So, how does it work? And how is it different from the standard form-based audit trail? Typically, the audit trail is updated using the date/time that the form was saved as the entry/modification time for each field on the form. With field-by-field, the audit trail is updated whenever the user navigates away (e.g., tabs) from a field – which is much more granular.
Isn’t updating the audit trail for each field when the form is saved good enough? Let’s take a walk down memory lane and think about the old paper process.
In the good (?) old days, if an investigator made a spelling error, he/she would have been obligated to correct and annotate the spelling error on the paper form to maintain attributability and accuracy (remember ALCOA). With a form-based audit trail, the user may make as many corrections/changes as they wish before saving the form to the study database – and no attribution for those changes is required. In cases like this, more information is collected about data changes when paper is used as opposed to an electronic data capture platform.
Another benefit of the field-by-field model is that monitors have visibility into the order in which data was entered. This allows monitors insight into whether protocol procedures have been followed – and they can see when observations or procedures were done out of order.
Monitors can also see when data was not entered in a contemporaneous fashion. Consider the case where investigators/treatment dispensers are required to enter the time an even occurred – but the audit trail shows it was recorded minutes or even hours later.
While regulators are increasingly becoming enamored of the field-by-field audit trail, site personnel have a very different opinion. Their perspective is understandable. With field-by-field sites are forced to slow down and enter change reasons for every typo they correct.
This debate leaves Sponsors/CROs in a quandary. Do they adopt a field-by-field audit trail before it’s required and get sites used to the new paradigm? Do they cater to regulators or prioritize the site’s user experience? We’ll let you guess who wins that tug-of-war.
Bottom Line: VISION supports both field-by-field and form-based audit trails – so the choice is yours.