Introduction 

Clinical data, both eCRF and activities, need to be signed off by the person authorized to confirm that the data is correct. Vista Trials collects electronic signatures and is 21 CFR part 11 compliant. Users with specific access to the signatures are able to navigate to the signature section and can view and/or edit depending on the authorization defined on the delegation log.

The signature status is visible for all users with at least read access. 

 Signature status on form level

 Signature status on activity level

Navigation

Navigation to the signatures section can be done in 2 ways:

• Clicking on the 'Signatures' button in the actions column in the study view listing all subjects

• Clicking on the 'Signatures' button displayed in the study flow or data section when the subject has been accessed

Signatures

 There are 3 overviews in the signatures section:

• Ready to sign
• Not ready to sign
• Signed

For each overview both the applicable activities and forms are shown. Clicking on the activity name or the form name allows the user to easily navigate to that particular activity or form.

 The signature section only displays forms and activities and allows signing of these, if owned by the user. The user has no signature access to data coming from another origin.

Ready to sign

The first overview shows all activities and forms which are owned by that user and are ready to be signed.

For activities, the name of the activity is displayed. For forms, it will display the name of the form, the event and if applicable, the EventGroup, to which the form belongs. The history shows the revoked signatures.

Not ready to sign

This overview shows the activities and forms which are owned by that user and are not ready to be signed. 

For activities, the name of the activity is displayed. For forms, it will display the name of the form, the event and if applicable, the EventGroup, to which the form belongs. The history shows the revoked signatures.

Signed

This overview shows the activities and forms which are owned by that user and signed. The time stamp when the activity or form was signed and the name and role of the user who signed are shown. 

For activities, the name of the activity is displayed. For forms, it will display the name of the form, the event and if applicable, the EventGroup, to which the form belongs. The history shows the revoked signatures.

Counters

On each view the counters of signatures are shown. For both the activities andforms the counts of:

• Ready to sign
• Not ready to sign
• Signed

are shown.

Signing

Closed activities and submitted forms with status 'no issues' show up in the signatures section as ready to be signed. 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 how many are not selected). Signing will be done by entering the user email and password, and clicking the 'Submit Signature' button.

  Signing cannot be done with a temporary password

Revoke a signature

 Signing a form/activity does not lock the form/activity. 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 (revoked) and the form 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 need to be resigned although they were already signed before.

Manual revoke

 After a(n) activity/form has been signed, the 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 documenting the reason to revoke.

Automatic revoke

Signatures can also get revoked automatically by the system. For forms this will happen when the data on the form is edited or when the form is deleted after the form has been signed. A signature linked to an activity will automatically be revoked when the activity data is changed. This occurs when the activity is reset, restarted, deleted (by restarting/resetting or changing the actual arm of a previous activity) 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 in the history of the revoked signatures:

• Date and time stamp when the activity/form was signed;
• Username and role of the user who signed;
• Date and time stamp when the activity/form signature was revoked;
• Reason for the revoke.

Summary