This one-day course will be offered via Zoom only. Attendance is required as it will not be recorded. Course schedule will be 9:00am – 4:00pm, with a 1-hour lunch and (3) 10-minute breaks.

There is a substantial gap between the development of innovations in medicine, public health, education, and other fields and their delivery in hospitals, communities, and schools. Implementation science is an emerging field that is dedicated to the study of closing this gap by scientifically identifying the factors that facilitate and impede the systematic uptake of knowledge and evidence. It includes the study of how individual, organizational and environmental behavior impact implementation effectiveness, and how to develop and test strategies to change these behaviors. This course will provide an overview of the core theories and methods in implementation research and practice. Students will have opportunities to apply these principles through a case study.

Learning Objectives:
- Define implementation science
- Describe how implementation science connects to allied fields such as quality improvement and design thinking
- Define implementation outcomes are how they are connected to and different from health outcomes
- Describe key implementation models, theories, and frameworks, their application in various settings, and how they can be used to guide implementation efforts
- Identify individual, organizational, and systems-level determinants affecting the quality of implementation
- Understand how to develop effective strategies for sustainable and scalable implementation
- Describe the most common research designs and evaluation approaches in implementation science

Instructor: Rohit Ramaswamy, PhD, MPH
Rohit Ramaswamy, PhD, MPH, is a Professor of Pediatrics at the James M. Anderson Center for Health Systems Excellence. Prior to joining Cincinnati Children’s, he was the Associate Director of the Public Health Leadership Program and a Professor in Maternal and Child Health at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill.

Ramaswamy’s area of expertise is in Implementation and Improvement science, which deals with the development and evaluation of systematic methods and tools to sustainably implement and improve complex interventions. His work blends the tools of systems science, design thinking, implementation science and continuous quality improvement to build capacity for implementation. His global projects include the improvement of clinical and operational processes in tertiary maternity hospitals in Ghana, integrating mental health service delivery into the district primary health care system in India. He has developed and taught Implementation Science programs in South Africa and in Zambia. In the US, he has led the development of innovative methods to evaluate complex community transformation initiatives.

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Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational Device Exemptions (IDEs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IDE Workshop.

This workshop will:

• Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
• Provide guidance on when the IDE regulations apply and discuss possible exemptions
• Review significant risk and non-significant risk device studies
• Discuss the preparation, submission, and maintenance of IDE applications
• Encourage participant discussion of case scenarios

Speakers: Kylie Opel, JD and David Jensen, PhD, RAC

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NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IND workshop February 10

The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:

Michael Gibson, MS, MD
Professor of Medicine, Harvard
Interventional Cardiologist, BI Lahey
CEO & President, Baim Institute for Clinical Research & PERFUSE Study Group

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