15422 federal register vol 71 no 59 tuesday march 28 2006 notices center for drug evaluation and research hfd 40 5600 fishers lane rockville md 20857 301 594 6758 or joanne less devices radiological health hfz 403 9200 corporate blvd 20850 1190 supplementary information i background fda is announcing the availability of a document entitled guidance clinical trial sponsors establishment operation data monitoring committees dated intended to assist trials in determining when dmc needed study how such should operate addresses roles responsibilities operating procedures dmcs november 20 2001 66 fr 58151 announced draft on received number comments considered those carefully as was finalized final also incorporates editorial clarifying changes being issued consistent with s good practices regulation 21 cfr 10 115
