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.
Protocol Deviations Glossary Page
The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.
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Clinical Protocol Deviations FDA / EMA Regulations
Helpful links to the FDA and EMA guidance documents that address the difficulties raised by protocol deviations in clinical trials.
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Protocol Violations Tools, Resources and Templates
We have assembled a useful repository of links to useful resources to you on your Protocol Violations exploration.
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