Protocol Deviations Resources

Ethical Shares Everything We Know and
Continue to Learn About Protocol Deviations

Ethical understands the risks of protocol deviations in clinical trials and devotes a lot of time and effort to monitor developments in this field and communicate about them. 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 customers, their trials and the safety of the patients in those trials.

Useful Things to Know about Protocol Violation and How We Can Help You Succeed

Assessment and classification of protocol deviations

by RB Ghooi et al, 2016 Jul-Sep; 7(3): 132–136. […] As noted at our site, protocol deviations do take place. Though a majority are of minor nature and do not have significant impact, each deviation must be identified, reported, and analyzed for its impact [...] 


Protocol deviation and violation

by Arun Bhatt, Perspect Clin Res 2012; 3:117.  What is the difference between protocol deviation and protocol violation? Some suggested definitions and examples.


The Life Cycle and Management of Protocol Deviations 

by Mehra et al., Therapeutic Innovation & Regulatory Science 2014, Vol. 48(6) 762-777 […]Despite preventive efforts, protocol deviations are likely to occur in most trials. This position paper proposes a common definition of protocol deviations and recommends best practices […]. 


Failure to report protocol violations in clinical trials: a threat to internal validity?

by Sweetman, E.A., Doig, G.S., Trials 12, 214 (2011). [...] The purpose of this project was to gain a better understanding of reported PV rates, to describe current practice with regards to the use of methods for the reduction of PVs [...]


A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates.

by Jones C et al, Int J Clin Trials. 2018 Feb;5(1):30-36  […] A total of 45 monitoring reports were analyzed and coded for four types of deviations identified by monitors during specific monitoring visits […] 

Protocol Deviation Software

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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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Electronic Protocol Deviation Management Software

The Software Platform for Clinical Professionals Willing to Manage Protocol Deviations in a Fast and GxP Compliant Way

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