Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

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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. 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.

Areas Covered in the Session :

    • Trial Master File (TMF) background and rationale
    • Learn what content is required for a TMF for a clinical trial
    • The essential documents to include in a TMF
    • Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
    • Organizing and maintaining a TMF
    • How to provide quality assurance for the data included
    • Standard Operating Procedure required to support TMF
    • Developing a consistent system for locating TMF documents
    • Regulatory Inspection of TMF records and Preparation
    • Industry Standards and Best Practices
    • Interactive Q&A Session
Who Will Benefit:

    • Lead CRAs
    • CRA Managers
    • Project and/or Study Managers
    • Project and/or Clinical Trial Assistants
    • Clinical Operations Administrators
    • Quality Assurance Personnel
    • Compliance Teams
    • Validation Teams
    • Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
    • Consultants
    • Teams involved with CSV
    • Auditors engaged in the internal inspection of clinical trial documentation and practices

 

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. FDB2048

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.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
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