The audit trail

The permanent record of who did what and when — how to read, filter, and search it.

The audit trail is Trelice's permanent diary. Every meaningful action — creating a study, editing a section, approving, signing, exporting, even signing in and out — is written down automatically, with who did it and exactly when. Nothing in this diary can ever be changed or erased, by anyone.

Who can see it#

The Audit Trail page appears in the left menu only for certain roles: System Administrators, Sponsor Administrators, Regulatory Affairs users, and platform administrators. If you do not see it, your role simply does not include audit access — see Roles and permissions.

You only see your own organization's activity. Other organizations' records are never shown.

Note: You do not need this page to see the history of one specific protocol. Every protocol has its own audit report, open to its team — see Progress and audit reports.

Reading the page#

Open Audit Trail from the left menu. At the top is a shield icon, the heading Audit Trail, and the line "21 CFR Part 11 §11.10(e) — immutable activity log".

Below is a table of the 50 most recent events, newest first. The page quietly refreshes itself every 30 seconds, so new activity appears without you doing anything.

The columns are:

• Timestamp — the exact date and time, to the second (for example, 2026-08-03 14:22:05).
• Action — a colored badge naming what happened: CREATE, UPDATE, DELETE, VIEW, SIGN, APPROVE, REJECT, SUBMIT, EXPORT, LOGIN, or LOGOUT. Approvals are green, rejections and deletions red, signatures purple, and so on.
• Entity — the kind of thing acted on (a Protocol, a section, a user…), with a short reference code.
• Description — a plain-language sentence about the event.
• User — the email address of the person who did it. "system" means Trelice itself did it automatically.

Click any column heading to sort by it; click again to reverse the order. For example, click User to group one person's activity together, or Action to gather all approvals.

Seeing exactly what changed#

Some entries — content edits especially — carry the full before-and-after.

1. Find the entry in the Description column.
2. If it has one, click the small blue Show change link beneath the description.
3. A gray panel unfolds with two columns: the old text on the left, the new text on the right. Removed words are highlighted in red; added words in green.
4. Beneath the text, small notes may show the word count and which revision number the old version was saved as.
5. Click Hide change to fold the panel away.

What you'll see: the exact wording difference between two saves, at a glance — no need to open the document and compare by eye.

Why the audit trail can never be edited#

Clinical trial records in the United States fall under a regulation called 21 CFR Part 11, which requires a secure, computer-generated, time-stamped record of who did what — one that no one, not even an administrator, can alter afterward. Trelice's audit trail is built to be append-only: entries can only ever be added, never modified or deleted. That is not a limitation to work around; it is the guarantee that makes the record trustworthy to inspectors, sponsors, and your future self.

This is also why you may occasionally see an entry for something you did by mistake and immediately undid. Both the mistake and the correction are recorded. That is normal and expected — a complete record includes the corrections.

Practical uses#

• "Who changed this?" — Sort by Timestamp, look for UPDATE entries on the entity in question, and open Show change to see the wording.
• Preparing for an inspection — For a single protocol, use its dedicated audit report instead, which can be filtered by action, entity, and person: see Progress and audit reports.
• Checking sign-ins — LOGIN and LOGOUT entries show when each account was used. Unusual times or unfamiliar addresses are worth raising with your administrator — see Managing users and invitations.

Troubleshooting: If the page shows No audit entries yet., your organization is new and no activity has been recorded — the first entries will appear as soon as people start working. If you expected to find an older event and it is not in the table, remember this page shows only the 50 most recent entries; use the protocol's own audit report for a complete, filterable history of that protocol.

Every approval decision, electronic signature, and export you will read about elsewhere in these guides ends up here. You never have to do anything to keep the audit trail up to date — being automatic is the whole point.