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Trial Master File (TMF): FDA Expectations from Sponsors and Sites
- 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
Overview of the webinar
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.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- 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
Why should you attend?
Anyone responsible for handling trial documentation or quality assurance activities.
Faculty - Miss.Sarah Fowler Dixon
Sarah Fowler-Dixon, PhD, CIP currently works with the human research protection program at Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, guidelines, reporting, and training for researchers and staff. She often works with state and federal authorities such as the NIH and FDA. She has provided 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 mentors honors students in the Clinical Research Management program.