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 ...
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, ...
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not ...
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