Emily Ouellette, QI Program Assistant Director, FDA and Regulatory Support, is responsible for developing and implementing activities that support FDA regulated trials, including Sponsor-Investigators and requirements for clinical trials registration and disclosure. In this capacity, she leads the mandatory not for cause Sponsor-Investigator audit program and provides training and guidance to investigators holding investigational product applications from the FDA (IND/IDE). Additionally she provides guidance and support to the Partners research community in the area of clinical trials registration and disclosure. Before joining the QI Program as a QI Specialist in 2011, Emily worked at The Center for Information and Study on Clinical Research Participation (CISCRP) as Senior Project Manager where she was responsible for project management and oversight of regulatory matters affecting clinical trials. Emily is a graduate of Colby College and the University of Pittsburgh School of Law where she was a member of the Journal of Environmental and Public Health Law. She is admitted to the Bar in MA and ME.