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The What, Why and How of MetaTMF: Inspection Ready, Trial Enabling e/TMFs through Alignment of People, Process and Tools

Sep 21 2014 1:00PM - Sep 21 2014 4:30PM | Omni Shoreham Hotel 2500 Calvert Street NW, Washington, DC 20008 USA

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Overview 

This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file that enables continual inspection readiness and trial process enablement. In addition to covering foundation principles such as “what is an electronic trial master file” and “how can eTMF support inspection readiness surety and trial process enablement”, this interactive session will provide guidance in a wide range of related TMF Program considerations, including:

  • What the health authority regulations and guidances mean for eTMF systems and processes
  • How documents can best be processed in an eTMF
  • Metadata and naming conventions
  • How can eTMFs in-time quality can support end-users, auditors & inspectors
  • How eTMFs can support global clinical trial process enablement
  • How to drive out TMF paper management and implications of eTMFs e-signatures

For more information please follow this link.

Who Should Attend 

Professionals who are involved in:

  • Document and eRecords Managers
  • Clinical and Regulatory IT
  • Clinical Operations
  • Contract Research Organizations
  • Regulatory Affairs
  • Regulatory Operations

Learning Objectives 

At the conclusion of this tutorial, participants should be able to:

  • Recognize the principal regulatory eTMF requirements and guidances
  • Explain different requirements for full TMF program development
  • Develop user requirements for all stakeholders in TMF ecosystem
  • Recognize the impact of an eTMF on trial-related processes
  • Evaluate potential eTMF solutions

Contact Information 

Registration Questions
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Instructor(s) 

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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