Table 2.

Workflow Level Personnel Use (Hours)

Initial Submission (Per Study)
Group	Role	Without Standard	Change	With Standard
Single IRB	sIRB Administrator	4.00		4.00
	sIRB Staff	6.00		6.00
Lead Institution Principal Investigator	Lead Institution PI Staff	28.00		28.00
Total		38.00		38.00
Site Addition (Per Site)
Group	Role	Without Standard	Change	With Standard
Single IRB	sIRB Administrator	2.00		2.00
	sIRB Staff	2.00	(1.00)	1.00
Lead Institution Principal Investigator	Lead Institution PI Staff	3.75	(0.50)	3.25
Relying Site Principal Investigator	Relying Site PI Staff	1.75	(0.50	1.25
	Relying Site Administration Staff	6.00	(0.50)	5.50
Total		15.50	(2.50)	13.00
Continuing Review (Per Site and Study Year)
Group	Role	Without Standard	Change	With Standard
Single IRB	sIRB Administrator	4.25		4.25
	sIRB Staff	4.25		4.25
Lead Institution Principal Investigator	Lead Institution PI Staff	4.00	(2.00)	2.00
Relying Site Principal Investigator	Relying Site PI Staff	20.00	(5.00)	15.00
	Relying Site Administration Staff	4.00	(2.00)	2.00
Total		36.50	(9.00)	27.50
Medical and Non-Medical Event Reporting (Per Event)
Group	Role	Without Standard	Change	With Standard
Single IRB	sIRB Administrator	1.00		1.00
	sIRB Staff	3.00		3.00
Lead Institution Principal Investigator	Lead Institution PI Staff	3.00		3.00
Relying Site Principal Investigator	Relying Site PI Staff	4.00		4.00
	Relying Site Administration Staff	1.00		1.00
Total		12.00		12.00