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DoubleTree Bethesdan

Sep 19, 2019 7:00 AM - Sep 20, 2019 3:15 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Session 2: Global Approaches of Data Sharing and ICMJE Data Sharing Requirements

Session Chair(s)

Robert  Paarlberg, MS

Robert Paarlberg, MS

Principal

United States

The ICMJE’s new data sharing requirements, requiring manuscripts contain a data sharing statement became effective July 1, 2018. The ICMJE also requires clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trial’s registration as requirement of manuscript acceptance by a journal. This session will provide an update from a journal editor regarding the journal’s experience with manuscripts they have received regarding the new data sharing requirement as well as experience from industry and academia regarding these new requirements.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the ICMJE new data sharing requirements
  • Describe how industry and academia are implementing the new requirements
  • Identify areas within their organization impacted by the new ICMJE requirements

Speaker(s)

Elizabeth  Roberts, MSc

PhUSE Update and Industry Perspective on ICMJE’s Data Sharing Requirements: Elizabeth Roberts, MSc

Data Policy and Privacy Lead

UCB Inc., United States

Pamela  Miller

Data Sharing Statements: Pamela Miller

Special Projects

New England Journal of Medicine, United States

Anthony  Keyes, MBA, PMP

Data Sharing Statements: Considerations for Academic Medical Centers : Anthony Keyes, MBA, PMP

Program Administrator, Clinical Research Operations

Johns Hopkins University, United States

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