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FDA and OHRP are increasingly sharing information and trying to avoid doing duplicate audits of IRBs, officials told the annual PRIM&R conference in Washington Dec. 6.
While OHRP has the lead on IRB oversight over federally funded studies, FDA actually conducts more IRB inspections, mostly surveillance audits. FDA conducted 300 IRB inspections in fiscal 2002, with most--161--being conducted by the Center for Drugs. The Center for Devices handled 128 and Center for Biologics 11. Data on fiscal 2003 inspections are still not available.
"In terms of planning our surveillance we do coordinate with ORHP and look at it, and sometimes we do joint inspections, usually for cause," said Stan Woollen, associate director for bioresearch monitoring in FDA's Office of Good Clinical Practice.
"We try to ensure there is no overlap," Woollen said. He said CDER generally keeps the inventory of IRBs, but noted some IRBs "only handle medical device studies," so CDRH may order an IRB audit for …