ... to open the Sharing window.
4 Select Create a new binder.
5

Select Recipients > Viedoc Me users or Viedoc Clinic users.
6

In the field just below, select the users that you want to share the document with.

Note! If you select more than one user, the option Create a separate binder for each recipient will be automatically selected and non-editable. This is because the recipients should not share any study information with each other.

Note! You can only select users within the same scope as yourself.

Note! If the document is included in an artifact that is only on the Sponsor side of the TMF (or on neither Sponsor nor Investigator side), and the document version is set to be shared with Viedoc Me users, it is not possible to collect signatures. This is because the signatures can include information that can jeopardize the data integrity of the Viedoc Me users.
7 For the Signing option, select whether or not to request a signature.
8 If you selected Yes in the previous step, select a signature reason.
9

Select whether or not a co-signatory is required.

Note! The co-signatory cannot sign the document if you selected No in step 7.
10

Select the co-signatory or co-signatories.

Note! You can only select users within the same scope as yourself.
11 Select a signature reason for the co-signatory.
12 Select Continue to see an overview of the sharing details.
13

If the sharing details are correct, select Confirm.

Otherwise, you can select Back and edit.
14 After confirming, a binder summary is displayed and an email is sent to each of the recipients with a link to Viedoc Share where the document can be viewed and/or signed.

Viewing the binder properties

1 In the Trial Master File view, navigate to the document.
2 Select the document to open the Document properties window.
3 In the Sharing section at the top of the window, select ... to open the Sharing window.
4

Select the arrow icon to open the Binder properties window.
5

The binder properties are displayed, including the history with all actions for the binder.

Downloading the document

To download the shared document from the binder:

1 In the Trial Master File view, navigate to the document.
2 Select the document to open the Document properties window.
3 In the Sharing section at the top of the window, select ... to open the Sharing window.
4

Select the arrow icon to open the Binder properties window.
5

In the top right corner, select ... to open the binder menu.
6
  • The menu item Download original file downloads the original file to your computer.
  • The menu item Download with sharing details downloads a zipped folder to your computer. The zipped folder contains the original file and a PDF with the sharing details.
  • The menu item Download with signatures downloads a PDF file to your computer. This menu item is only available if all recipients and co-signatories have signed the document. The PDF contains the original file and a cover page with the signatures. This is an example of such a cover page:

Revoking a binder

A binder can be revoked if you want to share a newer version of a document or to cancel the sharing when a document version has been shared by mistake.

Note! If the document in the binder has been signed, even if it's by only one recipient, the binder cannot be revoked.

To revoke a binder:

1 In the Trial Master File view, navigate to the document.
2 Select the document to open the Document properties window.
3 In the Sharing section at the top of the window, select ... to open the Sharing window.
4

Select the arrow icon to open the Binder properties window.
5

In the top right corner, select ... to open the binder menu.
6 Select Revoke sharing.
7

The binder properties are displayed, and you can now see that the binder is revoked.

The Sharing section in the Document properties window

An eTMF user with Manage sharing permission will see a Sharing section at the top of the Document properties window.

1. The number of active shared binders accessible by the Sharer.

2. The number of pending actions for binders accessible by the Sharer (only displayed if the number is greater than 0).

3. The number of actions done for binders accessible by the Sharer (only displayed if the number is greater than 0).

4. Select ... to open the Sharing window with an overview of the existing binders. This is also where new binders can be created.