Informed consent form authoring from the protocol, traced to source and written in plain words
A protocol amendment reaches every ethics committee in about a week, with each consent statement traced to its source and written in plain words.
See one case, screen by screen ↓An amendment lands and every consent form in the study family is out of date at once: the master, each country version, the site template, the pregnant partner form — sometimes a brand-new form for an optional sample. Each one has to say exactly what the new Schedule of Activities and the new IB edition say, and each one has an ethics date agreed with its committee.
The medical writer re-reads the protocol section by section, checks visit counts and frequencies by hand, rewrites sentences that came straight from the protocol into words a participant can follow, and checks the required elements for every regulation and country. Then the same changes are carried into a dozen forms, one at a time. A visit count left at the old number, or a word a participant cannot follow, comes back from the committee as a question — in the sample studies, the Spanish committee asked the CRV-118 team to explain “interstitial lung disease”.
Estimated split for one protocol amendment, by hand and with the solution — the typical and target days per step shown on the solution’s dashboard.
Seven agents read the protocol and risks, write, trace, simplify and check every form; a medical writer decides each change.
Protocol VLT-302 Amendment 3 arrives on 28 September with IB edition 7: liver tests at Weeks 2, 4 and 8, safety follow-up extended from 12 to 16 weeks, and a new optional genetic sample. Twelve consent forms need an update. Here is what happens next, screen by screen, in the working solution.
Lena opens the solution to a banner: “Protocol VLT-302 Amendment 3 arrived 28 Sep — 12 consent forms need an update.” Below it, the VLT-302 consent family — 14 countries, 112 sites, 12 forms — drawn from its sources to the master and out to every country, partner and genetic research form, each with its reading grade. Every country version is still on v3.2, waiting for the master. The US central IRB is due first, on Oct 21.
The protocol reader takes Amendment 3 — 112 pages, the Schedule of Activities and its 3 changes. The risk extractor reads IB edition 7: 14 reactions with frequencies and 1 new liver risk. The consent composer writes 15 sections from sponsor template v6.2, key information first, and the sections appear in the form as they are written.
“Draft ready — 10 rewrites proposed, 1 statement differs from the protocol, 2 required elements missing.”
Statement H4 reads “The study requires you to attend 12 visits at the study site over approximately 68 weeks.” The checker flags it against the cited passage: the amended Schedule of Activities has 13 visits, with Week 64 replaced by Weeks 60 and 68, and a maximum of 72 weeks. It proposes “You will come to the study clinic 13 times over up to 72 weeks” at grade 5.9. Lena can apply the correction, or keep the sentence with a reason — and then it goes to Dr. Maya Chen for a medical decision, and release waits for her.
A flagged statement blocks release until a person decides.
The new risk statement came out of the IB as “Veltrimab may cause elevations in hepatic transaminases, which in rare instances could be indicative of drug-induced hepatotoxicity.” The coach marks the hard words and proposes “Veltrimab may raise the level of some liver enzymes in your blood. In rare cases, this can be a sign of liver damage.” Beside it, IB edition 7 §6.4.2, p. 88, with the passage highlighted: ALT or AST above 3× ULN in 1.8% on Veltrimab vs 0.6% on placebo — which the form gives as about 2 in 100 and about 1 in 100.
The coach keeps every number and risk, and never changes locked regulatory wording.
Lena works through the coach’s list — “Prior to randomization, participants will undergo a screening period…” becomes “Before you start, a study doctor will check whether the study is right for you; this can take up to 4 weeks.” She accepts all 10; each one keeps its source citation and an undo. The form’s reading grade drops from 8.5 to 6.8, with no sentence left above grade 8.
The checker walks 21 CFR 50.25(a), (b) and (c), the key information section and EU CTR Article 29, listing the statements that satisfy each element. Two are missing, each with a drafted sentence and the reason: (b)(2), when the study doctor may stop participation (protocol §7.1), and the EU trial number every EU country version must state. Lena adds both.
Drafted: “The study doctor may take you out of the study if staying in could harm you or if you cannot follow the study plan.”
The Participant tab shows the key information page as a participant sees it — about 17 minutes to read the whole form. Lena has a 5-question comprehension quiz written for the consent interview: “Do you have to join this study?”, “How many study visits will you have?” Each answer points to the sentence it tests, and the quiz can go to Dana Okafor’s patient panel.
The release dialog shows reading grade 6.8 and 57 of 57 statements traced: “Every statement traced, every required element present, reading grade within target.” Lena signs as author with her password and the meaning “Author — I confirm this text matches its sources.” Dr. Maya Chen signs for medical accuracy and Omar Haddad for privacy and legal, and master v4.0 is released.
Amendment impact maps the three changes to every section of every form — key information, liver tests, 16-week follow-up, the new liver risk, the optional genetic research section, and the EU trial number for EU versions only. One button writes the tracked changes: Germany · German, 13 tracked changes, 4 country rules checked; the new genetic research form drafted from protocol §8.9. Every cell turns to updated, 11 of 11 forms written.
No silent edits: every change is tracked, and country text needs the country manager’s acceptance.
