Table 2.

Description of randomized groups

	On-site	No on-site
No. sites	99	97
No. of participants	2107	2264
Local monitoring
No. participants with ≥ 1 review (%)	1867 (88.6)	2026 (89.5)
Total participant chart reviews	5113	5133
On-site monitoring
No. monitoring visits	469
No. participants with ≥ 1 review (%)	1930 (91.6)
Total participant chart reviews	5345
Visit Cost Summary form received (%)	98.0
- Person-hours preparing for visit	2,328
- Person-hours conducting on-site visit	9,515
- Person-hours writing report	2,670
- Person-hours resolving issues post-visit	2,086