Table 5.

Frequency of VTs in Clinical Investigator Warning Letters.

VT#	Violation Theme	CDER n = 98	CDRH n = 56	CBER n = 10	Total n = 164	P value
1	Deviation from investigational plan	93 (95%)	52 (93%)	9 (90%)	154 (94%)	0.5493
2	Failure to maintain adequate/accurate source documentation	61 (62%)	39 (70%)	8 (80%)	108 (66%)	0.4161
3	Informed consent	36 (37%)	33 (59%)	6 (60%)	75 (46%)	0.0184
4	Violations related to investigational product	32 (33%)	13 (23%)	4 (40%)	49 (30%)	0.3497
5	Failure to personally supervise the study	22 (22%)	4 (7%)	0	26 (16%)	0.0191
6	Failure to protect subject safety/report adverse events to IRBs/communicate with the IRB	31 (32%)	19 (34%)	3 (30%)	53 (32%)	0.9616
7	Submission of false information to the FDA and sponsor	1 (1%)	0	0	1 (1%)	1.0000
8	Failure to communicate with the sponsor	3 (3%)	1 (2%)	0	4 (2%)	1.0000
9	Financial disclosure	0	1 (2%)	0	1 (1%)	0.4024