Clinical Trial Systems 2022 - Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
Product Id : FDB3142
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Information Technology
Presenter : Carolyn Troiano
Scheduled On : February 03 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
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 Should Attend:
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.