title: Retooling institutional support infrastructure for clinical research.
abstract: Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a similar transition.
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States. Electronic address: denise.snyder@duke.edu.
authors.forename: Denise C
authors.initials: DC
authors.lastname: Snyder
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Rebecca N
authors.initials: RN
authors.lastname: Brouwer
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Cory L
authors.initials: CL
authors.lastname: Ennis
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Lindsey L
authors.initials: LL
authors.lastname: Spangler
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Terry L
authors.initials: TL
authors.lastname: Ainsworth
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Budinger
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Catherine
authors.initials: C
authors.lastname: Mullen
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hawley
authors.affiliation: Duke Clinical Research Institute, 300 West Morgan Street, Durham, NC 27701, United States.
authors.forename: Gina
authors.initials: G
authors.lastname: Uhlenbrauck
authors.affiliation: Duke University School of Medicine, 2424 Erwin Road, Durham, NC 27710, United States.
authors.forename: Mark
authors.initials: M
authors.lastname: Stacy
mesh_terms: D000046:Academic Medical Centers / Q000458:organization & administration*; D035843:Biomedical Research / Q000458:organization & administration*; D028744:Ethics Committees, Research; D006801:Humans; D013192:Staff Development
keywords: Academic medical center; Clinical research; Research administration