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.
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
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
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
From approved protocol to IRB packet in hours, not weeks.
Approved protocol lands
ICF detects the protocol approval event and queues a new ICF generation job.
Site profile selected
Pick the site, jurisdiction, language, and reading level. ICF applies the right template.
Plain-language draft
Review the draft side-by-side with the source protocol. Override phrasing where needed.
IRB-ready export
Submission packet exports as Word + PDF with all boilerplate in place.