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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. The activity name and the form name is a hyperlink and by clicking on the link the user is directed to the particular activity/form.


Ready to sign

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

For activities, the name of the activity is displayed. For forms, the name of the form, the event and eventually the eventgroup to which the form belongs is displayed. The history shows the revoked signatures.


Not signed

This overview shows the activities and forms which are not yet signed. It includes both the activities/forms which are ready to be signed and the ones which are not yet ready to be signed.

For activities, the name of the activity is displayed. For forms, the name of the form, the event and eventually the eventgroup to which the form belongs is displayed. The history shows the revoked signatures.


Signed

This overview shows the activities and forms which are signed. The DateTime stamp when the activity/form was signed and the Username and role of the user who signed are shown. 

For activities, the name of the activity is displayed. For forms, the name of the form, the event and eventually the eventgroup to which the form belongs is displayed. The history shows the revoked signatures.

 

Counters

On each view the counters of the signatures are shown. For both the activities and the forms the count of the 

  • ready to sign
  • cannot be signed (not yet ready to be signed)
  • signed

is shown.

 

 

Signing

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 activities/forms for signature or to make a selection of activities/forms for signature.

At the bottom of the signature page there will be a summary of the number of activities and forms which have been selected for signature (and which are not selected).

 Signing will be done by entering the user email and password and clicking the 'submit signature' button.

  (warning) Signing cannot be done with a temporary password


Revoke a signature

Manual revoke

After a(n) acitivity/form has been signed, a user can manually revoke the signature if the user is the owner of the activity/form.

From the 'signed' view it is possible to revoke the signature of activities and/or forms which were already signed by clicking on the  in the 'Revoke' column and confirming the action.

 

Automatic revoke

Signatures can also be automatically revoked by the system. For forms this will happen when the data on the form are edited after the form has been signed. Process signatures will be automatically revoked when the process data are changed. This occurs when the process is reset, restarted, deleted (by restarting/resetting or changing the actual arm of a previous process) or when the actual arm has been changed.

 

History of revoked signatures

To see the history of the manually and automatically revoked signatures, the user needs to click on the  button in the 'History' column. The number between brackets shows the number of revokes that were done for that activity/form.

The following parameters will be shown 

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?).

  

 

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
     
(warning) 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

      
(warning) 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.

 

Summary

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