Supporting Open Access for Researchers
*Michael Pencina, Duke Clinical Research Institute 

Keywords: Supporting Data Access for Researchers (SOAR)

There are growing calls for increased access and transparency of clinical data. The recent report from the Institute of Medicine (IOM) outlined several key features of this process. In response, the Duke Clinical Research Institute (DCRI) through its new SOAR (Supporting Open Access for Researchers) initiative aims to facilitate open sharing of trial data with interested researchers. SOAR specifically focuses on several key areas underscored in the IOM report, including an independent review committee that ensures expert consideration of each proposal; stringent data de-identification and protection of patient privacy; promotion of pre-specified statistical analysis plans (SAP); and independent review of final manuscript prior to submission. In this presentation we will present details of the SOAR model and comment on several outstanding aspects of the IOM report.