Table 4.

Estimated Annual Economic Impact of Terminated Low-Enrolling Studies, Oregon Health & Science University, FY2009

Activity	No. of low- enrolling studies requiring each activity	Cost of activity ($)	Cost of activity for all low-enrolling studies ($)	Total cost ($) (FY2009)
Start-up costs				637,080
Clinical study preparation by study team	97	4,800	465,600
Uncompensated industry clinical study   start-up, budget, and institutional review board   (IRB) preparation	20*	3,250	65,000
Non-industry study IRB full-board review	70	1,023	71,610
Confidential disclosure agreement (CDA)   negotiation	50	125	6,250
Clinical trial agreement (CTA) negotiation	57	400	22,800
Award set-up	97	60	5,820
Maintenance costs				349,875
Continuing IRB reviews	229	130	29,770
Study modifications	1614	195	314,730
CTA amendment negotiation	43	125	5,375
Close-out costs				1,940
Award close-out	97	20	1,940
				Total: 988,895

^*A total of 45 full-board studies in FY2009 used central resources for start-up, budget, and/or IRB preparation and therefore charged non-refundable start-up fees to recoup the costs of these activities regardless of subsequent enrollment.