Clinical Trial Compliance for Computer Systems and Data Regulated by FDA - Trial Master File (TMF) and electron

Companies engaged in 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. 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 conducting 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.

Consolidated guidance for the 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 the 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.

Learning Objectives:-

This webinar will cover the following key areas:-

• 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
• Q&A

Areas Covered:-

• 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

Background:-

We will explore the documents and artifacts that should be considered essential to the Trial Master File (TMF) in terms of its content. We will also explore using an eTMF, and how various groups in the industry are working through standards and other types of frameworks. Next, we’ll understand the many types of computer systems that are used for clinical trial work, and how these must be validated in order to meet FDA compliance. We’ll also touch on the topic of 21 CFR Part 11, the FDA’s Guidance for Electronic Records and Electronic Signatures (ER/ES), to include ER/ES capability in trial work.

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.

Who Should Attend:-

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing, and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance