Protocol Deviations Resources

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 [...] 

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

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 […]. 

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 [...]

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 […]