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Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF) Management and FDA Compliance

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF) Management and FDA Compliance

Duration: 90 Minutes

Faculty: Carolyn Troiano      Level: Intermediate      Course ID: 1098


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.  Alternately, an electronic Trial Master File, or eTMF, can be used to collect/create and manage all of the necessary data and documentation.  We will discuss the benefits and challenges of moving to an eTMF, or maintaining a hybrid solution that includes both a paper TMF and eTMF.

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.  More recently, tobacco and tobacco related products have come under regulation by FDA, and will also be discussed.

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:

  • GxP Data and Computer Systems Regulated by FDA
  • Computer System Validation (CSV)
  • The System Development Life Cycle (SDLC) Methodology
  • Risk Assessment
  • GAMP 5 Software Categorization
  • Validation Strategy and Planning
  • Functional Requirements Specification (FRS)
  • Design/Configuration Specifications
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • System Acceptance and Notification of Release into Production
  • Maintenance and Operational Support of FDA-Regulated Computer Systems
  • Policies and Procedures to Support CSV
  • Training and Organizational Change Management (OCM) Supporting CSV Activities
  • 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
  • Electronic TMF (eTMF)
  • Q&A

Who Will Benefit:

  • 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
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above

College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements.

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

  • Pharmaceutical
  • Medical Device
  • Biologicals
  • Tobacco
  • E-Liquid/Vapor
  • E-Cigarette
  • Cigar
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)

Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA.

Topic Background:

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).  All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle.  Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.


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Sr. FDA Consultant
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.