A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...
Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports. An "incident" should be submitted ...
GlobalData on MSN
FDA protocol deviation guidance could go further
Protocol deviations can be extremely costly to clinical trials - both financially and with patient safety. In some cases, ...
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