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Introduction
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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
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- tab of the Study
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- Clicking on the '
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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 EventSignatures' button
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The overview shows the status of the signatures for the Processes and for the Forms.
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- 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.
Ready to sign
This overview shows the activities and forms which are ready to be signed.
Counters
Icons
Icon | Description |
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Cannot be signed off yet as the status is not clean | |
Ready for signature | |
Signed off |
Sign
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 activies/forms for signature or to make a selection of activities/forms for signature.
In order to sign a Process or Form:
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After selecting the Processes/Forms you want to sign, enter your password and click on the 'Submit signature' button.
Signing cannot be done with a temporary password
Revoke a signature
From the 'signed' view it is possible to revoke the signature of activities and/or forms which were already signed.
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 When a signature has been revoked, this will be listed in the history of revoked signatures.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
). Status colour Yellow title LINK
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 SigneeConfirmation that the form is 'signed'
- Username and role of the user who signed
- DateTime stamp when it was signed
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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 process is able to sign a process. It is possible to sign a process when the process is closed (see Processes and Study Flowclosed (
). Status colour Yellow title LINK
When a process is signed, the following information will be clearly visible for the process:
- Signature with Username and role of the user who signed --> Name of the User?
- Role of the Signee
- DateTime stamp when it was signed
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Overview