---
title: "ICF | Trelice"
description: "Trelice is an ICH M11-native platform for sponsors, CROs, and research sites to author clinical trial protocols and generate aligned downstream documents."
canonical_url: "https://www.trelice.com/products/icf"
---

Product / 02

# Informed consent, *automatically generated.*

Create master, country, site, and population-specific consent forms with the click of a button directly from the approved protocol. IRB-ready and auto-regenerating, with plain language held to a patient reading level.

[Book a demo](/contact) [See pricing](/pricing)

01 / Protocol-linked

## ICFs generated from the *structured protocol*, not re-typed.

Once Authoring signs off on a protocol, ICF pulls every relevant field (indication, procedures, risks, duration, compensation) into a consent skeleton. Update the protocol and every downstream ICF flags for regeneration.

-   Auto-generated from approved protocol fields
-   Change detection with per-section diff
-   Regenerate individual sites without rewriting from scratch

![Trelice master informed consent form editor: 16 consent sections listed at left, with the title page fields filled from the protocol](/images/app/11-consent-form-editor.png)

02 / Plain-language rewrites

## Medical terminology translated *without losing precision.*

Our plain-language engine rewrites protocol language for the target reading level you specify (default 8th grade). Reviewers can override any phrasing; overrides persist across regenerations.

-   Configurable reading level (6th-12th grade)
-   Multilingual: 12 languages shipping, more on request
-   Manual override system with per-site precedence

Plain-language rewrites (visual placeholder)

03 / Jurisdiction-aware formatting

## US, EU, UK, APAC, *each with the right boilerplate.*

Different jurisdictions require different sections, consent statements, and data-handling language. ICF maintains a catalog of jurisdictional requirements and applies them automatically.

-   HIPAA authorisation for US sites
-   GDPR-compliant data language for EU sites
-   Site-specific IRB/EC addenda

Jurisdiction-aware formatting (visual placeholder)

Workflow

## From approved protocol to IRB packet *in hours, not weeks.*

01

### Approved protocol lands

ICF detects the protocol approval event and queues a new ICF generation job.

02

### Site profile selected

Pick the site, jurisdiction, language, and reading level. ICF applies the right template.

03

### Plain-language draft

Review the draft side-by-side with the source protocol. Override phrasing where needed.

04

### IRB-ready export

Submission packet exports as Word + PDF with all boilerplate in place.

## See it on *your* protocol.

Bring a synopsis. We'll walk you through ICF in 30 minutes.

[Book a demo](/contact)