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Best Practices for TMF Filing and Maintenance Throughout Clinical Trials

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Description

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.

🎯 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.

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

Format, Date and Time

This is a paid online event. Current Clueo Clinical IBPTM trainees: please follow the instructions provided during your onboarding.

23 March @ 2:30 pm 4:30 pm Brisbane time

Attendees will receive access link and password before the event.

$150 plus GST and Fees

Clueo Clinical

1300398806

View Organizer Website

Clueo Clinical