56 Investigator Deficiencies Fiscal Years 1998 - 2005 19981999200020012002200320042005 Failure to follow investigational plan/regs 32%46%47%44% 51%54%50% Protocol deviations 21%8%26%40%20%38%16%9% Inadequate subject protection/IC 24%19%21%28%21% 24%29% Inadequate device accountability 17% 21%27%26%18%14%7% Lack of FDA &/or IRB approval 11%9%11%5%8%13% 10%