Informed Consent Form Clinical Trial

Draft IRB-Ready Consent Forms in Minutes, Not Hours

12 minutes with CaseMark

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12 minutes with CaseMark

What you'll need

Clinical Trial Protocol
Investigator Brochure

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's Informed Consent Form skill uses AI to draft comprehensive, IRB-ready consent documents for FDA-regulated clinical trials. It automatically structures all required elements under 21 CFR 50.25, ICH-GCP, and HIPAA into a plain-language document that research subjects can clearly understand. From protocol extraction to risk tables and signature blocks, the entire ICF is generated in minutes.

Drafting Informed Consent Forms for clinical trials is one of the most time-consuming regulatory tasks in clinical research. Each ICF must address dozens of required elements across FDA regulations, ICH-GCP guidelines, and HIPAA requirements—all written in plain language that research subjects can understand. Manual drafting often takes days, involves multiple revision cycles, and risks omitting critical regulatory elements.

CaseMark automates the heavy lifting of ICF creation by extracting study design, risk profiles, and procedural details directly from your protocol and investigator brochure. The AI assembles a complete, regulation-compliant consent document with structured visit tables, categorized risk disclosures, HIPAA authorization, and signature blocks—all at a plain-language reading level ready for IRB review.

How it works

1. Upload your clinical trial protocol and investigator brochure
2. AI extracts study design, risk data, procedures, and site details
3. CaseMark drafts a complete IRB-ready ICF with all required regulatory elements
4. Review, customize, and export the finished consent form (DOCX, PDF)

What you get

Header Block with Protocol Identification
Study Information and Purpose Statement
Chronological Procedures and Visit Schedule Table
Risks and Discomforts Organized by Category and Severity
Benefits, Alternatives, and Compensation Details
HIPAA Authorization and Confidentiality Provisions
Voluntary Participation and Withdrawal Rights
Signature and Consent Blocks

What it handles

Generates plain-language ICFs at ≤ 8th-grade reading level for research subjects
Covers all 21 CFR 50.25 required and additional elements automatically
Produces structured visit-by-visit procedure tables with timing and duration
Organizes risks and discomforts by category, frequency, and severity
Includes HIPAA authorization language and ethics-compliant framing
Outputs header blocks with protocol title, version, date, and page numbering

Required documents

Clinical Trial Protocol
The full study protocol including design, objectives, procedures, visit schedule, and eligibility criteria
.pdf, .docx
Investigator Brochure
Product safety and efficacy data including known risks, adverse events, preclinical and clinical findings
.pdf, .docx

Supporting documents

IRB Template or Institutional Guidelines
Site-specific IRB consent form template or formatting requirements
.pdf, .docx
Sponsor Consent Template
Sponsor-provided model consent language or required boilerplate provisions
.pdf, .docx
Injury and Compensation Policy
Sponsor or institutional policy on research-related injury coverage and participant compensation
.pdf, .docx

Why teams use it

Reduce ICF drafting time from hours or days to approximately 12 minutes

Ensure regulatory compliance with 21 CFR 50.25, 50.27, and ICH-GCP automatically

Produce plain-language documents at ≤ 8th-grade reading level for better subject comprehension

Standardize consent form quality across multiple trial sites and protocols

Questions

Does the generated ICF comply with FDA regulations?

Yes. CaseMark structures the Informed Consent Form to address all required elements under 21 CFR 50.25 and 50.27, as well as ICH-GCP guidelines. You should still have your IRB and regulatory team perform a final review before submission.

What reading level is the consent form written at?

CaseMark generates ICFs at or below an 8th-grade reading level, using plain language throughout. This meets FDA guidance and IRB expectations for ensuring research subjects can meaningfully understand the consent document.

Can I use this for different trial phases?

Absolutely. CaseMark supports ICF drafting for Phase I through Phase IV trials, IND studies, and other FDA-regulated protocols. The AI adapts the content structure based on the study design and risk profile you provide.

Does the output include HIPAA authorization language?

Yes. CaseMark automatically includes HIPAA authorization provisions covering the use and disclosure of protected health information for research purposes, integrated directly into the consent form as required by most IRBs.

How long does it take to generate a complete ICF?

CaseMark typically produces a comprehensive draft Informed Consent Form in approximately 10–12 minutes, compared to the hours or days it can take to draft one manually from scratch.

Can I customize the output after generation?

Yes. CaseMark provides a fully editable document that you can tailor to your institution's specific IRB templates, sponsor requirements, and site-specific details before final submission.