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Informed Consent Form Clinical Trial

Draft IRB-Ready Consent Forms in Minutes, Not Hours

12 minutes with CaseMark

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Informed Consent Form Clinical Trial

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Workflow

Informed Consent Form Clinical Trial

Overview

CaseMark's Informed Consent Form generator uses AI to draft comprehensive, IRB-ready consent documents for FDA-regulated clinical trials. It automatically structures all required regulatory elements under 21 CFR 50.25 and ICH-GCP guidelines into a plain-language document that research subjects can readily understand. From study purpose and visit schedules to risk tables and HIPAA authorization, every section is generated from your uploaded protocol and investigator brochure.

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 accessible to lay participants. Manual drafting often takes days, involves multiple revision cycles, and risks omitting critical regulatory elements that delay IRB approval.

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 tables, plain-language explanations, and all required sections—ready for your team's review and IRB submission in a fraction of the traditional time.

How it works

  1. 1. Upload your clinical trial protocol and investigator brochure

  2. 2. AI extracts study design, procedures, risks, and site details

  3. 3. CaseMark drafts a complete IRB-ready ICF with all required regulatory elements

  4. 4. Review, customize, and export in your preferred format (DOCX, PDF)

What you get

  • Header Block with Protocol Identification

  • Study Information and Purpose Statement

  • Procedures Table with Visit Schedule

  • Risks and Discomforts by Category and Frequency

  • Benefits, Alternatives, and Compensation Sections

  • HIPAA Authorization and Privacy Protections

  • Voluntary Participation and Withdrawal Rights

  • Signature and Contact Information 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 formatted header blocks with protocol title, version, and pagination

Required documents

  • Clinical Trial Protocol

    The full study protocol including trial design, objectives, visit schedule, endpoints, and investigational product details

    .pdf, .docx

  • Investigator Brochure

    The investigator brochure or equivalent document containing the investigational product's known risk profile, preclinical data, and prior clinical safety information

    .pdf, .docx

Supporting documents

  • Sponsor ICF Template

    Sponsor-provided ICF template or institutional IRB consent form template for formatting alignment

    .pdf, .docx

  • Previous ICF Version

    A prior version of the informed consent form if revising an existing document

    .pdf, .docx

  • Compensation and Injury Policy

    Sponsor policy documents covering research-related injury compensation and participant payment schedules

    .pdf, .docx

Why teams use it

Reduce ICF drafting time from days to minutes while maintaining full regulatory compliance

Ensure consistent inclusion of all 21 CFR 50.25 required and additional consent elements

Produce plain-language documents at ≤ 8th-grade reading level to improve subject comprehension

Generate structured risk tables and visit schedules that streamline IRB review and approval

Questions

Does the generated ICF comply with FDA regulations?

Yes. CaseMark structures every ICF to include all required elements under 21 CFR 50.25(a) and additional elements under 50.25(b), as well as ICH-GCP guidelines. You should still have your IRB and regulatory team review the final document before submission.

What reading level does the consent form target?

CaseMark generates ICFs written 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 risk-benefit framing and procedural detail based on the trial phase and study design you provide.

Does the ICF include HIPAA authorization language?

Yes. CaseMark automatically includes a HIPAA authorization section covering the use and disclosure of protected health information for research purposes, aligned with 45 CFR 164.508 requirements.

How long does it take to generate a complete ICF?

CaseMark typically generates a comprehensive, multi-section ICF in approximately 10-12 minutes. This replaces what traditionally takes hours or even days of manual drafting and formatting.

Can I customize the output for my institution's IRB template?

Yes. After CaseMark generates the ICF, you can review and edit every section before exporting. Many users adapt the output to match their institution's specific IRB template requirements and branding.

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