Reviewing and approving

The reviewer's side: reading a section, approving it, or asking the writer for changes.

When a colleague sends a protocol section for review, you — the reviewer — read it and give one of two answers: approve it, or ask for changes. This guide shows you where to find your reviews, how to decide, and what happens after you click.

How you find out it's your turn#

You are told in two ways:

• The bell at the top of the screen shows a notification — Section submitted for review when a writer submits a section you are assigned to, or Section ready for your review when an earlier review level finishes and yours begins. Being added as a reviewer also notifies you: Assigned as section reviewer.
• The section appears in your approval queue, which collects everything waiting on you.

You can also come across the section in Pending tasks or simply by opening it in the protocol editor — your reviewer buttons appear there too.

Reviewing from the approval queue#

1. Open My Approval Queue from the menu on the left.
2. Each waiting section is a white card: the section's name at the top, then its word count and when it was last updated, with a blue In Review badge on the right.
3. Below that, small colored dots show your fellow reviewers: green means approved, orange means changes requested, gray means pending.

What you'll see when nothing is waiting: a friendly card saying All caught up! with "No sections awaiting your review." underneath.

Note: The queue is handy for a quick decision, but for a careful read click View Section on the card to open the full section in the editor first. Read everything — your approval says you did.

Approving#

1. Read the section.
2. Click the blue Approve button.

That's it. Your decision is recorded with your name, the date and time, and it becomes part of the permanent record — see Electronic signatures and The audit trail.

The consistency acknowledgment#

Sometimes an amber Golden Thread Alert box sits above the buttons. It means a related section changed after this one was written — for example, the sample size was updated elsewhere — and the two might now disagree. Read more in Golden threads.

When this alert is present, Approve stays gray until you tick the checkbox that says I have verified cross-section consistency for this golden thread (in the editor the checkbox reads I've verified cross-section consistency). Ticking it is a real statement: you checked that the sections still agree. If they don't agree, do not tick it — request changes instead.

Troubleshooting: If Approve looks faded and does nothing, hover over it. The tooltip will say the golden thread acknowledgment box must be checked first.

Requesting changes#

1. Click Request Changes.
2. A text box opens. In the queue its hint reads "Describe what needs to change before approval…"; in the editor, "Describe what needs to change before this section can be approved…". Write clearly what the writer should fix — they will read exactly these words.
3. Click Send Feedback (or Cancel to back out).

What you'll see: the section leaves your queue. Its status becomes Changes Requested, the writer is notified, and your comments appear to them in an orange Reviewer feedback: box.

How multi-level review works, in plain words#

Your organization may use review workflows with levels — say, Level 1 is the Medical Writer and Biostatistician, Level 2 is the Medical Monitor.

• Level 1 reviews first. Only Level 1 reviewers can act; everyone else waits. Next to a waiting reviewer's name you'll see waiting for level 2.
• When every required reviewer of a level approves, the next level activates. Those reviewers get a Section ready for your review notification, and the purple badge on the section changes — for example from Review level 1 to Review level 2.
• A rejection at any level returns the section to the writer. The chain stops, the section becomes Changes Requested, and after the writer fixes it, review starts again from level 1.

If you try to decide before your level is active, Trelice politely refuses with a message like "Your review level (2) is not active yet — level 1 must finish first." Nothing is lost — just wait for your notification.

After the last level approves#

When the final required reviewer approves, the section's status becomes Approved, shown as a green badge and a green tick in the section list. The writer is notified (Section approved). The section is now locked: opening it shows "This section has been approved. Create an amendment to edit it."

Approved content can only change through a formal amendment — see Creating and editing an amendment. This lock is a feature, not an obstacle: it is what makes an approval mean something.

Note: Approving is not just a click — it is a recorded professional statement, kept forever in the audit trail with your name and timestamp. If you are not sure, request changes and say why. Nobody was ever criticized for reading too carefully.