title: An informatics-based tool to assist researchers in initiating research at an academic medical center: Vanderbilt Customized Action Plan.
abstract: The regulatory review and approval process is a significant part of the workflow associated with initiating clinical and translational research projects. Ambiguity concerning submission requirements and expected times associated with the review process can create additional work for research teams and ultimately delay important scientific projects. In an effort to provide assistance to investigators, we have developed an online interactive interface which elicits basic study characteristics for a single project and subsequently produces a list of required administrative applications needed for approval along with clear instructions concerning expectations from the research team. This system, the Vanderbilt Customized Action Plan (V-CAP), was launched in October 2006 and has been well received by researchers. In this article, the authors present (1) the V-CAP project design, (2) a reference workflow associated with Vanderbilt policies and regulations, (3) the V-CAP metrics of use by Vanderbilt research teams, and (4) a list of recommendations for other academic centers considering a similar systems-based approach for helping researchers efficiently navigate processes related to regulatory approval. The informatics-systems-based approach of the V-CAP is scalable to other academic medical centers and may serve as a useful model to help researchers navigate the complexity of the regulatory approvals process.
authors.affiliation: Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee 37203, USA. Jill.pulley@vanderbilt.edu
authors.forename: Jill M
authors.initials: JM
authors.lastname: Pulley
authors.forename: Paul A
authors.initials: PA
authors.lastname: Harris
authors.forename: Tonya
authors.initials: T
authors.lastname: Yarbrough
authors.forename: Jonathan
authors.initials: J
authors.lastname: Swafford
authors.forename: Terri
authors.initials: T
authors.lastname: Edwards
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Bernard
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence* / Q000592:standards; D033161:Government Regulation; D006784:Hospitals, Teaching; D006801:Humans; D008490:Medical Informatics / Q000458:organization & administration*; D016730:Program Development; D012108:Research Personnel; D013714:Tennessee; D057170:Translational Research, Biomedical; D014481:United States; D014486:United States Food and Drug Administration