Sam sends the packages. Each country study manager signs their own version — Priya Raman for Germany, Claire Dumont for France, Kenji Mori for Japan — and each form goes to its committee with the traceability and readability reports.
The same amendment, seen by the five people who carry it — what their week looked like, and what it looks like now.
Seven agents read the protocol and risks, write, trace, simplify and check every form; a medical writer decides each change.
Reads the protocol and each amendment — synopsis, Schedule of Activities, design, procedures — and lists what changed.
Pulls risks from the Investigator’s Brochure with frequencies against placebo and turns percentages into “about N in 100 people”.
Writes the consent form section by section from the sponsor template and the extracted facts — key information first.
Checks every statement against the passage it cites and flags any number, visit, dose or duration that differs, with a corrected sentence.
Scores every sentence (Flesch-Kincaid, Gunning Fog) and proposes rewrites at or below the target grade that keep the meaning.
Checks 21 CFR 50.25, the key-information rule, EU CTR Art. 29 and each country’s rules — and drafts what is missing.
Carries master changes into every country, site and special form as tracked changes and prepares the text for certified translation and back-translation.
Accepts each change. The agents propose; a named person decides.
The writer, the reviewers and the country managers can ask about any consent form, statement, source or rule — or say what to change. Answers point to their sources.
What changed in the consent because of Amendment 3?
Amendment 3 changes 5 sections of the master and every country version: liver blood tests at Weeks 2, 4 and 8, then every visit; follow-up 12 → 16 weeks, 13 visits over up to 72 weeks; a new risk, liver enzymes up in about 2 in 100 people; a new optional genetic research section and form; and the visit count and main risks in key information. 12 forms are affected.
Which sentences are still above grade 8?
It lists each sentence in the VLT-302 master above the target with its grade and the grade of its rewrite, and filters the form to show only those.
Add the EU trial number to every EU country version
Done. “The EU trial number for this study is 2026-501234-17-00.” is in section 15 of the master and flows to the 5 EU country versions — Germany, France, Spain, Poland and Italy. The EU CTR Article 29 check is now complete. The change is on the audit trail for Lena Ortiz to confirm.
Write a 5-question comprehension quiz for the master
Five questions built from the key information page — “Do you have to join this study?”, “What is a placebo?”, “How many study visits will you have?”, “Which of these should you report right away?”, “If you say no to the genetic sample, what happens?” — each pointing to the sentence it tests.
13 screens from the working solution, on its sample data. Pick one to see it large.
Reading levels, who signs and the country rules are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Target reading grade for consent forms | Grade 8 | Grade 6 to 10 |
| Target for assent forms (ages 12–17) | Grade 5 | Grade 3 to 8 |
| Score with | Flesch-Kincaid | Flesch-Kincaid · Gunning Fog · Both |
| Never rewrite required wording | On | On · Off |
| Explain frequencies as “about N in 100 people” | On | On · Off |
| Medical accuracy signs | Dr. Maya Chen | Dr. Maya Chen · Omar Haddad |
| Patient panel review | Dana Okafor | Dana Okafor · Not required |
| Follow new protocol amendments automatically | On | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample study data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (published review of consent-form readability, 2005–2024 — 91% above grade 8). Regulations named — 21 CFR 50.25, EU CTR Art. 29 — are the rules the checker applies in the working solution. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that drafts the informed consent form from the protocol, the Investigator’s Brochure and the sponsor template, and keeps every master, country and site version in step. Consent Author adds agents that trace each statement to its source, score readability, check the required elements and write country versions as tracked changes.
Every statement links to the passage it came from. The traceability checker compares numbers, visit counts, doses, durations and frequencies with that passage and flags any difference with a corrected sentence. A flagged statement blocks release until a person decides.
It scores every sentence with Flesch-Kincaid and Gunning Fog, flags sentences above the target grade — 8 for consent forms and 5 for assent forms by default — and proposes plain-language rewrites that keep every number and risk. The writer accepts, edits or keeps each one.
Yes. The elements checker applies 21 CFR 50.25(a), (b) and (c), the key information section, EU CTR Article 29 for EU versions and each country’s rules from your approved library, shows the sentences that satisfy each element and drafts a sentence for any that is missing.
It maps each change to every section of every form. Once the new master is signed, the country adapter writes the change into each country, site and special form as tracked changes and checks that country’s rules; each country study manager accepts and signs their version before it goes to ethics.
Yes. The agents propose; the medical writer accepts each rewrite and decides each flag, and every released version is signed by the author, the medical monitor and privacy and legal. Required regulatory wording is locked and never rewritten.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your master ICF template, country rules, a protocol and its IB — and it goes live once every quality gate has passed. We will walk you through it on one of your own studies first.
A trial synopsis becomes a checked first-draft protocol in days, in your own approved language.
1-min filmTMF CheckEvery trial document is read, filed in the right place and checked, so the file is inspection-ready every day.
1-min filmCSR WriterResults sections and patient narratives are drafted within days of database lock, every number linked to its table.
1-min filmWe’ll run Consent Author on one of your protocols, its IB and your master template.