title: Observational study of contracts processing at 29 CTSA sites.
abstract: We measured contracts final negotiation (FN) and full execution (FE) times using shared definitions in a prospective observational study of management of contracts for clinical trials at 29 CTSA institutions. Median FN and FE times were reached in 39 and 91 days, respectively; mean times for FN and FE were 55 and 103 days, respectively. Individual site medians ranged from 3 to 116 days for FN and 34 to 197 days for FE. The use of master agreements (MAs) and previously negotiated terms (PNTs) was associated with significant reduction of FN times by a mean of 33 days (p < 0) and 22 days (p < 0.001), respectively. PNTs, but not MAs, were associated with significantly reduced FE time (22 days, p < 0.007). Gap analysis revealed a gap of 22 days between contracts negotiation and Institutional Review Board (IRB) review and intervals of 33 days (contracts) and 48 days (IRB review) during which the process steps were being conducted alone, suggesting a potential benefit with parallel processing. These baseline data support a plan to investigate root causes of prolonged study start-up time by examining causes of variation and outliers.
authors.affiliation: Industry Contracts, University of California, San Francisco, California, USA.
authors.forename: James
authors.initials: J
authors.lastname: Kiriakis
authors.forename: Nicholas
authors.initials: N
authors.lastname: Gaich
authors.forename: S Claiborne
authors.initials: SC
authors.lastname: Johnston
authors.forename: Darlene
authors.initials: D
authors.lastname: Kitterman
authors.forename: Daniel
authors.initials: D
authors.lastname: Rosenblum
authors.forename: Libby
authors.initials: L
authors.lastname: Salberg
authors.forename: Adam
authors.initials: A
authors.lastname: Rifkind
mesh_terms: D032982:Contracts; D028744:Ethics Committees, Research; D017008:Negotiating; D013997:Time Factors; D057170:Translational Research, Biomedical
keywords: CTSA Consortium; clinical research management; clinical trials; contracts; public private partnerships; virtual national laboratory
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