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. Author manuscript; available in PMC: 2021 Sep 1.
Published in final edited form as: Ther Innov Regul Sci. 2020 Feb 24;54(5):1123–1133. doi: 10.1007/s43441-020-00129-z

Table 7.

IRB Inspections.

Classification FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 Total
NAI 51% (93) 46% (87) 43% (77) 44% (114) 52% (93) 47% (73) 45% (77) 50% (76) 59% (81) 66% (82) 77% (95) 948 (51%)
VAI 47% (86) 47% (88) 50% (89) 50% (129) 44% (79) 46% (72) 49% (84) 45% (68) 37% (51) 27% (33) 21% (26) 805 (44%)
OAI 2% (4) 7% (13) 7% (13) 6% (15) 4% (7) 7% (11) 6% (10) 5% (8) 4% (6) 6% (7) 2% (3) 97 (5%)
Total 183 188 179 258 179 156 171 152 138 124 124 1850
Warning Letters 6 8 7 14 8 8 5 4 1 4 0 65