Center for Global Research Data

Our Members

Duke University

About Our mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. Duke University School of Medicine is partnering with Vivli to foster the principles of open science and data access from clinical studies. Our data sharing goals and policies include:

  • Appropriate access to research information, so patient privacy is maintained, with the understanding that the nature of the study and sharing method will necessitate a range of privacy controls.
  • Proper oversight with minimum barriers to data access, to prevent against misuse of data, while promoting new discovery.
  • Maintaining utility of data, such that shared data can be used for new analyses.
  • An expectation that results of analyses from shared data will similarly be shared.
  • Acknowledgement of the work of original contributors.
Will individual participant data be available (including data dictionaries)?  Yes
What data in particular will be shared?  All of the individual participant data collected during the trial, after deidentification. 
What documents will be available?  If available, the following documents will be shared:

🗹 Study Protocol

🗹 Statistical Analysis Plan

🗹 Informed Consent Form

🗹 Clinical Study Report

🗹 Analytic Code

For what types of analyses?  To achieve aims in the approved proposal.  
By what mechanism will data be made available?  All datasets will be shared via the Vivli Platform. All datasets sharing proposals will be reviewed and approved by applicable Data Governance prior to sharing.