---
title: "The master consent form | Trelice User Guide"
description: "Create an informed consent form from your protocol and keep its reading level simple."
canonical_url: "https://www.trelice.com/docs/master-consent-form"
---

# The master consent form

An informed consent form (ICF) explains a study to a participant in plain words, so they can decide whether to join. In Trelice, you do not start a consent form from a blank page. The system builds one from your [protocol](/docs/glossary) and fills in everything it already knows. You review, simplify, and send each section for approval, the same way you work on the protocol itself.

> **Note:** Consent forms are part of the **ICF Master** product. If your organization's contract does not include it, the consent form screens are not available, and trying to open one shows a "not permitted" message. Your administrator can confirm which products your organization has.

## Creating a consent form

1. Open your protocol in the editor. See [The protocol editor at a glance](/docs/protocol-editor-overview).
2. Click the **Documents** button in the row of buttons at the top-right of the editor.
3. What you'll see: a page titled **Document Generation** with a grid of cards.
4. Click the card named **Consent Forms**.
5. What you'll see: a small window titled **Consent Forms (ICF)**. Any consent forms that already exist are listed at the top. Below them, under **Create new consent form:**, is one button for each region you have not created yet.
6. Click the region you need:
   - **USA**: United States (FDA 21 CFR Part 50)
   - **EU**: European Union (EU CTR 536/2014 + GDPR)
   - **GLOBAL**: Global (all regulatory requirements)
7. What you'll see: the button briefly says **Creating…**, then the consent form editor opens with the new form.

> **Note:** You can have one consent form per region. If all three exist, the window says **All regions covered.**, open the one you need from the list instead.

## The 16 sections

The left-hand panel lists the sections of the consent form, from the title page down to the signature block. There are 16 in total, covering everything regulators expect: a title page, a key information summary, an introduction, study procedures, duration, risks and discomforts, benefits, alternatives, confidentiality, data protection (GDPR), compensation and costs, insurance, contact information, voluntary participation, optional studies, and the signature block.

Each section is a short form with labeled boxes, not a blank page, the same idea as [structured sections](/docs/structured-sections) in the protocol. A blue banner at the top of each section explains what belongs in it. Sections marked **Required section** must have content before the form is complete; the **Required sections** counter and green progress bar at the top-left show how many are done.

Beside each section name in the list, a small icon shows its state: a green circle with a check for approved, a blue eye for in review, an orange circle for changes requested, and a small dot when the section is still empty.

## Trelice fills in what it can

When the form is created, Trelice copies matching information from the protocol into the sections, the study title, the procedures, the visit schedule, the risks, and more. Sections drafted by the system carry a small purple **AI** tag in the section list.

If you want a fresh draft of a section, click **Regenerate with AI** at the bottom of the editor. Your current content is saved as a revision first, so nothing is lost.

## The reading level badge

Consent forms must be easy to read. Trelice measures each drafted section with the Flesch-Kincaid scale and shows a small badge at the bottom of the editor:

- Green, for example **Grade 2.8 · 8-yr-old ready**. The target is met.
- Amber, for example **Grade 4.5 · needs simplification**. Close, but simplify.
- Red, the badge says **Reading level too high**.

The target is a grade level of 3.0 or below, the reading level of an 8-year-old. When a drafted section is above the limit, the **Submit for Review** button is replaced by a red message:

**Reading level too high, rewrite or regenerate before submitting.**

Shorten the sentences, swap medical words for everyday ones, or click **Regenerate with AI** for a simpler draft. The badge updates after the next save.

## Sending a section for review

Review works exactly as it does for protocol sections, see [Sending a section for review](/docs/submitting-for-review) for the full picture.

1. At the bottom of the section, next to **Review workflow:**, leave **Tenant default** or pick a named workflow. See [Setting up review workflows](/docs/review-workflows-and-approvals-setup).
2. Click **Add reviewer** and choose a colleague from the list. People whose role matches a required reviewer role appear first, under **Matches required role**.
3. Click **Submit for Review**.
4. What you'll see: the section's badge changes to **In Review** and a gray bar says "Editing is locked while this section is under review."

> **Troubleshooting:** If there is no **Submit for Review** button, look for the orange message **Assign a reviewer to enable submission.**, a section needs content and at least one reviewer before it can be submitted.

Reviewers see **Approve** and **Request Changes** buttons when it is their turn. If changes are requested, the reviewer's comments appear in an orange box under **Reviewer feedback:** and you can edit again. See [Reviewing and approving](/docs/reviewing-and-approving).

## The PDF preview panel

You can see the finished document while you type.

1. Click the **Preview** button at the top-right of the editor.
2. What you'll see: the screen splits in two. Your section is on the left; a live PDF of the consent form is on the right, updating as you edit.
3. Click **Hide Preview** to return to the full-width editor.

When you are ready to download the document, use the **PDF**, **Word**, or **Redacted PDF** buttons in the same row. See [Downloading PDF and Word documents](/docs/exporting-documents).

## Saving and working together

Your work saves automatically every few moments; the small status text at the bottom shows when it last saved, and a **Save** button is there if you prefer to save by hand. If a colleague has the same section open, a blue banner names them. You can also discuss any field with [comments](/docs/comments-and-collaboration).

## What comes next

Once the master consent form is approved, you can translate it and create country-specific versions. See [Translations and country versions](/docs/translations-and-country-consent-forms).