Bio

Current Role at Stanford


Manager, Regulatory Services and Education
Spectrum, Stanford Center for Clinical and Translational Education and Research
Spectrum Operations, Training and Compliance (OTC)

Service, Volunteer and Community Work


  • Board Member, California Poets in the Schools, California Poets in the Schools (March 18, 2013 - Present)

    Location

    San Francisco, California

  • Cupertino Poet Laureate, City of Cupertino (10/1/2013 - 9/30/2015)

    Location

    Cupertino, California

Publications

All Publications


  • Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program. Journal of investigative medicine : the official publication of the American Federation for Clinical Research Holbein, M. E., Berglund, J. P., O'Reilly, E. K., Hartman, K., Speicher, L. A., Adamo, J. E., O'Riordan, G., Brown, J. S., Schuff, K. G. 2014; 62 (5): 797-803

    Abstract

    The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role.The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation.The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

    View details for DOI 10.231/JIM.0000000000000083

    View details for PubMedID 24831858

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