All guides · Review and approval

Sending a section for review

Assign reviewers, set due dates, submit a section, and what the statuses mean.

When a section of your protocol is written, it must be reviewed before it counts as approved. This guide walks you through the writer's side: choosing who reviews, setting dates, submitting, and what the statuses mean.

Everything described here lives in the panel below the writing area, at the bottom of the protocol editor. If you have not used the editor yet, start with The protocol editor at a glance.

The four statuses#

Every section is always in exactly one of these states. The colored badge at the bottom of the editor shows the current one.

Status What it means
Draft Being written. You can edit freely.
In Review Submitted. Editing is locked while reviewers read it.
Changes Requested A reviewer sent it back. You can edit again.
Approved Every reviewer approved. Locked — changing it later needs an amendment.

Assigning a writer#

Each section can have one responsible writer. Their name appears under the section's title in the list on the left, so everyone knows who owns it.

  1. Look below the writing area for the line starting with Assigned writer:.
  2. Click the dashed dropdown that says + Assign writer.
  3. Choose a colleague. Each name is followed by their role in brackets.

What you'll see: the writer's name appears as a small purple pill. Click the tiny x inside the pill to remove them.

Setting due dates#

Two dates keep the section on schedule:

  1. Next to Authoring due:, click the date box and pick the day the writing should be finished.
  2. Next to Review due:, pick the day the review should be finished.

What you'll see: the dates are saved as soon as you pick them. If a date passes, a red Overdue or Review overdue label appears under the section's name in the list on the left.

Choosing a review workflow#

A review workflow decides who reviews in what order — for example, "Level 1: Medical Writer, then Level 2: Medical Monitor." Your administrator builds these; see Setting up review workflows.

  1. Find the line starting with Review workflow:.
  2. Click the dropdown. It shows Tenant default plus every workflow your organization has created. The default one has (default) after its name.
  3. Pick one, or leave Tenant default to use your organization's standard.

What you'll see: a small gray line appears next to the dropdown, spelling out the levels — for example "L1: Medical Writer → L2: Medical Monitor". That is the exact path this section will travel.

Adding reviewers — role first, then person#

Reviewers are chosen in two steps: first the role, then the person.

  1. In the row with the small people icon, click Add reviewer (a dashed button).
  2. A dropdown appears saying Select role…. Pick the role you need. Roles the workflow still requires show (required) after their name — fill those first.
  3. A second dropdown appears saying Select reviewer…, listing only people who hold that role. Pick a person.

What you'll see: the person appears as a pill. Reviewers the workflow requires are marked required, and each shows a small purple level tag such as L1 or L2 once the section is submitted. Click the small minus on a pill to remove that reviewer. If no one is assigned yet, the row says No reviewers assigned.

Troubleshooting: If the second dropdown says No active users with this role, nobody in your organization holds that role yet. Ask your administrator to invite someone or adjust roles — see Roles and permissions.

"Every role of every level must be staffed"#

Before Trelice accepts a submission, it checks the chosen workflow level by level. Every role listed in every level must have at least one assigned reviewer who holds that role. One person per role is enough; extra reviewers outside the workflow are welcome but optional.

If a role is missing, submitting fails with a message like:

"Cannot submit for review: workflow 'Standard Review' has no assigned reviewer for level 2 (Medical Monitor). Assign the missing reviewers or change the workflow."

The fix is exactly what it says: add a reviewer with that role, or switch to a workflow whose roles you can cover.

Submitting#

  1. Make sure the section has saved content and at least one reviewer.
  2. Click Submit for Review at the bottom of the editor. While it works, the button reads Submitting….

What you'll see: the badge changes to In Review, and if a workflow applies, a purple badge appears saying Review level 1. A gray bar above the content says "Editing is locked while this section is under review." Level 1 reviewers get a notification; reviewers at later levels see waiting for level 2 (or 3, and so on) next to their name until their turn comes.

Troubleshooting: If you don't see the Submit for Review button, read the small message in its place — it tells you what is missing. "Save content first to enable review." means the section is still empty (for form-style sections it says "Fill in at least one field and save to enable review."). An orange "Assign a reviewer to enable submission." means no reviewer has been added yet.

Withdrawing from review#

Spotted a mistake after submitting? You can pull the section back.

  1. Open the section (it will show In Review).
  2. Click the orange Withdraw from Review button at the bottom.

What you'll see: the badge returns to Draft and editing unlocks. Any decisions reviewers had already made are cleared — when you resubmit, everyone starts fresh.

When changes are requested#

If a reviewer asks for changes, the badge turns orange: Changes Requested. An orange box labeled Reviewer feedback: shows what they wrote. Editing is unlocked — make the changes, click Save, and click Submit for Review again. The whole review starts over from level 1, which is deliberate: every reviewer confirms the corrected version.

For the other side of this process, see Reviewing and approving.