Trial Master File (TMF): FDA Expectations From Sponsors And Sites -BY AtoZ 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).

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 conducted in accordance with the general investigational plan and protocols contained in the IND.”

The European Directive 2005/28/EC states:

“…trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.”

ICH GCP, Section 8.1 describes “essential documents” as those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.

A consolidated guidance for industry on Good Clinical Practice (GCP) in 1996 was published by the International Conference on Harmonization (ICH). The objective was to provide a unified standard for the United States, European Union, and Japan to facilitate mutual acceptance of clinical data by the regulatory authorities in these global jurisdictions.

The ICH document provided guidance for companies in all ICH regions to establish trial master files that contain key documents that enable the evaluation of the conduct of a trial and the quality of data produced uniformly by all jurisdictions involved. In the US, there is no specific requirement from FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.

Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics and medical devices.

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.

Areas Covered In This Webinar

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

Learning 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

Who Will Benefit

Lead CRAs
CRA Managers
Project and/or Study Managers
Project and/or Clinical Trial Assistants
Clinical Operations Administrators
Quality Assurance Personnel
Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
Auditors engaged in the internal inspection of clinical trial documentation and practices
Consultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and management

Speaker and Presenter Information

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, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.