A protocol deviation (PD) is any change, divergence, or departure from the study design or procedures defined in the protocol, consent document, recruitment process, or study materials originally approved.

This handbook will try to summarize the Protocol Deviation process, list the involved parties, describe the various methods and actions provisioned by regulations, and discuss tools and procedures that …

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. …

Here are helpful links to the FDA and EMA guidance documents that address the difficulties raised by protocol deviations in clinical trials.

A Complete Protocol Deviation Handbook that explains the process, lists the involved parties, describes the various methods and actions provisioned by regulations.

Whether your protocol deviation assessments are performed by an independent expert committee or by your study team, our eDeviation® software is configured to exactly match your needs.

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 …

Ethical is an eClinical software and services company that focuses on protocol deviation. Our approach is based on our staff’s experience in providing software solutions to support some 300 global clinical …

Ethical is a software and services company that focuses on protocol deviation. Contact Ethical for information on our software and services.

We are advocates of the protocol deviation review process because it is an important process that helps monitor for potential issues during the trial and because, ultimately, we care about the success of our …