The importance of Protocol Deviations monitoring in Your Trial

A protocol deviation (PD) is any change, divergence, or departure from the study design or procedures defined in the approved protocol, consent document, recruitment process, or study materials originally approved. Protocol deviations can be identified either programmatically from the collected clinical data or manually during monitoring visits. They reflect the compliance of investigational sites with the study protocol and can reveal systematic errors that may impact the validity of the study results.

Depending on the protocol complexity, an independent committee may be called upon to review PDs and suggest corrective measures. A web-based software platform is the best way to manage communication between the involved parties and implement corrective actions in a timely and targeted manner.