...

• Auto queries are generated on the corresponding eCRF in case of inconsistencies,
• The form becomes available for signature when submitted and no issues are discovered.

...

Options

Form

Image Added

Audit trail

On form level more or less the same options are available as on event level.

The user can access the audit trail  via the Image Added icon. The audit trail will display all actions up to that specific level.

Comment

The comment icon will display the number of comments already added on that specific location. Comments can be created by all users with management rights on the eCRFs, meaning for regular a CRF this would be both the site and the sponsor.

Image Added

Delete

A user can opt to remove the form data. When removing data a reason has to be documented.

Query

•  Query on event level should show up (screenshot to be replaced)

...

Itemgroup

Item

Edit data

After submission it is possible to modify or clear the data, but the system will request to document a reason.

Image Added

Image Added

Specific situations:

• In case a new question was added to the design of the eCRF after submission of such eCRF, it will appear on the submitted eCRF and can be completed without documenting a reason.
• In case an existing question has been disabled after submission of the eCRF, the field will be locked for editing and any outstanding queries will be closed automatically.