Creating informed consent forms for clinical trials is a meticulous, time-intensive process requiring precise regulatory language and comprehensive coverage of study risks, benefits, and subject rights. Manual drafting takes hours of careful review to ensure FDA and IRB compliance, with high stakes for errors that could delay trial approval or compromise participant protection.
Drafting Informed Consent Forms for clinical trials is a complex, time-intensive process requiring expertise in FDA regulations, ICH-GCP guidelines, and IRB requirements. Manual preparation takes 6-8 hours per document, with high risk of missing required elements under 21 CFR Part 50, leading to costly IRB rejections and trial delays.
CaseMark automates the creation of comprehensive, regulation-compliant Informed Consent Forms in minutes. Our AI ensures all required elements under 21 CFR Part 50.25, ICH-GCP E6(R2), and institutional standards are included, formatted for immediate IRB submission while maintaining participant accessibility.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys advising hospitals, research institutions, and medical practices need FDA-compliant informed consent forms for clinical trials and research studies involving human subjects.
Clinical trial consent forms are core healthcare law documents requiring compliance with HIPAA, patient rights regulations, and institutional review board requirements beyond just FDA regulations.
IP licensing attorneys working on pharmaceutical and biotech technology transfers need informed consent documentation when licensed technologies involve clinical trials or human subject research.
Technology licensing agreements for medical devices, pharmaceuticals, and biotechnology often include clinical trial obligations where proper informed consent documentation is essential for regulatory compliance and risk allocation.
Personal injury attorneys handling medical malpractice or clinical trial injury cases need to review and understand informed consent forms to assess whether proper disclosure and consent procedures were followed.
Defective or inadequate informed consent forms are frequently central evidence in litigation involving clinical trial injuries, experimental treatment complications, and research-related medical malpractice claims.
CaseMark's Informed Consent Form generator ensures full compliance with FDA regulations under 21 CFR Part 50 (including both basic and additional elements of informed consent), ICH-GCP E6(R2) guidelines, and HIPAA requirements. The output is structured to meet IRB submission standards and includes all required disclosures for participant protection.
The AI automatically generates content at an appropriate reading level (typically 8th grade or below) using plain language, active voice, and short sentences. Medical and technical terms are defined at first use, and the document structure uses clear headings and logical flow to maximize comprehension while maintaining regulatory compliance.
Yes, CaseMark allows full customization while maintaining regulatory compliance. You can incorporate sponsor-specific language, adjust for special populations (pediatrics, pregnant women, vulnerable subjects), add institution-specific contact information, and modify sections based on IRB feedback. The AI ensures required elements remain intact during customization.
You'll need your clinical trial protocol (including study objectives, procedures, and timeline) and the Investigator's Brochure (with risk and benefit information). Optional documents like sponsor templates, previous IRB feedback, or specific risk assessments help create a more tailored consent form. CaseMark extracts relevant information from these documents to populate all required sections automatically.
Manual ICF preparation typically requires 6-8 hours for an experienced regulatory professional to draft, review, and format all required sections. CaseMark reduces this to approximately 12-15 minutes for initial generation, plus your review time. This 97% time reduction allows faster IRB submission and accelerated trial startup timelines.