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Hotel Holiday Inn

May 23, 2016 9:00 AM - May 23, 2016 5:30 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

TUTORIAL 1 - ELECTRONIC TRIAL MASTER FILES (ETMF) – MORE THAN A DOCUMENT REPOSITORY

Overview

ELECTRONIC TRIAL MASTER FILES (ETMF) – MORE THAN A DOCUMENT REPOSITORY

Co-Instructors:

  • Eldin Rammell, Managing Director & Principal Consultant, Rammell Consulting, United Kingdom
  • Karen Jane Roy, Senior Vice President, Client Solutions Phlexglobal, United Kingdom

    With initiatives such as the TMF Reference Model, we have seen a significant increase in the level of knowledge, involvement and understanding in the area of trial master file management. Implementing an electronic trial master file is now regarded by many as an essential requirement. However, trial sponsors still struggle with many aspects of TMF creation, management and oversight. This tutorial will focus on just 3-4 topics related to the management of trial master files, providing delegates with extended time to review and discuss these subjects in detail. Whilst the instructors will provide an overview of each topic and will contribute their experience and expertise to the discussion, this will be highly interactive tutorial providing delegates an opportunity to discuss specific questions with their industry peers.

    Discussion topics may include*:

  • Selecting an eTMF vendor – what criteria should be considered?
  • TMF quality and compliance – what does it mean? what can you measure?
  • Eliminating paper records – can this be achieved?
  • Electronic versus digital signatures – which one wins?

    Learning Objectives

    At the conclusion of this tutorial, attendees will be able to:
  • Avoid common eTMF implementation issues
  • Evaluate the health of their TMF using industry standard metrics
  • Apply an efficient TMF process

    Target Audience

    Professionals involved in the following areas:

  • Clinical Records Managers/Archivists
  • eTMF Project Managers (IT & Business)
  • TMF Stakeholders

    * the exact content will depend on interests of registered delegates

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