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 password for a second time.

Overview of signatures

The overview of the signatures can be found in the Subjects tab of the Study by clicking on the 'Signature' button in the actions column.

The overview shows the status of the signatures for the Processes and for the Forms.

Status: Clean, missing, issues? - What will be displayed for processes?

For the Forms, signatures can be done on 3 levels:

Select all forms for signature
Select all forms ready to sign in an Event
Select individual Forms in an Event

Icons

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

Sign

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.

Revoke a signature

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 When a signature has been revoked, this will be listed in the history of revoked signatures.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 (see /wiki/spaces/VTDOC/pages/16587063545) 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" (see /wiki/spaces/VTDOC/pages/16587063594).

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

Signature with who signed --> Name of the User?
Role of the Signee
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

The same Priniciples as for a Form shall be used, with the difference that a process gets Closed and not Submitted --> to be checked if the following is correct based on this statement:

Only the Owner of the process (see /wiki/spaces/VTDOC/pages/16587063545) is able to sign a process. It is possible to sign a process when the process is closed (see Processes and Study Flow).

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

Signature with who signed --> Name of the User?
Role of the Signee
DateTime stamp when it was signed

Signing a process does not lock the process. When a process is signed and reset, the signature of the process will be overridden and needs to be signed again. In case a reset 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.

Copy of Signatures