clinical trial process on blue

clinical trial process blue background phases informed consent protocol development study design participant recruitment randomization blinding placebo control interventional study observational population eligibility criteria site selection data collection adverse events monitoring analysis statistical endpoint primary outcome secondary protocol investigator initiated trial sponsor institutional review board irb ethical considerations patient enrollment visit procedures management case report form crf quality monitoring initiation drug investigational product drug safety research associate cra coordinator crc integrity database safety committee reporting lock closeout regulatory compliance budget documentation master file report publication