Introduction

Clinical data, both eCRF and activities, need to be signed off by the person

authorized to confirm that the data is correct.

Overview of signatures

 The overview of the signatures can be found byVista 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 to the clinical data at each form and activity. 

 Signature status on form level

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 Signature status on activity level

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Navigation

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

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

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• column in the study view listing all subjects

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

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Signatures

There are 3 views overview in the signatures overviewsection:

• Ready to sign
• Not signedready to sign
• Signed

For each view overview both the available activities and forms are shown. The Clicking on the activity name and the form name is a hyperlink and by clicking on the link the user is directed allows the user to easily navigate to the particular activity/form.

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

Ready to sign

This The first overview shows the 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, the name of the form, the event and eventually the eventgroup to which the form belongs, is displayed. The history shows the revoked signatures.

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Not

ready to sign

This overview shows the activities the activities and forms which are not yet signed. It includes both the activities/forms which are owned by that user and are not 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.

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Signed

This overview shows the activities the activities and forms which are owned by that user and signed. The DateTime The DateTime stamp when the activity/form was signed and the Username 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.Image Removed

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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)sign
• signed

is shown.

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Signing

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 which are not selected).

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

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  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 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.

Manual revoke

After a(n) acitivityactivity/form has been signed, a user can manually revoke the signature if the user is the owner of the activity/form.From  From the 'signed' view it is possible to revoke the signature of activities and/or forms which were already signed by clicking on the Image Modified in the 'Revoke' column and confirming documenting the actionreason to revoke.

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Automatic revoke

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

• UUID: unique ID number of the revoke
• DateTime stamp when the activity/form was signed
• Username and role of the user who signed
• DateTime stamp when the activity/form signature was revoked
• Revoked reason: manual or automatic

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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" (

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

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

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 (

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

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

Summary

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Summary

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