The TMF Reference Model is an opportunity for harmonization across the industry in terms of content, naming and structure.
The Trial Master File (TMF) Reference Model presents a single, unified interpretation of the regulations and best practices by the TMF Reference Model Team regarding the content of a Trial Master File 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 regulatory requirements, industry opinion and best practices.
The Trial Master File Reference Model was started in 2009 by Karen Roy and Lisa Mulcahy and today the team is composed of representatives from more than 165 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, not-for-profit / NGO and regulatory agencies. It is managed by a Steering Committee of 14 members from across the Industry.
To support the exchange of TMF content between sponsors, CROs and other stakeholders, a TMF Reference Model sub-team has developed an eTMF Exchange Mechanism Standard as a specification for transferring TMF data between different eTMF systems.
Phlexglobal are delighted to announce that PhlexTMF has the built in capability to support the EMS.
Please visit the TMF RM website for more information.