Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

Why Should You Attend:

The large majority of NDA and many 510(k) submissions are not submitted to the regulatory agencies in a timely manner due to issues with the Trial Master File (TMF). While clinical operations usually leads TMF efforts, staff throughout the company have responsibilities as part of the TMF, and the TMF cannot be closed until all members complete their required sections. Members of Data Management, Biostatistics, Medical Writing, CMC, Legal Affairs, Regulatory Affairs, Quality Assurance and others have documents or sections that they must complete and should be well aware of those requirements and formats of those documents before the study starts. These requirements are in effect whether it is a large, global Phase 3 study, a 10 subject Phase 1 study or a laboratory-based diagnostics study. It is this TMF which will get reviewed upon your submission and often by different reviewers not previously involved with your program when the studies occurred. It is also this TMF which is open for regulatory agency audits so it is important that you standardize what is and what is not in the TMF and the method that is used to collect the documentation.

This webinar will focus on the required parts and order of the TMF based on the type of investigational product, whether it is a pharmaceutical product, a medical device, or a diagnostic product. Roles and responsibilities of each study team member regarding TMF documentation requirements will also be discussed.

Areas Covered in the Webinar:

• The required parts and order of the TMF, specific to each industry
• How to perform continual quality assurance of the TMF to ensure early TMF closure
• Specific roles and responsibilities of each study team member regarding TMF documentation requirements
• TMF storage and security requirements
• How to choose a TMF format – paper vs electronic or digital
• Common pitfalls in TMF documentation
• What Regulatory Agencies are looking for during TMF review

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Any role within the pharmaceutical, medical device or diagnostics clinical development portion of a company who have responsibility in ensuring success of a clinical trial
• Clinical Operations personnel
• Data Management personnel
• C-level and VP-level personnel
• Regulatory Affairs
• Quality Assurance
• Legal Affairs
• Biostatistics

Instructor Profile:

Adam Ruskin, PhD, DVM, MPH is the founder of LabCRO, Inc., one of California's largest Clinical Research Organizations. Dr. Ruskin was a researcher at the Centers for Disease Control (CDC), an FDA Advisor, and two-time TEDMED award nominee for innovation. He is the creator of LabTracker, the industry's first system for tracking clinical trial samples from the time of patient sampling until result posting. He has lead all clinical, data management and biostatistics activities at 4 successful start-up pharmaceutical, biotech, and medical device and diagnostics companies, and now leads successful clinical and data management teams for his clients through LabCRO. As a leading industry speaker for over 20 years, he knows the details of what it takes to get investigational products approved, especially under required budgets and timelines of most companies.

Topic Background:

Anytime an investigational product is tested in a human population in a clinical trial a Trial Master File (TMF) must be created for that trial. It is this TMF which gets submitted to Regulatory Authorities when it comes time for the NDA or 510(k) submissions, and not just the study database and analysis. There are some differences in the requirements in the TMF based on the type of investigational product, whether it be a pharmaceutical product, a medical device, or a diagnostic product. TMFs can also be in paper format or electronic format but there can be significant benefits and costs to either method depending on the specific program.

Most TMFs take at least 6 months to clean up after the end of a clinical trial before they are ready to be submitted. However, knowing the TMF requirements prior to beginning any trial as well as determining document collection formats can lead to routine TMF closure within 1 week of a database lock with the exception of the Clinical Study Report. This permits filing of your pivotal clinical study data months ahead of time and minimizing staff and vendor costs for TMF clean-up.

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