Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Jun 18 |
01:00 PM ET / 12:00 PM CT / 11:00 AM MT / 10:00 AM PT | |
| Duration: 90 minutes | Speaker: Carolyn Troiano | |
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ABOUT THE EVENT
Companies involved in the conduct of human clinical trials must comply with a complex set of regulatory requirements to ensure the quality and integrity of clinical data. One critical aspect of compliance is the proper maintenance of trial documentation in a Trial Master File (TMF)—a collection of essential documents that demonstrate a sponsor’s adherence to Good Clinical Practice (GCP) and regulatory obligations throughout the lifecycle of a clinical trial.
This in-depth webinar will explore both traditional paper-based TMFs and electronic TMFs (eTMFs), covering their regulatory foundations, structure, and practical implementation. Attendees will learn how to manage documentation to support planning, conduct, and evaluation of clinical trials, with emphasis on preserving data integrity, ensuring inspection readiness, and meeting global standards across jurisdictions including the U.S., EU, and Japan.
The session will also address the evolving regulatory landscape, including the FDA’s recent draft guidance on the use of electronic records and electronic signatures in clinical trials. Additionally, the role of Computer System Validation (CSV) will be examined as a critical methodology to ensure system compliance and document integrity in electronic environments.
Why You Should 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.
Areas Covered
Areas Covered
- GxP Data and computer systems regulater 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 Should Attend
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Pharmaceutical
- Medical Device
- Biologicals
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor (based on the “Deeming” Act of 2016)
- E-Cigarette (based on the “Deeming” Act of 2016)
- Cigar (based on the “Deeming” Act of 2016)
- Third-Party companies that support those in the above industries
Personnel in the following roles will benefit:
- Legal
- Marketing
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection
Carolyn Troiano
Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.
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