A Trial Master File (TMF) is a collection of documents that describes the design, conduct, and results of a clinical trial. The TMF is a regulatory requirement for all clinical trials that are conducted in accordance with Good Clinical Practice (GCP). The TMF is used by sponsors, investigators, regulators, and other stakeholders to verify the conduct of the trial and to assess the quality of the data.
The TMF is typically organized into the following sections:
Study Protocol: This document describes the overall design of the trial, including the objectives, endpoints, and methods.
Investigator Brochure: This document provides detailed information about the trial to investigators, including the protocol, informed consent form, and other relevant information.
Conduct of Study: This section contains documents that describe the day-to-day conduct of the trial, such as case report forms, monitoring reports, and adverse event reports.
Study Results: This section contains documents that describe the results of the trial, such as statistical analysis reports, tables, and figures.
The TMF should be maintained in a secure and accessible location. It should be updated throughout the course of the trial to reflect changes to the protocol, conduct of the study, or results.
The TMF is an essential tool for ensuring the quality and integrity of clinical trial data. By maintaining a well-organized and up-to-date TMF, sponsors and investigators can help to ensure that their trials are conducted in accordance with GCP and that the data is reliable and reproducible.
Here are 5 TMF experts you can follow on LinkedIn to learn more about TMF events, in trends and best practices.
Nicole Palmer, MS, is the Founder of Granular Level, LLC, a Trial Master File (TMF) consulting firm on a mission to empower new and aspiring Trial Master File leads to get hired. Granular Level thrives on helping others meet their TMF goals and successfully navigate career transitions and the job search process. You can follow Granular Level on LinkedIn using this link.
Karen Roy a leading Trial Master File expert who is experienced in the management of clinical trials, processes and personnel with a focus on cost-efficiency, high quality and adherence to timelines. She is also co-leading on the TMF Reference Model initiative and chairing the Steering Committee responsible for standardising TMF contents, naming, structure and metadata globally. The group is now nearly 400 people. Karen spent 15 years working at Phlexglobal, reaching a position of Senior Vice President of Clinical Marketing, before launch her own company KJRoy Consulting.
Supriya Shoroff is the Director of TMF Operations at Elsai and she is a TMF/eTMF, CTMS and Clinical Systems expert. Prior to joining Elsai she was an Associate Director, Heading TMF Operations at AMAG Pharmaceutical, and an Associate Director of TMF Management at SAGE Therapeutics. She has more than a decade of experience in R&D within the pharmaceutical Industry and has led multiple agency Inspections. She has Implemented several eTMF systems, and has designed and developed business processes for effective eTMF management across various organizations.
Gillian Gittens is a Trial Master File and electronic Trial Master File subject matter expert, with significant experience in operations, project management, marketing, eTMF sales and client account management. She has worked with numerous global life science industry clients and has well over 20 years TMF focused experience. Gillian is a member of the TMF Reference Model Steering Committee, and was co-chair of the Quality Team for the DIA Framework for Paper Destruction Initiative.
Paul Fenton is the CEO of Montrium, where leads the overall vision for the connect platform which focuses on the organization and analysis of clinical trial information. He is a long standing member of the TMF Reference Model Steering Committee and Co-Chair of the eTMF Exchange Mechanism Standard working group. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.
These are just a few of the many TMF experts who are active in the pharmaceutical industry. By following these experts, you can stay up-to-date on the latest TMF trends and best practices.
Additionally, here are some benefits of having a well managed TMF:
Improved efficiency: A well-managed TMF can help to improve the efficiency of clinical trials by providing a central repository for all trial-related documents. This can help to reduce the time and resources spent searching for documents and can help to ensure that documents are not lost or misplaced.
Increased compliance: A well-managed TMF can help to ensure that clinical trials are conducted in accordance with regulatory requirements. This can help to reduce the risk of regulatory audits and can help to protect the integrity of trial data.
Improved quality: A well-managed TMF can help to improve the quality of clinical trial data by providing a clear and organized record of the trial. This can help to ensure that data is accurate and complete and can help to reduce the risk of errors.
Enhanced transparency: A well-managed TMF can help to enhance transparency by providing a clear and accessible record of the trial. This can help to build trust with stakeholders, such as patients, clinicians, and regulators.