Beginner's Guide to Clinical Trial Master File Essentials

  • Tutor: R. Malle
  • Level: Beginner
  • Study time: 4.5 hours
  • Video time: 4.5 hours
  • Exams: 1
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WHAT'S INCLUDED ?

Regulatory Framework and Compliance:

Understanding international regulations and guidelines governing clinical trials, including ICH-GCP, FDA, and EMA standards.

Essentials of CTMF Management

Detailed exploration of the structure, content, and importance of the Trial Master File in clinical trials.

Document Management and Archiving

Techniques for effective management, storage, and archiving of clinical trial documents to ensure integrity and accessibility.

Electronic Trial Master File (eTMF) Systems

Training on state-of-the-art eTMF systems, focusing on digital organization, security, and data retrieval.

Quality Control and Audit Readiness

Strategies for maintaining CTMF quality and preparing for internal and external audits.

Real-world Case Studies and Interactive Scenarios

Practical, hands-on learning experiences based on real-life situations.

BENEFITS OF TAKING THIS COURSE.

Enhanced Expertise

Gain in-depth knowledge of study start-up processes and management strategies.

Career Advancement

Improve your qualifications for roles in clinical research coordination and management.

Practical Skills Application

Learn through practical examples and interactive modules for real-world application.

Networking Opportunities

Connect with industry professionals and peers in the field of clinical research.

Compliance Mastery

Become proficient in navigating regulatory requirements and ensuring study compliance.

Interactive Learning Experience

Benefit from an engaging, interactive learning environment with practical applications.

WHAT OUR STUDENTS SAY ABOUT THIS COURSE

Samantha J. (Clinical Research Coordinator)

Highly Informative and Engaging
     
The Clinical Trial Master File Management course was a game-changer for my career. The practical workshops and expert instructors provided me with invaluable skills and confidence to manage CTMFs effectively

Alex M.

A Game-Changer in My Career
     
As someone transitioning to clinical research, this course was fundamental in understanding the complexities of CTMF. The knowledge gained has been pivotal in my professional growth.

Rajesh K.

Exceeded My Expectations
     
This course offered a deep dive into CTMF management. The blend of theory and real-life case studies made learning engaging and highly applicable to my work.

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Created by

R. MALLE

With 10+ years of experience in various hospitals and pharmaceutical companies, Rudy has honed his expertise in multiple therapeutic areas and clinical trial phases. He has excelled in leadership roles, demonstrating a strong ability to train and guide teams effectively. His practical knowledge and commitment to excellence make him a key educator in the academy.
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