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premier research clinical trial clinical research clinical trials fda pediatric regulations paediatric investigation plans patient recruitment data management ema pediatric clinical research. paeditric research patient retention pediatric clinical trials parental permission informed consent pediatric assent pip prea medical writing jacqueline zarro site selection feasibility sdtm regulatory submission adam cdisc cdash electronic data capture edc epro iwrs randomization ivrs interactive response technologies interactive voice response irt ron kershner dsmb data monitoring committees dmc pediatrics paediatric investigational plans contract research organization paediatric assent pediatrics regulations pmdsia paediatric pips susan bhatti regulatory affairs enrollment marilyn ingram ind cindi stout saps anita frijhoff cro