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Protocol Deviations and Serious Breach Expedited Reporting

Posted on May 19th, 2017 by in Pharmacovigilance

Protocol deviations will occur even with the best designed clinical trial protocols and investigator training. Although minimizing such protocol breaches is an absolute mandate for Clinical Trial Sponsors, there are specific deviations (usually qualified as “major”) which require expedited reporting if they impact patient safety. Continue reading “Protocol Deviations and Serious Breach Expedited Reporting” »