Navigating Clinical Trials: Clinical Trial Master File (TMF/eTMF) and FDA Requirements
Uncover Essential Documents for a Compliant TMF & Ease Through FDA Audits!
Instructor :
Carolyn Troiano
Webinar ID:
10818
Date: JUN 05, 2024 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Overview and Rationale Behind Trial Master File (TMF or eTMF).
- Required TMF Content for Clinical Trials Explained.
- Clinical Trial Essential Files (Before, During, After Trial)
- Demonstrating Regulated Activities Through Essential Documents.
- Organizing and Maintaining a TMF Effectively.
- “GxP” Systems, Validation Maintenance
- Quality Assurance Methods for….
-
- Overview and Rationale Behind Trial Master File (TMF or eTMF).
- Required TMF Content for Clinical Trials Explained.
- Clinical Trial Essential Files (Before, During, After Trial)
- Demonstrating Regulated Activities Through Essential Documents.
- Organizing and Maintaining a TMF Effectively.
- “GxP” Systems, Validation Maintenance
- Quality Assurance Methods for TMF Data.
- Standard Operating Procedures (SOPs) Supporting TMF: Requirements and Implementation.
- Consistent System for Locating TMF Documents Developed.
- FDA ER/ES Draft – Clinical Investigations
- Industry Standards and Best Practices in TMF Management
Course Description
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. FDB3142
This in-depth session is tailored specifically for professionals eager to enhance their expertise in clinical trials and regulatory compliance.
Why Attend?
-
- Comprehensive Understanding: Grasp the intricacies of Trial Master File (TMF) systems — the backbone of successful clinical trials. Learn how to efficiently manage, store, and monitor essential documents that meet FDA scrutiny.
- Regulatory Expertise: Stay ahead of the curve with detailed insights into FDA requirements. Our experts will guide you through the latest regulations and updates, ensuring your projects withstand regulatory challenges.
Key Takeaways:
-
- Streamline TMF Operations: Techniques to optimize document management for quicker access and improved audit readiness.
- Risk Management: Proactive strategies to identify and mitigate potential risks associated with TMF and FDA audits.
- Latest Trends and Innovations: Explore how emerging technologies and trends are reshaping TMF management.
Join Now!
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. FDB3142
This in-depth session is tailored specifically for professionals eager to enhance their expertise in clinical trials and regulatory compliance.
Why Attend?
-
- Comprehensive Understanding: Grasp the intricacies of Trial Master File (TMF) systems — the backbone of successful clinical trials. Learn how to efficiently manage, store, and monitor essential documents that meet FDA scrutiny.
- Regulatory Expertise: Stay ahead of the curve with detailed insights into FDA requirements. Our experts will guide you through the latest regulations and updates, ensuring your projects withstand regulatory challenges.
Key Takeaways:
-
- Streamline TMF Operations: Techniques to optimize document management for quicker access and improved audit readiness.
- Risk Management: Proactive strategies to identify and mitigate potential risks associated with TMF and FDA audits.
- Latest Trends and Innovations: Explore how emerging technologies and trends are reshaping TMF management.
Join Now!
Why you should attend
In the dynamic field of clinical trials, staying updated with the latest regulatory standards and efficient TMF systems is crucial for success.
Here’s why this webinar is an invaluable opportunity for your professional growth:
-
- Deep Dive into TMF Systems: Understand the core functions and best practices of Trial Master File management. Our detailed walkthrough will help you streamline processes, enhance efficiency, and maintain impeccable compliance records that meet FDA expectations.
- Regulatory Insights: The landscape of clinical trials is continuously evolving with new FDA regulations. We provide you with the most current and comprehensive insights, preparing you to handle audits with confidence and ensuring your documentation is audit-ready at all times.
Key Advantages of Attending:
-
- Practical Knowledge: Gain actionable strategies that can be immediately implemented to improve your TMF management and compliance processes.
- Expert Guidance: Learn from industry leaders who have navigated the complexities of clinical trials and have hands-on experience with the FDA’s stringent requirements.
