Four years lat­er, FDA fi­nal­izes guid­ance on risk-based mon­i­tor­ing of clin­i­cal tri­als

How much or how lit­tle over­sight is nec­es­sary for a clin­i­cal tri­al to suc­ceed? That’s the bil­lion-dol­lar ques­tion the FDA hopes to help in­dus­try bet­ter un­der­stand as the agency on Tues­day re­leased an al­most com­plete­ly rewrit­ten fi­nal guid­ance on the risk-based mon­i­tor­ing of clin­i­cal tri­als.

While ad­mit­ting that its own “reg­u­la­tions are not spe­cif­ic about how spon­sors are to con­duct mon­i­tor­ing” of clin­i­cal tri­als, and build­ing off a 2013 guid­ance, the FDA us­es its Q&A guid­ance to con­tin­ue to call for a risk-based ap­proach in­formed by the spon­sor’s “over­ar­ch­ing qual­i­ty man­age­ment” sys­tem and as­so­ci­at­ed in­ves­ti­ga­tion­al plans that “should be ad­just­ed through­out the con­duct of the in­ves­ti­ga­tion as need­ed.”

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