Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing
Duration : 90 Minutes
Carolyn Troiano,
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. Du Read more
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This seminar will help you understand in detail the new requirements for trial master files.
Course Objectives:
• Learn what content is required for a TMF for a clinical trial
• Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
• Learn how to establish and maintain a well-organized TMF, and provide quality assurance for the data included
• Understand the importance of developing an effective Standard Operating Procedure (SOP) to support TMF activities
• Learn the importance of developing a consistent system for locating TMF documents, and preparing them for study team use or regulatory inspection
• Learn about best practices and industry standards
Why Should You Attend:
You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.
Course Outline:
• Trial Master File (TMF) background and rationale
• The essential documents to include in a TMF
• Organizing and maintaining a TMF
• Standard Operating Procedure required to support TMF
• Inspection of TMF records
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
