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. Author manuscript; available in PMC: 2012 Nov 1.
Published in final edited form as: Acad Med. 2011 Nov;86(11):1360–1366. doi: 10.1097/ACM.0b013e3182306440

Table 1.

Categories of Unreimbursed Costs Due to Low Enrollment of Clinical Studies, Oregon Health & Science University, FY2009

Categories of cost Explanation Calculations included
Start-up costs
Clinical study preparation by study team Costs associated with study team (excluding the
principal investigator) in preparing industry-
sponsored trials, including study tools, pre-initiation,
and initiation meetings

  • Number of full-board studies

  • Estimated hours of coordination and review

  • Estimated hourly wage for a study coordinator

  • % low-enrolling industry-sponsored trials
Uncompensated industry clinical study
start-up, budget, and institutional review
board (IRB) preparation		 Costs not associated with Clinical Trials Office
(CTO) support or other centralized unit

  • Number of studies that request CTO support

  • Fixed cost per study required by CTO
Non-industry study IRB full-board review IRB costs associated with IRB reviewer’s efforts to
conduct an IRB review and costs to support the
review of a study

  • Number of non-industry studies requiring full-board reviews

  • % non-industry low-enrolling full-board review studies

  • Cost of an IRB review
Confidential disclosure agreement (CDA) negotiation Costs to conduct negotiations with the sponsor for
industry-sponsored clinical studies

  • Number of CDA negotiations

  • Estimated number of hours for negotiations

  • Estimated hourly wage for CTO contracting unit personnel
Clinical trial agreement (CTA) negotiation Costs to conduct negotiations with the sponsor for
industry-sponsored clinical studies

  • Number of CTA negotiations

  • Estimated number of hours for negotiations

  • Estimated hourly wage for CTO contracting unit personnel
Award set-up Costs require to set up study accounts

  • Number of new studies

  • Estimated number of hours to set up a new account

  • Estimated hourly wage for Sponsored Projects Administration (SPA) personnel
Maintenance costs
Continuing IRB reviews Costs associated with preparation of continuing
reviews mandated by regulations

  • Number of continuing reviews

  • Number of hours to prepare continuing reviews per study

  • Estimated hourly wage for a study coordinator

  • % low-enrolling full-board review studies
Study modifications Costs associated with study staff submission of
modifications to a study during the enrollment
period

  • Number of modifications

  • Estimated hours to prepare and review modifications per study

  • Estimated hourly wage for a study coordinator
CTA amendments negotiation Number of amendments of existing agreements that
are processed annually

  • Number of CTA amendments

  • Estimated number of hours to negotiate an amendment

  • Estimated hourly wage for CTO contracting unit personnel
Close-out costs
Award close-out Costs required to close an account at the end of the
study

  • Number of studies closed

  • Estimated number of hours to close an account

  • Estimated hourly wage for SPA personnel