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Introduction
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Introduction
Clinical data, both eCRF and activities, need to be signed off by the person
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authorized to confirm that the data is correct.
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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.
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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
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 | 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 When a signature has been revoked, this will be listed in the history of revoked signatures.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
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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
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. If a signed
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form is modified, the signature of the
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form will be overridden (revoked) and the form needs to be signed again. In case a modification was performed on the
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form, it is clear on the
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form that a new signature is needed. It is also clear for the user in the signature page that
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forms need to be resigned although they were already signed before.
Manual revoke
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
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Overview
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
