Reviewing Informed Consent Forms (ICFs) for Compliance and Ethical Considerations

Informed Consent is the cornerstone of ethical clinical research, ensuring that participants fully understand their rights, risks, and study procedures before enrolling in a trial. Regulatory agencies such as the FDA and TGA require strict adherence to Good Clinical Practice (GCP) guidelines to protect patient autonomy and data integrity.

This 2-hour interactive masterclass provides a step-by-step approach to reviewing Informed Consent Forms (ICFs) for compliance, ethical considerations, and regulatory approval. Participants will learn how to identify common deficiencies, apply best practices, and ensure alignment with international regulations to safeguard both patients and trial integrity.

Key Benefits of Attending

✔ Master ICF Compliance – Learn TGA, FDA and ICH-GCP requirements for Informed Consent.

✔ Ensure Ethical Integrity – Protect participant rights by ensuring clarity, transparency, and voluntariness in ICFs.

✔ Identify & Correct Common Deficiencies – Spot missing elements, ambiguous language, and regulatory gaps.

✔ Strengthen Regulatory Submission Success – Align ICFs with ethics committee and regulatory body expectations.

✔ Improve Stakeholder Communication – Ensure sponsors, CROs, and investigators maintain ICF consistency and compliance.

✔ Learn from Real-World Case Studies – Apply practical strategies from actual ICF review challenges.

What You’ll Learn:

✅ Key regulatory requirements for ICFs under ICH-GCP, FDA, and TGA

✅ Ethical principles of informed consent, including patient rights and autonomy

✅ Common compliance pitfalls and how to prevent regulatory findings

✅ How to assess readability and clarity to ensure participant understanding

✅ Best practices for ethics submissions and approval

✅ How to conduct an effective ICF review using real-world case studies

Who Should Attend?

🔹 Aspiring / Clinical Research Associates (CRAs)

🔹 Clinical Trial Coordinators (CTCs)
🔹 Clinical Investigators & Site Staff
🔹 Regulatory Affairs & Quality Assurance Professionals
🔹 Ethics Committee Members & IRB/IEC Representatives
🔹 Sponsors & CRO Teams
🔹 Anyone involved in clinical trial compliance & patient consent processes

🔹 University Graduates & Career Changers in Clinical Research
🔹 Anyone looking to strengthen their industry skills

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!