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DIA Trial Master File Reference Model

DIA Trial Master File Reference Model. EDM Reference Model. DIA Document and Records Management Special Interest Area Community initiative since 2008 Standardization effort for the industry with eCTD backbone Version 1 launched in 2008, update in the works

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DIA Trial Master File Reference Model

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  1. DIA Trial Master File Reference Model

  2. EDM Reference Model DIA Document and Records Management Special Interest Area Community initiative since 2008 Standardization effort for the industry with eCTD backbone Version 1 launched in 2008, update in the works Extensions of the model are in development Interconnects with TMF Reference Model in trial related submission documentation Ensure mapping of taxonomy and alignment of metadata

  3. Why a TMF Reference Model? • ICH GCP Section 8.2 – 8.4 • “The minimum list of essential documents that has been developed.....” • ICH GCP does NOT provide a comprehensive contents list for the TMF • Examples of missing documentation: • Electronic systems • Data management and statistical methodology • Safety monitoring

  4. The Trial Master File Supporting files e.g. computer SDLC files; GMP manufacturing files; vendor selection files Minimum list of essential documents, as defined by ICH GCP, Chapter 8 Usually considered outside the scope of the TMF The Trial Master File Other trial-related records that “permit evaluation of the conduct of the trial and quality of data produced” Other business records

  5. TMF Reference Model Goals

  6. 1.5 years of Accomplishments

  7. How Work on the Model is Organized?

  8. Who’s Been Involved? • 139 members on team • 55% US, 45% EU • 98 Companies • Pharma • CRO • Vendor • Regulatory agency review • MHRA • FDA

  9. TMF Reference Model Version 1.0 Overview

  10. Artifact Definition

  11. Core / Recommended, ICH & EDM

  12. Metadata

  13. Overall Model

  14. Using the TMF Reference Model for paper

  15. Future Plans • Linked in group (TMF Reference Model) • Continued connection with industry representatives • Coordinated feedback on the utilization of the model by sponsors, CROs, and vendors • Version 1.1 expected by Dec 2010 / early 2011 • Technical guide to the model • Version 2.0 of model expected by June 2011 may include: • Device Studies • Early phase studies • Investigator Initiated Studies • Regional expansive view

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