The master consent form

Create an informed consent form from your protocol and keep its reading level simple.

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 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.
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 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 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.
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.

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.

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.

What comes next#

Once the master consent form is approved, you can translate it and create country-specific versions. See Translations and country versions.