standard operating procedure pharmacovigilance microdosing human subject research retrospective cohort study intention-to-treat analysis vaccine trial crossover study clinical research adverse event validation (drug manufacture) pearl index good clinical practice inclusion and exclusion criteria clinical research associate case series investigational new drug case report form treatment and control groups james lind common technical document postmarketing surveillance serious adverse event placebo-controlled study medical writing electronic data capture pragmatic clinical trial cluster randomised controlled trial clinical trial management system investigator's brochure clinical data interchange standards consortium source document lost to follow-up patient-reported outcome stepped-wedge trial clinical research coordinator data monitoring committee prioritization analysis of clinical trials electronic common technical document expanded access clinical study report placebo in history population study multicenter trial run-in period monitoring in clinical trials clinical data management system minimisation (clinical trials) council for international organizations of medical sciences approved drug non-specific effect of vaccines biodistribution privacy for research participants in silico clinical trials glossary of clinical research clinical investigator clinical trials publication haybittle– peto boundary pocock boundary functional assessment of cancer therapy - general ( f a c t- g) data clarification form standard treatment assay sensitivity zelen's design good clinical data management practice community advisory board
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