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secuTrial® 4.7
DataCapture
Form functions

When changing data after setting a DEC (Data Entry Complete) a reason must be entered when
saving. This will be shown in the document history of the Audit Trail.

In the lower section of the Audit Trail you can see which entries were made when and who saved
them. If changes were made in the form, the original entries will be kept in the Audit Trail.

Hidden questions or items will be framed with a dotted line.

If configured in the FormBuilder, the column names of the items will be additionally displayed in the
AuditTrail. These are listed on the right-hand edge in grey (=colour of the status display) in a slightly
smaller font .
Note:
If a user enters or changes data without saving it, this will not be documented in the Audit Trail.

Click on CLOSE to return to the form or on PRINT to print the Audit Trail.
6.11 Electronic signature (optional)

Depending on the study, an electronic (=e-)signature may be necessary to perform a save. The save
process can encompass the saving of medical data, but it can also include actions such as reviews,
locking forms or creating comments, queries or answers to queries.
Fig. 63:
E-signature to confirm save.

The electronic signature always consists of the user's ID and password that are used for logging in
to the system.

If an electronic signature is necessary to complete the save process, the data which is to be saved
and signed will be displayed. You will then be prompted to enter your user ID and password to con firm the entries and the respective action.

If the user ID and password do not match with your data, the action will not be carried out. After
entering this information incorrectly several times, you may find that you are automatically logged
out from the system and your participant account might be de-activated. If this happens, contact
your secuTrial® administrator to reactivate your account

If the electronic signature has been performed successfully, the validity of the signature will be
checked each time the respective form is opened. If there is no valid signature, this will be indicated
in red letters at the top of the form. The information contained in the last signature (author, date,
reason) will generally be documented at the bottom of the form and shown both in the online preview
and in the print preview.

Depending on the project configuration, during certain phases of the study it may well be intentional
and legitimate for there to be no electronic signature.
6.12 Hide

After a project is setted to productive mode items, questions or forms can not be deleted anymore in
the FormBuilder. Instead they can be hidden by configuring this accordingly in the FormBuilder. The
hidden objects will not be accessible in DataCapture unless they are configured to be shown again.
As of 13/10/2014
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