Trial Master File and Clinical Data Management Regulated by FDA

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 (TMF).

• 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

• Lead CRAs
• CRA Managers
• Project and/or Study Managers
• Project and/or Clinical Trial Assistants
• Clinical Operations Administrators
• Quality Assurance Personnel
• Auditors
• Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
• Consultants working in the life science, tobacco and related industries who are involved in computer system implementation, validation and compliance

Instructor Profile:

Carolyn Troiano

ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience 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, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.