Clinical Trial Master File Compliance

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 webinar will help you understand in detail the new requirements for trial master files. The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50: "Sponsors are responsible for ensuring that the investigation(s) is/are conducted following the general investigational plan and protocols contained in the IND."

• 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

• 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
• Q&A

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.

Personnel in the following roles will benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.