Trial Master File (TMF): FDA Expectations From Sponsors And Sites

This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

This 60 minute’s webinar will help you to understand what are the essential documents that you should present before, during and after the trial.Participants will be also be able to understand what is a Trial Master File (TMF ) and an overview about (FDA) guidance and expectations, ICH guidelines and good clinical practice.

• Trial Master File (TMF): what is it?
• Essential documents required
• ICH guidelines and Good Clinical Practice (GCP)
• Food and Drug Administration (FDA) guidance and expectations
• Paper or electronic trial master files – what is allowable
• Links to useful resources.

The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws.

• Human Subjects Research
• Healthcare interested in exploring the field of Clinical Research
• New Clinical Research Coordinator positions (1-2 years)
• New Principal Investigator positions
• Administration in charge of Clinical Research
• Regulatory Compliance.

Sarah Fowler-Dixon, PhD, CIP has been working in the field of human research protections for over 14 years. During her tenure, Dr. Fowler-Dixon has developed a comprehensive human subjects education program which serves as a model for other institutions. Dr. Fowler-Dixon developed an executed a 2 day training session addressing NIH and FDA regulations, guidance and requirements for human subjects researchers. She has trained researchers, staff, and IRB members. She works with state and federal authorities such as the NIH and FDA. She provides consultation regarding ethical, federal, state, and institutional requirements in the design and execution of projects. Dr. Fowler-Dixon teaches research ethics and regulatory affairs, the fundamentals of clinical research management and was instrumental in establishing the Clinical Research Management program at Washington University’s University College.