Clinical Trial Data Headaches

TitleClinical Trial Data Headaches
Publication TypeCase Study
Year of Publication2009
AuthorsStanford Biodesign, Stanford University,
PublisherStanford Biodesign, Stanford University
AbstractYou have developed a new device for the treatment of congestive heart failure and are working with a company you helped to create to complete the clinical trials of this device. Several of the other investigators at different institutions are collaborating you in testing the device, and many of them want to be able to keep primary patient data from the clinical trial in a database located on their site. The CEO of your company is worried that the other investigators might not take proper care of the data, many publish the results too early, or it might lead to differing data at several sights due to lack of consistent updating. The CEO asks you for your opinion on how to store and organize the data.
OEC Unique IdentifierEthics Case Studies in Biodesign
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