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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, MSc

Robert Paarlberg, MS, MSc

  • Principal
  • Paarlberg & Associates LLC, 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)

Liz  Roberts, MSc

PhUSE Update and Industry Perspective on ICMJE’s Data Sharing Requirements

Liz Roberts, MSc

  • Strategic Data Opportunities Policy 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 Manager, Clinical Research Projects
  • Johns Hopkins University, United States