| name | informed-consent-form-clinical-trial |
| title | Informed Consent Form — Clinical Trial |
| description | Drafts an IRB-ready Informed Consent Form (ICF) for FDA-regulated clinical trials compliant with 21 CFR 50.25, 50.27, and ICH-GCP. Use when drafting or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/informed-consent-form-clinical-trial |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
| tags | ["agreement","drafting","regulatory"] |
Informed Consent Form — Clinical Trial
Produces a plain-language ICF (≤ 8th-grade reading level) covering all 21 CFR 50.25 required elements, HIPAA authorization, and ethics-compliant framing for research subjects.
Prerequisites
Collect before drafting:
- Protocol details — title, protocol number, phase, sponsor, IND number
- Investigational product — name, mechanism, dosing, route, known risk profile
- Study design — randomization, arms (incl. placebo), visit schedule, duration
- Site info — PI name/title, institution, IRB name and contact
- Risk/benefit data — preclinical and prior clinical risk frequencies/severities
- Injury/compensation policy — sponsor coverage for research-related injury; participation payments
Output Structure
1. Header Block
On every page: protocol title, protocol number, version/date, page X of Y.
2. Study Information
Purpose
- Plain-language disease/condition description
- What the study tests; trial phase; subject count (site and total)
- Include: "This is a research study, not standard medical treatment."
Procedures (chronological)
- Screening, randomization (arm probabilities incl. placebo), visit-by-visit table:
| Visit | Timing | Duration | Procedures |
|---|
| Screening | Week −2 | ~2 hrs | Labs, exam, eligibility |
| Baseline | Day 1 | ~3 hrs | IP administration, vitals, ECG |
| Follow-up | Wk 4, 8, 12 | ~1 hr | Labs, safety assessments |
| End of Study | Week 16 | ~2 hrs | Final assessments, unblinding |
- Flag research-only vs. standard-of-care procedures
- Note preparation requirements (fasting, hold meds)
Risks and Discomforts
Organize by category with frequency and severity:
| Category | Example | Frequency | Severity |
|---|
