Completed forms may only be edited by users with administrator accounts or investigator accounts when the investigator edit setting is turned on. Forms are edited by clicking on the Edit link next to the selected form shown on the patient details screen, or by clicking on the Edit this form link shown when viewing a form. The form is displayed in the same way as when adding the form but with some extra fields for recording validation status and reason for editing. The user may change any of the values in the form and they must complete the reason for editing field before reviewing and saving the form.
Editing a form
When editing a form, the validation status can be set to ‘Validated’ provided there are no open queries for the form. Once a form is marked as validated, a green tick appears next to the form name in the patient details. If a query is added to the form after the form has been marked as validated, the validation status will automatically be changed to ‘Not validated’. It is up to the trial coordinating team to decide what constitutes a validated form. It may, for instance, be as a result of a formal monitoring visit, or alternatively visual check against the source data by someone who did not enter the data.
Completed forms may not be deleted unless the form delete setting is turned on. As an alternative, the validation status may be set to ‘Data unusable’ to indicate that the whole form should be disregarded at the analysis stage.