Trial Master File (TMF) Maintenance in Clinical Trials

Description

Course Overview

A Trial Master File (TMF) is a collection of essential documents and records that document the conduct of a clinical trial. It serves as the primary repository for all documents related to the planning, execution, and monitoring of the trial, ensuring that the trial is conducted in compliance with regulatory requirements and good clinical practice (GCP) guidelines. Effective maintenance of the TMF is critical for ensuring the integrity, compliance, and transparency of clinical trials.

The Trial Master File (TMF) maintenance course provides participants with comprehensive knowledge and practical skills for organising, managing, and maintaining TMFs throughout the lifecycle of a clinical trial. Participants will learn best practices, regulatory requirements, and strategies for TMF maintenance to facilitate efficient trial oversight and audit/inspection readiness.

Key Learning Objectives

• Understand the purpose and importance of the Trial Master File (TMF) in clinical trials.
• Identify the essential components and structure of the TMF, including regulatory requirements and industry best practices.
• Learn regulatory requirements governing TMF maintenance, including ICH-GCP guidelines and local regulations.
• Develop strategies for organizing, managing, and maintaining TMFs to ensure compliance, efficiency, and transparency.
• Learn about TMF maintenance best practices including the TMF Reference Model.
• Implement TMF maintenance processes and procedures, including document collection, review, and archiving.
• Understand the role of electronic TMF (eTMF) systems and platforms in TMF maintenance and management.
• Prepare TMFs for regulatory inspections and audits, including strategies for inspection readiness and addressing common findings.
• Establish TMF metrics to monitor TMF quality and completeness.
• Gain practical skills and knowledge to effectively manage and maintain TMFs to support the successful conduct of clinical trials.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 40 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.

Target Audience

This program is ideal for professionals involved in overseeing the conduct of clinical trials and ensuring TMF compliance with regulatory requirements such as Clinical Research Associates (CRAs), Clinical Trial Managers, Clinical Trial Assistants (CTAs) or Clinical Research Administrators, Investigators and Site Staff including Clinical Research Coordinators (CRCs).

Prerequisite

Having prior knowledge of ICH-GCP guidelines and the regulatory framework governing clinical trials is beneficial as it enables you to apply the knowledge obtained from this course effectively.

Certification

• To receive the completion certificate for the course, you must achieve a minimum score of ≥ 80% on all assessments.
• You have the opportunity to attempt the final course exam twice. If you do not pass after both attempts, you will be required to retake the entire course from the beginning.

Upon meeting these criteria, your certificate of successful completion will be awarded within 48 hours of course completion.

Course Fee

Full fee: $928 inc. GST *

Industry partner: $743 inc. GST *

Member: $789 inc. GST *

(*Prices are subject to the indexation rate set by the Australian Taxation Office to account for inflation)