Does your clinical investigator understand the consequences of non-compliance?
The increasing number and complexity of clinical trials, coupled with the recent increase in attention and enforcement from the U.S. Food and Drug Administration, arguably makes it more important than ever before that clinical investigators understand the regulatory requirements with which they must comply. This article outlines some of these requirements, common areas of non-compliance and FDA's enforcement options in dealing with such non-compliance. Finally, the article provides some suggestions for attaining and managing investigator compliance.
Donato
B J
BJ
Hyman, Phelps & McNamara, Irvine, California 92614, USA.
Gibson
T R
TR
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007587:Job Description; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D012108:Research Personnel / Q000193:education / Q000458:organization & administration* / Q000523:psychology*; D014481:United States; D014486:United States Food and Drug Administration