Audit trail review

Signals from the audit trail of the study worth a look, critical data first: what each one means, how to mark it reviewed or raise a query, and the lock readiness item.

The audit trail of a study records every value entered or changed: who, when, the old and the new value and the reason. ICH E6(R3) asks that the audit trail of critical data is reviewed periodically and in proportion to the risks (Annex 1, chapter 4 “Data governance”: metadata, including audit trails, and their review), and the EMA guideline on computerised systems and electronic data in clinical trials says the same. Reading tens of thousands of records by hand is not possible, so Audit trail review turns the trail into signals: patterns worth a look, critical data first, each with its evidence.

A signal is not a finding and never an accusation. Most have a simple explanation: a correction from the source, a late laboratory result, a coordinator back from leave. The review documents that someone looked, what they saw and what they did.

Who sees it

Open Audit trail review in the study menu. The page is for the project administrator, the data managers and the monitors; the site team and the sponsor's viewers do not see it. Each person sees the signals of their own sites only. A blinded member never sees the forms for the unblinded team, and the review never reads the records of randomisation and unblinding.

What is looked at

• Changed after SDV, after the investigator's signature, after the data manager's approval or after the form was unlocked: a value replaced or removed while the form stood verified, signed, approved, or after the data manager unlocked it. A value added to an empty field is not counted.
• Entered long after the visit: the first entry of a form by the site more days after the visit than the setting allows (14 by default). The visit date is the date recorded for the visit, else its planned date.
• Changed many times: one value changed three times or more (a setting).
• Entered at night or at the weekend: in the time zone of the site, else of the study; the night hours are a setting.
• Many forms in a few minutes: one person saved eight forms or more within ten minutes (both are settings).
• Changed by someone other than who entered it and Entered by an unusual role: by default only investigators enter the site's data.

The patients' own answers (ePRO), imports and data moved from another system are not counted as the site's habits (late entry, night, bursts, another person, role); their changes after SDV, signature, approval or unlock are counted.

Critical data first

A signal is on critical data when its field is marked critical in the eCRF builder, or, for a signal on a whole form, when the form has a critical field or the SDV plan asks 100% SDV of it at that visit. These signals come first, with their own progress tile; the rest follows.

Review a signal

1. Click a signal. The evidence shows each record in the site's time: who, their role, the event, the field, the value before and after, and the reason. Grey rows marked “before” are the context, such as the SDV or the signature that came before the change.
2. Open the form and its history shows the form with the full history of that field.
3. When the change is explained, write a comment if you wish and press Mark reviewed (project administrator, data manager).
4. When the site has to explain or correct, edit the text and press Raise a query. The query is the same as one raised on the form; the signal is then shown as “Query raised” with its number. Monitors can raise queries from here too.

A review mark covers the item up to its last change. If the value or the form changes again later, the signal is open again and counted in the tile of the same name. Every mark and query is a record in the audit trail of the study, on the same patient and form.

Filters, progress and Excel

Filter by site, signal, state (open, reviewed, all), the period of the last event and critical data only. The tiles show how many signals on critical and on other data are reviewed. Excel downloads the signals as filtered, their evidence and the settings, for the trial master file or the data review meeting; the download is in the audit trail.

Settings

The project administrator and the data managers set the days for late entry, the number of changes, the night hours and whether weekends count, the burst (forms and minutes), the roles that usually enter data and the time zone of the study and of single sites. Every change of the settings is in the audit trail.

Lock readiness

In Lock readiness of the study the item “Audit trail of critical data reviewed” follows this page by itself: in progress while some signals on critical data are reviewed, done when all of them are, with the name of the last reviewer and the time. A study with no signals on critical data keeps the item by hand.