eDeviation

What it does

eDeviation supports all the operations for Protocol Deviation assessment and management. eDeviation relieves your clinical team from the risks associated with missing or wrongly assessing one-time or recurring protocol deviations.

A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the approved protocol, consent document, recruitment process, or study materials (e.g. questionnaires) originally approved by the IRB. Protocol deviation is a general term and includes, protocol exceptions, changes made to avoid immediate harm to subjects, and protocol violations. Protocol d

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…from protocoldeviation.com

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