- Future Preparedness: Equip yourself with the knowledge to adapt to future changes in regulations and technological advancements in TMF systems.
Join our community of forward-thinking professionals and take a significant step toward mastering the complexities of clinical trials.
Register now to secure your spot in this essential webinar designed to propel your career forward!
In the dynamic field of clinical trials, staying updated with the latest regulatory standards and efficient TMF systems is crucial for success.
Here’s why this webinar is an invaluable opportunity for your professional growth:
-
- Deep Dive into TMF Systems: Understand the core functions and best practices of Trial Master File management. Our detailed walkthrough will help you streamline processes, enhance efficiency, and maintain impeccable compliance records that meet FDA expectations.
- Regulatory Insights: The landscape of clinical trials is continuously evolving with new FDA regulations. We provide you with the most current and comprehensive insights, preparing you to handle audits with confidence and ensuring your documentation is audit-ready at all times.
Key Advantages of Attending:
-
- Practical Knowledge: Gain actionable strategies that can be immediately implemented to improve your TMF management and compliance processes.
- Expert Guidance: Learn from industry leaders who have navigated the complexities of clinical trials and have hands-on experience with the FDA’s stringent requirements.
- Future Preparedness: Equip yourself with the knowledge to adapt to future changes in regulations and technological advancements in TMF systems.
Join our community of forward-thinking professionals and take a significant step toward mastering the complexities of clinical trials.
Register now to secure your spot in this essential webinar designed to propel your career forward!
Course Agenda
Trial Master File (TMF) Overview:
-
- Understand the background and rationale behind TMF to grasp its critical role in clinical trials.
TMF Content Requirements:
-
- Learn precisely what content is essential for a TMF in a clinical trial.
Essential Documents:
-
- Identify the key documents that must be included in a TMF and their role in demonstrating the regulated activities of both the investigator and sponsor.
TMF Organization and Maintenance:
-
- Discover strategies for effectively organizing and maintaining your TMF for ease of access and compliance.
Quality Assurance:
-
- Learn how to ensure the quality and accuracy of the data within your TMF.
Standard Operating Procedures (SOPs):
-
- Understand the SOPs required to support and enhance TMF management.
Document Location System:
-
- Develop a consistent and efficient system for locating TMF documents quickly.
Regulatory Inspection Preparedness:
-
- Prepare for regulatory inspections by ensuring your TMF records are compliant and readily accessible.
Industry Standards and Best Practices:
-
- Explore the latest industry standards and best practices to keep your TMF up-to-date and compliant.
Interactive Q&A Session:
-
- Engage with experts and peers in an interactive Q&A session to discuss specific challenges and solutions.
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Trial Master File (TMF) Overview:
-
- Understand the background and rationale behind TMF to grasp its critical role in clinical trials.
TMF Content Requirements:
-
- Learn precisely what content is essential for a TMF in a clinical trial.
Essential Documents:
-
- Identify the key documents that must be included in a TMF and their role in demonstrating the regulated activities of both the investigator and sponsor.
TMF Organization and Maintenance:
-
- Discover strategies for effectively organizing and maintaining your TMF for ease of access and compliance.
Quality Assurance:
-
- Learn how to ensure the quality and accuracy of the data within your TMF.
Standard Operating Procedures (SOPs):
-
- Understand the SOPs required to support and enhance TMF management.
Document Location System:
-
- Develop a consistent and efficient system for locating TMF documents quickly.
Regulatory Inspection Preparedness:
-
- Prepare for regulatory inspections by ensuring your TMF records are compliant and readily accessible.
Industry Standards and Best Practices:
-
- Explore the latest industry standards and best practices to keep your TMF up-to-date and compliant.
Interactive Q&A Session:
-
- Engage with experts and peers in an interactive Q&A session to discuss specific challenges and solutions.
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Maximize the Learning Experience in A Group Setting!
- 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
Maximize the Learning Experience in A Group Setting!
- 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
Instructor Profile
Carolyn (McKillop) 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 is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
