As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
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, ...
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