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An Informatics-Based Tool to Assist Researchers in Initiating Research at an Academic Medical Center: Vanderbilt Customized Action Plan

Pulley, Jill M. MBA; Harris, Paul A. PhD; Yarbrough, Tonya RN; Swafford, Jonathan; Edwards, Terri RN; Bernard, Gordon R. MD

Academic Medicine:
doi: 10.1097/ACM.0b013e3181c481bf
Research Issues
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.

Author Information

Ms. Pulley is director of research support services and implementation manager, Vanderbilt Clinical and Translational Science Award, Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee.

Dr. Harris is director, Office of Research Informatics, and operations director of biomedical informatics, VICTR, Vanderbilt University Medical Center, Nashville, Tennessee.

Ms. Yarbrough is research manager, VICTR, Vanderbilt University Medical Center, Nashville, Tennessee.

Mr. Swafford is health systems analyst programmer, Office of Research Informatics, VICTR, Vanderbilt University Medical Center, Nashville, Tennessee.

Ms. Edwards is assistant director, Research Support Services, Vanderbilt University Medical Center, Nashville, Tennessee.

Dr. Bernard is associate vice chancellor for research and principle investigator, CTSA and VICTR, Vanderbilt University Medical Center, Nashville, Tennessee.

Correspondence should be addressed to Ms. Pulley, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, 2525 West End Avenue Sixth Floor, Nashville, TN 37203; telephone: (615) 343-2842; e-mail: Jill.pulley@vanderbilt.edu.

© 2010 Association of American Medical Colleges