Amendment history and versions

Every past version of your protocol, what changed in each, and how to download old ones.

A clinical trial can run for years, and its protocol rarely stays untouched. Trelice keeps every past version of your protocol, exactly as it was approved, forever. This guide shows you what a version is, where to find old ones, how to see what each amendment changed, and how to download any version as a PDF or Word file.

What a version is#

A version is a complete, frozen copy of the protocol, captured automatically at the moment of approval:

• Version 1.0 is frozen when the original protocol is approved.
• Each implemented amendment freezes the next version (2.0, 3.0, and so on).

Frozen means frozen. Nothing edits a captured version — not amendments, not administrators. When a reviewer approved version 1.0, they approved exactly what you can still download today. This is the backbone of the permanent record, alongside the audit trail.

Finding a protocol's versions#

Versions live on the study page, on the protocol's card.

1. Open your study from the Studies list (see Working with studies).
2. Find the protocol's card. Near the bottom, once a protocol has been approved, you'll see two small fold-out rows: Amendments and Versions.
3. Click Versions. The arrow turns downward and the list unfolds.

What you'll see: one row per frozen version — for example Version 1.0 — with when it was approved and by whom underneath. If nothing is listed yet, the text explains why: "No frozen versions yet. A version is captured each time the protocol or an amendment is approved."

Downloading an old version#

Each version row carries two small buttons on the right:

1. Click PDF to download that exact frozen version as a PDF, or Word for a Word document.
2. The button briefly shows progress while the file is prepared, then your browser downloads it. If you lose track of the file, see Downloading PDF and Word documents.

Note: The original version stays downloadable after amendments supersede it. If an inspector asks "what did version 1.0 say?", the answer is two clicks away.

Seeing what changed in each amendment#

The version numbers tell you that the protocol changed; the amendments tell you what and why.

1. On the protocol's card, click Amendments to unfold the list. Each row shows the amendment's number, title, version movement (for example "v1.0 → v2.0"), how many sections were affected, and a status badge such as Implemented. A draft row invites you with Continue working →.
2. Click an amendment to open its page.
3. Open the Section Changes tab to see every changed field with its old and new value side by side, plus the written reason for each change. From here you can also download the Summary of Changes as PDF or Word.
4. Open the History tab for the amendment's own timeline — created, submitted, IRB decision, approval, implementation, each with date and name.

The full workflow behind these tabs is described in Creating and editing an amendment.

The amendment history table#

Trelice also keeps a single table of every amendment a protocol has ever had, titled Amendment History (its subtitle notes it follows ICH E3 amendment tracking). It shows one row per amendment with these columns: #, Title, Type, Status, Version, Approved, Approved By, Affected Sections, and Summary.

• Click any column heading to sort the table by it. Click again to reverse the order.
• Click Export CSV in the top-right corner to download the whole table as a spreadsheet file — useful for submission cover letters or a quick management summary.

If the protocol has never been amended, the table simply says No amendments yet.

Note: This table lives at its own web address, ending in "amendment-history", rather than behind a button in the app's menus. Day to day you will not miss it — the Amendments fold-out on the study page and each amendment's own tabs show the same information. Reach for the table when you want everything in one sortable list or need the CSV export.

Which version am I looking at right now?#

• In the protocol editor, the current version number appears under the protocol's title in the left-hand panel (for example "v2.0").
• While an amendment is in progress, the amber workspace banner shows both numbers — "v2.0 → v3.0" — so you always know what the working copy will become.

Troubleshooting: If the Versions row is missing from a protocol's card, the protocol has not been approved yet — the fold-outs only appear once a protocol reaches approved status. A protocol still in Draft or In Review has no frozen versions, because versions are only captured at approval.