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)
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 electronic version of the TMF, or the eTMF, is subject to the same requirements, and we will discuss options for establishing and managing eTMF documents
The Code of Federal Regulations states in 21 CFR 312.50
“Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.”
This seminar will help you understand in detail the new requirements for trial master files
Why Should You Attend:
You should attend this webinar if you are responsible for establishing or maintaining a TMF, or an electronic version of files (eTMF), 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.
Areas Covered in the Session :
- Learn what content is required for a TMF for a clinical trial
- Learn about the electronic version of managing key clinical trial master files, using an eTMF system
- 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
Who Should Attend:
- 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
Course Director: 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.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.