H1ST-AI-DBD-001 · Task 1.2
The one document you can't get wrong
When consent is high-stakes and every version multiplies the risk, the drafting shouldn't rest on manual effort. The Informed Consent Agent produces complete, compliant ICFs from the protocol — all required elements per ICH-GCP and 21 CFR Part 50, written in plain language at an 8th-grade reading level, with master and site-specific versions — so participants understand what they're agreeing to and you can stand behind every page.
The grind you know
Consent is the document you can't get wrong. Every required element has to be there, it has to read plainly enough for a participant to truly understand, and it has to bend to each country, IRB, and Ethics Committee. Drafting and maintaining all those versions by hand is slow, and every manual edit is one more place an error can hide — in the document where errors matter most.
Part of the Database & Forms Design family
Protocol to CRF, ICF, SDTM & coding.
When consent is high-stakes and every version multiplies the risk, the drafting shouldn't rest on manual effort. The Informed Consent Agent produces complete, compliant ICFs from the protocol — all required elements per ICH-GCP and 21 CFR Part 50, written in plain language at an 8th-grade reading level, with master and site-specific versions — so participants understand what they're agreeing to and you can stand behind every page.
The agent pulls purpose, procedures, risks, benefits, and alternatives from the protocol.
All required elements are drafted at an 8th-grade reading level, adapted to study type.
Master and site-specific versions are produced with redlines and IRB/EC submission packages.
Capabilities
Generates all 23 required elements per ICH-GCP, adapting content to study type — interventional, observational, pediatric, or emergency.
Applies Flesch-Kincaid readability scoring to keep consent at an 8th-grade reading level for participant understanding.
Manages a master ICF plus site- and country-specific versions, including addenda such as the EU Data Protection Officer contact.
Tracks changes with redline generation and assembles IRB/EC submission packages with cover letters and supporting documents.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
You are adding a European site and need the consent adapted for local requirements, including the EU Data Protection Officer contact. The agent spins a site- and country-specific version off the master ICF with redlines, so you are not hand-editing a fresh document under time pressure.
An IRB has pushed back before because consent read like a legal brief a participant couldn't follow. The agent applies Flesch-Kincaid scoring to keep the ICF at an 8th-grade reading level while still carrying all 23 required ICH-GCP elements.
Submission day means collating the ICF, cover letter, and supporting documents into one package for the board. The agent assembles the IRB or Ethics Committee submission package for you, so nothing required is missing when it goes out.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Gemini / Anthropic LLM
LLM
Paddle OCR
OCR
Who it's for
Translates informed consent into 30+ languages with back-translation verification.
Learn moreDigitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
Learn moreEdit CRFs, validations, and ICFs with natural-language instructions — like ChatGPT for study build.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
