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Research-Regulatory Affairs News

  • Failure to Report: A STAT Investigation on ClinicalTrials.gov

    • 12.15.2015

    Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found. The violations have left gaping holes in a federal database […]

  • Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

    • 05.28.2015

    Reliable approaches to monitoring are critical, and although a variety of monitoring approaches are available for overseeing clinical trial conduct, the most common approach remains frequent visits to each clinical trial site. During the past two decades, there has been a dramatic global increase in the number and complexity of clinical trials. In 2013, the […]

  • GCPartner App Now Available

    • 05.28.2015

    The new GCPartner app is now the must have app for all researchers involved in Good Clinical Practices (GCPs).    Have the  GCP’s at your finger tips no matter where you are at.  For more information on how to get this free app click here…..

  • FDA Issues Guidance on Laboratory Developed Tests (LDT’s)

    • 02.12.2015

    Laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. […]