The Drug Information Association (DIA) today announced the availability of version 1.0 of the Trial Master File (TMF) Reference Model.
The TMF Reference Model presents a consensus position regarding the required content of the TMF, using standardized nomenclature, to include all essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced, in accordance with industry opinion and best practices.
The model, which extends beyond section 8 of ICH E6 (R1) Guideline for Good Clinical Practice, also provides suggested taxonomy (structure) and relevant metadata. It consists of Excel spreadsheets documenting the content, an overview which explains how to interpret the TMF Reference Model and a formal feedback mechanism.
The TMF Reference Model can be used and adapted by any organization involved in the management of TMFs for clinical studies, if they so choose. If used, it allows for standardization across the industry. As it does not prescribe any specific structure, it can be adapted to any electronic or paper TMF and does not endorse, nor require, any specific technology for application.
Although the Model is not a regulation or official guidance, it provides an established method with which to overcome the challenges of different TMF terminology and file structures that create inefficiency and a higher degree of variability when collaborating with business partners and during inspections or audits.
The TMF Reference Model is a valuable tool for:
- Biopharmaceutical sponsors of any size, both commercial and institutional, involved in clinical studies
- Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
- Contract Research Organizations and vendors servicing TMFs, including technology providers
- Site staff, including investigators and coordinators
- Regulatory inspectors and auditors who conduct inspections and audits involving TMFs
“DIA strives to serve as a knowledge resource for the dissemination of information to help professionals overcome some of their most challenging issues,” explains Paul Pomerantz, DIA Worldwide Executive Director. “With the support of an engaged group of industry leaders, our Document and Records Management SIAC [Special Interest Area Community] has published a valuable resource for the clinical research community.”
The TMF Reference Model team, part of the DIA Documents and Records Management SIAC, consists of more than 130 professionals from 91 biopharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, healthcare institutions, academia, non-profits/NGOs and regulatory agencies across Europe and North America. “Bringing together so many organizations and so much expertise to form a consolidated reference for the Trial Master File is significant for the clinical research world,” says Karen Redding, Global Business Development Director at Phlexglobal. “As more and more companies adopt the model as a reference, it is hoped that the challenges that trial master files present will be significantly reduced.”
If you would like to join the TMF Reference Model Team please email Karen Redding at KRedding@phlexglobal.com.
ABOUT THE EDM REFERENCE MODEL
The EDM Reference Model was initiated by the Document and Records Management, Electronic Regulatory Submissions and Medical Writing SIACs. The Regulatory Submissions Reference Model Version 1.0 was released in June 2009. The Prescribing Information Reference Model is in development. The Pharmacovigilance Reference Model working group is in the process of forming.
The EDM Reference Model is intended to provide a flexible, open, free and sustainable model to facilitate the implementation of electronic document management systems or transferring dossiers between companies through partnerships or acquisitions. The TMF Reference Model is an extension of the EDM Reference Model.
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.