Creating and editing an amendment

Change an approved protocol the proper way: tracked changes, reasons, and review.

An approved protocol is locked — that is what makes its approval trustworthy. When the science or the practicalities change, you change the document the proper way: through an amendment. An amendment collects every edit, the reason for each one, and its own review and approval trail.

This guide covers creating an amendment, editing under it, and steering it through review to implementation. For past amendments and old versions, see Amendment history and versions.

Where to start#

You can open a new amendment from two places:

• From the protocol editor: open the approved protocol and click the Amendments button in the top bar. On the amendments page, click the blue Create Amendment button in the top-right corner.
• From the study page: on the protocol's card, click Amendments to unfold the list, then click New Amendment. (See Working with studies.)

Note: Only one amendment can be in progress at a time. If one is already underway, the New Amendment button is hidden — finish or withdraw the current one first.

Filling in the Create Amendment window#

A window titled Create Amendment opens. Work top to bottom:

1. Title (required) — a short name, for example "Amendment 1 - Updated Eligibility Criteria".
2. Type — choose one: Substantial (affects safety, scientific value, or conduct — needs IRB and regulatory review), Non-Substantial (Administrative) (typo-level or administrative changes), or Urgent Safety (immediate hazard — can be fast-tracked, see below).
3. Rationale (required) — why this amendment is necessary.
4. Change Summary — optional; a plain summary of the key changes.
5. Notice the blue information box: "Affected sections are detected automatically from your edits." You do not list sections here — Trelice records them as you edit.
6. Requires Re-consent — turn this switch on if participants must consent again. A Re-consent Rationale box then appears; explain why.
7. Click Create Amendment.

What you'll see: Trelice takes you straight into the amendment workspace — the protocol editor with an amber banner across the top.

Editing in the amendment workspace#

The amber banner reads Amendment #1 workspace followed by the amendment's title and the version numbers (for example "v1.0 → v2.0"). While this banner is showing, approved sections are unlocked for you.

1. Pick a section from the list on the left and edit it as usual.
2. When you open an approved section, an amber notice reminds you: "Saving reopens this approved section for re-review; each changed field needs a reason for change."
3. Click Save.

What you'll see: a panel headed Amendment changes on this section appears, listing each field you changed with its old and new value shown side by side. Each change carries a Reason for change box.

4. In each Reason for change box, write why the field changed — the hint reads "Why was this field changed? (required before submission)" — then click Save reason.

Changes without a reason show an amber Reason required badge, and the banner at the top counts them (for example "3 reasons needed"). Every reason must be filled in before the amendment can be submitted.

Note: Editing an approved section under an amendment returns that section to review. Reviewers will see exactly what changed, not the whole document — with a toggle between Changes only and Full section. The section review itself works as described in Sending a section for review.

Troubleshooting: If you open the protocol normally and everything is locked, look for the blue notice: "Amendment #1 is in progress. Sections are locked here — open the amendment workspace to edit them." Click Open workspace to get to the editable view.

The amendment page and its six tabs#

Click Amendment details in the banner (or open the amendment from the Amendments list) to reach the amendment's own page. Across the top are six tabs:

• Overview — a status timeline (Draft → Submitted for Review → Under IRB/Ethics Review → Under Regulatory Review → Approved → Implemented), plus the rationale, affected sections, and every key date. Alerts for rejection or re-consent appear here too.
• Section Changes — every changed field, grouped by section, with removed words shown struck out and added words highlighted. Schedule of Assessments changes appear as a table diff — added rows and ticks in green, removed ones in red. A Summary of Changes card lets you download the whole list: pick PDF or Word (DOCX), tick Include comments if you want the discussions, and click Download.
• Impact Assessment — switches for Safety Impact, Data Integrity Impact, Operational Impact, Statistical Impact, and Re-consent Required, each with a description box when turned on, plus Affected Countries and a Risk Assessment Summary. Click Save Impact Assessment when done.
• Approval Workflow — the internal review chain. Click Initialize Review to create the steps; the table shows each step's required role, reviewer, status, and comments. Below it, IRB / Ethics Review and Regulatory Review cards record external decisions: click Record IRB Decision (or Record Regulatory Decision), choose Approve or Reject, add the reference number and comments, and click Submit Decision.
• Sites & Countries — who must be told. Under Site Notifications, click Add Site to record a site, its country, and investigator; sites move from PENDING to NOTIFIED to ACKNOWLEDGED (an Acknowledge link appears for notified sites). Under Country Submissions, click Add Country and choose the submission type (Notification, Substantial Amendment, or Safety Report).
• History — a timeline of everything that happened to this amendment, with dates and names.

Moving the amendment forward#

The buttons at the top of the amendment page change with its status:

1. While in Draft, click Submit for Review. If it is grayed out, hover it — the tooltip says how many changed fields still need a reason.
2. Once submitted, click Submit to IRB when your ethics submission goes out. Record the IRB's decision on the Approval Workflow tab.
3. For a Substantial amendment, after IRB approval click Submit to Regulatory and later record that decision too.
4. When the amendment reaches Approved, click Implement. This freezes the new protocol version and makes it current.

For an Urgent Safety amendment still in Draft, a red Implement Safety (Fast-Track) button applies it immediately — regulations allow urgent safety measures first and paperwork after.

At any point before implementation you can click Withdraw; you will be asked for a reason, which goes into the record.

What you'll see after implementing: the status badge turns to Implemented, the protocol's version number increases, and the previous version is frozen and kept — see Amendment history and versions.