Masterclass: Mastering Clinical Trial Documentation Maintenance: Best Practices for Trial Master File (TMF) Compliance & Inspection Readiness

Proper management of the Trial Master File (TMF) is essential for ensuring regulatory compliance, maintaining data integrity, and supporting the success of clinical trials. A well-maintained TMF not only facilitates smoother audits and inspections but also demonstrates the trial's adherence to Good Clinical Practice (GCP) and regulatory requirements.

Are you an aspiring or early-career clinical research professional looking to strengthen your TMF filing and maintenance skills? Managing essential trial documentation effectively is a critical skill for Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Study Coordinators, and other research professionals.

This interactive 2-hour masterclass will provide you with practical strategies to improve your TMF documentation processes and ensure your files are always audit- and inspection-ready. Learn how to maintain document integrity, apply best practices for version control, conduct quality control (QC) checks, and meet regulatory expectations to prevent findings during audits.

Key Benefits:

🔹 Ensure Compliance & Inspection Readiness – Learn how to maintain a complete and accurate TMF to meet regulatory and sponsor requirements.
🔹 Reduce Audit Risks – Identify common TMF deficiencies and implement corrective actions to improve documentation quality.
🔹 Enhance Your Career Prospects – Gain expertise in TMF management, a crucial skill valued by sponsors, CROs, and regulatory agencies.
🔹 Hands-on Learning with Industry Experts – Access real-world case studies and actionable insights from experienced professionals.

What You’ll Learn:

✅ Understanding TMF Structure & Regulatory Expectations – Learn about essential documents and global regulatory requirements (ICH-GCP, EMA, FDA).
✅ Best Practices for TMF Filing & Maintenance – Organise, categorise, and maintain TMF documentation efficiently.
✅ Document Version Control & QC Checks – Implement processes to track changes, prevent errors, and maintain data integrity.
✅ Strategies for Ensuring Inspection Readiness – Proactively identify and resolve TMF gaps before audits and inspections.

Who Should Attend?

🔹 Aspiring Clinical Research Associates (CRAs)
🔹 Clinical Trial Assistants (CTAs)
🔹 Research Nurses & Study Coordinators
🔹 University Graduates & Career Changers in Clinical Research
🔹 Anyone looking to strengthen their industry communication skills

📅 Date: 22 Mar 2025 (Please Note: The date has changed to Saturday, March 22, 2025)
📍 Format: Live Virtual Masterclass. This 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.
⏳ Time: 2:30 pm AEST – 4:30 pm AEST
💰 Cost: $150 + GST

📃Certification: Each attendee will receive a certificate of completion to boost your CV and enhance your employability.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), 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 during registering.

✨ Early Bird Discount: Save 20% when you register before 14 Mar 2025!
✨ Group Discount: Enrol with 2 or more colleagues and save 30%!

📢 Referral Bonus!

Share this event with your network! For every friend or colleague you refer who registers, you’ll receive an addition 10% discount on your own ticket! Plus, the person you refer will get a 10%

special discount too!