Perla J Marang-van de Mheen, Thomas Woodcock
Grand rounds in methodology: four critical decision points in statistical process control evaluations of quality improvement initiatives
BMJ quality & safety
good clinical practice international standard design conduct clinical trials ensure ethical scientific integrity recent national institutes health policy mandates good clinical practice training investigators staff involved national institutes healthfunded clinical trials yet approaches good clinical practice training vary widely limited data good clinical practice knowledge among clinical trial workforce evidence regarding effective methods learn good clinical practice used exploratory sequential mixedmethods design conducted 18 exploratory qualitative interviews clinical research coordinators help inform development quantitative survey administered validated 32item multiplechoice test good clinical practice knowledge survey work training experiences 625 clinical research coordinators three academic medical centers united states variables significantly associated good clinical practice knowledge entered multiple regression analysis identify unique predictors good clinical practice knowledge controlled verbalnumerical reasoning learning orientation qualitative interviews clinical research coordinators reported formal good clinical practice training value simultaneously emphasized importance experience daytoday practice observing colleagues mentors essential supplement formal training quantitative survey five variables predicted total 22 variance good clinical practice knowledge scores years experience clinical research coordinator working diverse types trials supporting industryfunded trials certified clinical research coordination aggregated hours online facetoface training order duration richness experience clinical research coordinator strongest predictors good clinical practice knowledge finding consistent exploratory qualitative interview results findings suggest formal online facetoface training minimal influence good clinical practice knowledge type trainingwhether online face facedoes make significant difference good clinical practice knowledge scores much variance good clinical practice knowledge remains unexplained calling research area