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Informed consent, in the patient’s language.

Generate site-, jurisdiction-, and population-specific informed consent forms directly from an approved protocol. Plain-language rewrites, IRB-ready formatting, automatic regeneration when the protocol changes.

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
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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
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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 catalogue of jurisdictional requirements and applies them automatically.

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