Electronic signatures

Signing a protocol electronically and why the system asks for your password again.

Clinical documents have always been signed. On paper, a signature ties three things together: who agreed, what they agreed to, and when. In Trelice the same three things are captured electronically, automatically, every time you approve something. This guide explains what that record is, where to see it, and why your account and password matter so much.

What "signing" means in Trelice#

In Trelice there is no separate signing ceremony with a pen-shaped button. Your recorded approval decision is the signed act. When you click Approve on a section (see Reviewing and approving), the system permanently records:

• Who — your full name and account, exactly as you signed in.
• What — the specific section, in the exact state you reviewed.
• When — the date and time, to the second.
• Why — the meaning of the act: that you reviewed the content and approve it. If you requested changes instead, your written comments are stored with the decision.

This is why the buttons are worded the way they are. Clicking Approve is the electronic equivalent of initialing a page: a professional statement in your name, made knowingly. If a golden thread alert is showing, you also tick an explicit acknowledgment — I have verified cross-section consistency for this golden thread — before the system lets you approve. That tick is stored too. See Golden threads.

Where the record lives#

You can see the evidence of every approval in three places:

1. On the section itself. Open the section in the protocol editor. Below the content, each reviewer is listed with a colored dot and a word: green with approved, orange with changes requested, gray with pending.
2. In the audit trail. Every submission, approval, rejection (with its comments), and withdrawal is written to the permanent, unchangeable audit trail. Entries are never edited or deleted — not by you, not by an administrator. From the protocol editor you can also click the Audit Report button in the top bar to see a printable record for that protocol — see Progress and audit reports.
3. In frozen versions. Each time a protocol or an amendment is approved, Trelice freezes a complete copy of the document as it stood at that moment. The approval is therefore tied to exact, unchangeable content, and you can download it years later — see Amendment history and versions.

What you'll see: in the audit trail, an approval reads like a sentence — the section name, the decision, the reviewer's name, and any comments in quotation marks — with the date and time beside it.

Your account is your signature#

Because the record says you did it, it matters that only you can act as you.

• Never share your password, and never approve anything from a colleague's screen while they are signed in. The record would carry the wrong name — and there is no way to quietly fix a permanent record.
• Trelice signs you out after about an hour of inactivity. This can feel strict, but it exists for the same reason: an unattended, signed-in screen is an invitation for actions in your name. A warning appears shortly before you are signed out so you can stay working. See Signing in and your account.
• If you believe someone else has used your account, tell your administrator immediately and change your password.

Note: These habits are not just politeness. Regulators treat electronic approval records as equivalent to handwritten signatures, which is exactly why the system is built so each one is attributable to a single, verified person.

Approvals cannot be quietly undone#

Once a section is Approved, it locks. Nobody — including the approver — can edit it in place. Changing approved content requires a formal amendment, where every changed field carries a written reason and goes through review again. The original approval, and the version it applied to, remain on record untouched.

If a reviewer approves and then realizes something is wrong, the honest path is the same one paper uses: raise it, and correct it through an amendment. The trail then shows both the original decision and the correction — which is exactly what a trustworthy record looks like.

Common questions#

Does clicking Approve really carry weight? Yes. Treat it like signing your name. Read the whole section first, and if you are unsure, use Request Changes and explain why.

Can an approval be removed from the record? No. Later events (an amendment, a re-review) are added to the record; nothing already recorded is altered.

What if I approved the wrong section by mistake? Contact the section's writer or your administrator. The practical remedy is a new review cycle or an amendment; the mistaken click stays visible in the trail, followed by its correction.

Troubleshooting: If you were expecting a separate "sign here" screen and cannot find one, you are not missing anything — approvals in Trelice are recorded through the review buttons described above, and the proof lives in the audit trail.