Export the audit trail

The audit trail can be not only read on screen but also taken away as a file — for a sponsor audit, an answer to an inspection request or an archive. The server builds the document with exactly the filters selected on screen.

Who and when

QA & inspection Data manager — you need both permissions on the study: reading the audit trail (audit.read) and running exports (export.run). A view-only auditor reads the trail on screen but does not export files.

An export is needed when the trail must be handed over or kept outside the system: one subject’s history for an inspection request, a site’s trail for a period for an audit, a CSV for independent chain verification.

Before you start

• You hold audit.read and export.run on this study.
• Decide on the cut: the whole study, one site or one subject, for which period, by which user or action.
• If you need the full evidence set for an inspection (trail, anchors, access, design versions), assemble the inspection packet instead.

Steps

1. Open the study → Audit trail. To export one subject’s trail, open that subject’s page and its audit tab — the rest is the same.

2. Set the cut: Site (or “Whole study”), and under Filters — the period From / To, Who, Action, What changed. The table shows exactly what goes into the file.

3. Open the Export menu above the table and pick a format:

   • Export XLSX — a register to read and work with in Excel;
   • Print PDF — a printable PDF/A copy;
   • CSV for verification — a dynamic file with integrity-chain links for independent verification.

4. Wait for the document to be prepared — the file downloads.

What happens

• The build lands in the study’s Exports journal with its checksum; every download is recorded in the audit trail.
• The first XLSX sheet is “About this export”: study, scope (whole study, site or subject), period, user and action filters, data cut, number of records, how many blinded values were masked, who generated it and when.
• Values of blinded fields are masked exactly as on screen unless you hold the unblinded-data permission (data.unblinded.read).
• No data in the system changes.

If it doesn’t work

• No Export menu — you lack audit.read or export.run on the study. The menu exists only on the study and subject trails; the whole-organization trail (Admin → Audit trail) has no file export.
• “Could not prepare the document” — retry; if it keeps failing, narrow the filters and tell your administrator.
• Fewer events in the file than expected — check the screen filters: the file is built exactly from them.
• Values in the file are masked — you do not hold the unblinded-data permission; this is expected.

Next

Verify the audit chain integrityRecompute the hash chain in the system before handing the file over.

Assemble the inspection packetThe trail together with anchors, access and design versions in one ZIP.

Audit trailWhat goes into the trail and how to read “before → after” entries.

Documents and certified copiesHow server-side documents work and how a recipient checks them.

More detail

Three formats

• XLSX — a register for people: the first sheet “About this export” (filters, cut, who built it and when, system), then the trail with before/after in words and the actor’s role and organization at the time of the action.
• PDF — the same picture as a printable PDF/A copy (landscape page, the table header repeats).
• CSV — a dynamic file for independent verification: human-readable columns plus every field of the hash-chain link, from which a record’s fingerprint can be recomputed without access to the system.

Trail levels

The same viewer opens at different levels; the level determines which records you see:

• Tenant — Admin → Audit trail: the whole organization’s trail (on-screen reading only);
• Study — Audit trail inside the study: its records only;
• Subject and form — the same viewer from the subject or form page.

Clicking a row expands the Before / After, Reason, Module and Caused by event details. If the filters match very many events, the server may cap the on-screen selection — the interface warns that what is shown is a lower bound; narrow the filters. More on reading the trail — Audit trail.

An export is an event too

Exporting the audit trail is a privileged read: the build itself and every download go into the audit trail. Who took the trail, when and with which filters is visible in the trail itself.