Table 1.

Descriptive characteristics of the original VALIANT trial[13] and limited VALIANT dataset used in the analysis of protocol departures and documentation queries. Continuous variables are presented as means (standard deviation).

	VALIANT dataset	Study dataset
Number of study sites	931	931
Number of patients	14,703	12,367
Number of patients per site	15.8 (19.1)	13.3 (12.8)
Number of protocol departures	3,934	2,304
Number of protocol departures per subject	0.27 (0.22)	0.19 (0.13)
Number of documentation inconsistencies *	272,998	115,291
Number of documentation inconsistencies * per patient	18.6 (10.5)	9.3 (6.7)
Rate of subject enrollment (per month)	1.4 (1.8)	1.4 (1.8)
Time from trial start date to site initiation (days)	388 (151)	388 (151)

^{^}Protocol departures defined as recorded protocol violations or deviations,

^*documentation inconsistencies defined as case report form queries.