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Description

Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Understanding the Essential Clinical Trial Files Necessary for a Trial Master File (TMF) Created to Support an FDA-Regulated Clinical Trial

Understanding and Leveraging Electronic Trial Master File (eTMF) Capability to Improve Efficiency and Effectiveness of Maintaining a TMF During the Conduct of an FDA-Regulated Clinical Trial

Understanding the Latest Guidance for Using Electronic Records (ER) and Electronic Signatures (ES) During Creation and Maintenance of a Trial Master File (TMF) During the Conduct of an FDA-Regulated Clinical Trial

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.

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 an eTMF.

The Code of Federal Regulations states in 21 CFR 312.50:

“Sponsors are responsible for… ensuring that the investigation(s) are 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 the FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is 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 the FDA, and will also be discussed.
Finally, we will cover the new DRAFT Guidance from the FDA on the Use of Electronic Records and Electronic Signatures (ER/ES) in Performing Clinical Trials.

Learning Objectives:-

Learn how to identify “GxP” Systems that feed into a TMF/eTMF
Learn about FDA’s current thinking about technology and software development, and how this will impact the industry in relation to TMF/eTMF systems
Understand the complexities and challenges of validating systems used in clinical trial work, and how to strive for greater interoperability of the many systems involved, and streamline the workflows
Understand the importance of developing a data governance approach to managing the vast amounts of data and documents generated as part of a clinical trial
Learn about electronic Trial Master Files (TMFs) and how these should be prepared, including the essential documents for three phases of a trial: before starting, during execution, and after completion of work
Learn about the System Development Life Cycle (SDLC) approach to validation, and how the traditional Computer System Validation (CSV) and newer Computer Software Assurance (CSA) approaches compare
Learn the pros and cons of an Agile vs. Waterfall approach for System Development Life Cycle (SDLC) management
Learn about cloud computing and Software-as-a-Service (SaaS) systems that can be embraced and validated effectively to support clinical trial work
Understand SOC 2 Certification and Compliance for cloud-based services
Understand how to maintain a system in a validated state through the system’s entire life cycle
Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance for key systems used in clinical investigations based on risk assessment to ensure data integrity is maintained throughout the entire data life cycle.

Areas Covered in the Session:-

GxP Data and Computer Systems Regulated by FDA
Computer System Validation (CSV)
Computer Software Assurance (CSA)
Critical Thinking
The System Development Life Cycle (SDLC) Methodology
Risk Assessment & Management
GAMP˚5, 2nd Edition and Software Categorization
21 CFR Part 11 FDA Guidance for Use of Electronic Records & Electronic Signatures (ER/ES) During Conduct of a Clinical Trial
Validation Strategy and Planning
Requirements Specification (RS)
Design/Configuration Specifications
Installation Qualification (IQ)
User Acceptance Testing (UAT)
Maintenance and Operational Support of FDA-Regulated Computer Systems
Policies and Procedures to Support CSV, including Change Control, Risk Management, Incident Reporting and Disaster Recovery (DR) Planning
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 Procedures (SOPs) are required to support a TMF/eTMF
Inspection of TMF records
Electronic TMF (eTMF)
Q&A.

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) or electronic trial master file (eTMF).

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, including managing data with integrity. An eTMF may be used to leverage technology and automation during the collection and maintenance of a TMF.

Documents contained in the TMF/eTMF 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.

The latest draft guidance for using Electronic Records (ER) and Electronic Signatures (ES) while creating and maintaining a TMF provides guidance for meeting FDA’s 21 CFR Part 11 guidance for use of ER/ES in FDA-regulated activities.

Why Should You Attend?

Anyone involved in a clinical investigation with responsibility for data, documents, and other artifacts that must be created and maintained with integrity must understand how systems interact, how data flows, and how these critical assets are managed through their entire life cycle. In particular, they are regulated by the FDA and must meet all Agency requirements, including those for validation, 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures, data integrity, and Good Clinical Practice (GCP).

Whether you are working for a Clinical Trial Sponsor, a Contract Research Organization (CRO), a laboratory testing clinical trial samples, or in any way involved in the mechanics of setting up and managing a clinical TMF or eTMF, you will benefit by learning about how to meet compliance, improve the quality of data, documents, and artifacts, and reduce overall costs.

The latest draft guidance on the use of ER/ES during creation and maintenance of a TMF regulated by the FDA will ensure that 21 CFR Part 11, the FDA’s guidance for use of ER/ES in regulated activities, is met.

Who Will Benefit?

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
Clinical Trial Sponsors
Clinical Trial Participants
Contract Research Organizations (CROs)
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Auditors engaged in internal and external inspections and compliance
Vendors responsible for software development, testing,g and maintenance
Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance.

Clinical Trial Systems: TMF and eTMF, and FDA’s Recent Draft Guidance for Electronic Records/Signature

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