Current Role at Stanford
Director, Clinical Research Quality
Spectrum, Stanford Center for Clinical & Translational Research &Education
Find Regulatory Tools on Spectrum's Researcher Resources page.
Service, Volunteer and Community Work
Board Member, California Poets in the Schools, California Poets in the Schools (2013 - 2015)
San Francisco, California
Cupertino Poet Laureate, City of Cupertino (10/1/2013 - 9/30/2015)
IRB Training Specialist, Stanford University (9/20/2006 - 10/1/2008)
Stanford University, Research Compliance Office
Manager, Regulatory Affairs, Natus Medical, Inc. (1/8/1998 - 2001)
San Carlos, California
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
2014; 62 (5): 797–803
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 PubMedID 24831858