OHM20 is spot on…study sites have a principal investigator assigned before study start-up, who both reviews “events” that may have been reported elsewhere they need to be aware of, and they render an opinion as to whether serious events in any of their trial participants would more than likely represent underlying disease processes vs the drug. Any serious events do get reported up to the IRB and DSMB. I think the hold has more to do with safety data aggregation that was lacking to properly inform physicians reviewing drug for prescribing purposes…think in terms of drug inserts for prescribers, which would be carefully scrutinized by the FDA prior to any formal approval.