Content

Introduction

Description

Clinical data need to be signed off by the person responsible for the data to confirm that the data is correct. In Vista Trials, signing will be done by entering the user login (email + password) for a second time.

Overview of signatures

The overview of the signatures can be found by:

Clicking on the 'Signatures' button in the actions column in the Subjects tab of the Study

Clicking on the 'Signatures' button when the Subject has been accessed

There are 3 views in the signatures overview:

Ready to sign
Not signed
Signed

For each view both the available activities and forms are shown.

Ready to sign

This overview shows the activities and forms which are ready to be signed.

Counters

Icons

Icon	Description
	Cannot be signed off yet as the status is not clean
	Ready for signature
	Signed off

Sign

From the 'ready to sign' and the 'not signed' view it is possible to sign off activities and/or forms which are ready to be signed (closed activities and submitted forms with status 'no issues'). It is possible to select all activies/forms for signature or to make a selection of activities/forms for signature.

In order to sign a Process or Form:

Select the tickbox in the 'Sign' column
OR select the tickbox 'Select all processes/forms for signature'
OR select the tickbox 'Select all forms ready to sign in the event' (only applicable for Forms)

After selecting the Processes/Forms you want to sign, enter your password and click on the 'Submit signature' button.

Signing cannot be done with a temporary password

Revoke a signature

From the 'signed' view it is possible to revoke the signature of activities and/or forms which were already signed.

In order to revoke a signature, click on the revoke button in the 'Actions' column and confirm that you want to revoke the signature. When a signature has been revoked, this will be listed in the history of revoked signatures.

History of revoked signatures

To see the history of revoked signature, click on the 'History' button in the 'Actions' column. You will see when and by who the signature was done and on which date the revoke was done with the reason (manual versus automatic?).

Go to

With the 'Go to' button you will be directed to the Process/Form linked to that record.

Signature of a Form

Only the Owner of the Form is able to sign a Form. It is possible to sign a Form when the Form is submitted and when the validation status of the form is "No issues" (LINK).

When a Form is signed, the following information will be clearly visible on the Form:

Confirmation that the form is 'signed'
Username and role of the user who signed
DateTime stamp when it was signed

Signing a Form does not lock the form. Queries can still be made and modifications can still be done: if a signed Form is modified, the signature of the Form will be overridden and needs to be signed again. In case a modification was performed on the Form, it is clear on the Form that a new signature is needed. It is also clear for the user in the signature page that Forms needs to be resigned although they were already signed before.

Signature of a Process

Only the Owner of the process is able to sign a process. It is possible to sign a process when the process is closed (LINK).

When a process is signed, the following information will be clearly visible for the process:

Username and role of the user who signed
DateTime stamp when it was signed

Signing a process does not lock the process. When a process is signed and edited, the signature of the process will be overridden and needs to be signed again. In case a modification to the process is done, it is clear in the process that a new signature is needed. It is also clear for the user in the signature page that the process needs to be resigned although it was already signed before.

Signatures