A recently published finding from investigations by federal regulators [Human Res Rept, Sep. 2016, 31(9), 9]:
- The U.S. Food & Drug Administration (FDA) found that a physician-investigator conducting two GlaxoSmith-Kline multisite studies of albiglutide (to treat diabetes) failed to follow the investigational plan. Specifically, FDA’s Warning letter found that an ineligible subject was enrolled and received a dose correction after screening, rather than within the specified time frame. The investigator’s response can be paraphrased as “I promise to do better next time.” FDA was unable to determine whether this corrective action was adequate to prevent similar violations in the future.
If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.