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Session 2: Global Approaches of Data Sharing and ICMJE Data Sharing Requirements
Session Chair(s)
Robert Paarlberg, MS
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)
PhUSE Update and Industry Perspective on ICMJE’s Data Sharing Requirements
Elizabeth Roberts, MSc
UCB Inc., United States
Data Policy and Privacy Lead
Data Sharing Statements
Pamela Miller
New England Journal of Medicine, United States
Special Projects
Data Sharing Statements: Considerations for Academic Medical Centers
Anthony Keyes, MBA, PMP
Johns Hopkins University, United States
Program Administrator, Clinical Research Operations