This course provides the basic concepts of what clinical research is, how it is carried out and by whom, and its underlying ethical and regulatory framework. It discusses the key principles of Good Clinical Practice such as data management and the protection of human subjects. It further explores specific issues in clinical research, including protocol design, critical regulations and oversight bodies, common types of clinical trials, regulatory compliance, and clinical research billing.
This course provides an overview of the clinical research enterprise and its parts. It serves as a great supplement to other CITI Program courses in Human Subjects Research (HSR) and Good Clinical Practice (GCP).
Clinical Billing Professionals, Clinical Data Managers, Clinical Research Coordinators, Compliance Officers, Contract Research Organizations (CROs), Faculty and Post-Docs, IRB Administrators, IRB Members, Legal and Risk Management Staff, Research Administrators, Researchers, Sponsors, Students
Meet the Authors
Quincy Byrdsong, EdD, CIP, CCRP – Lipscomb University
Dr. Byrdsong is the Vice Provost for Health Affairs at Lipscomb University where he has operational responsibility for Lipscomb Health. He holds a Doctor of Education in Curriculum Development, is a Certified IRB Professional, and a Certified Clinical Research Professional. Dr. Byrdsong is a Past President of SOCRA and serves on the Board of Directors for AAHRPP.
Melissa Byrn, MA, MS – Polsky Center for Entrepreneurship and Innovation, University of Chicago
Melissa Byrn is the Director of Innovation Programs at the University of Chicago Polsky Center for Entrepreneurship and Innovation where she leads science and technology venture programming strategy. Melissa has held leadership roles in clinical trial operations and regulatory compliance at the University of Chicago and the University of Pennsylvania.
Marie Jackson, PhD, MBA – Methodist le Bonheur Healthcare
Inspired by the possibility of being part of medical discoveries, Dr. Jackson’s thirty-year clinical research journey includes stops at University of Pittsburgh, Emory University, Harbor-UCLA, City of Hope, Amgen, Allergan, and most recently Methodist Le Bonheur Healthcare in Memphis where she oversees all research activities for the health system.
Dawn N.L. Pittinger, MBA CHRC, CRCP – Moffitt Cancer Center
Dawn Pittinger has more than 13 years of experience in clinical research and is currently part of Moffitt Cancer Center’s Corporate Research Compliance Team. She holds an MBA in Healthcare Administration, is Certified in Healthcare Research Compliance, a certified Clinical Research Contract Professional, and currently working on her Doctorate of Business Administration.
Kris West, JD, MS – Council on Governmental Relations (COGR)
Kris West is the Director for Research Compliance and Ethics at COGR, an association of research intensive institutions. She previously worked as Emory University’s Chief Compliance Officer providing guidance to the IRB, IACUC, and other research compliance units. She is an attorney and has a M.S. in drug regulatory affairs.
Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP – Kelly Willenberg & Associates
Dr. Kelly Willenberg is the owner of a healthcare research compliance company. She is a frequent speaker on healthcare compliance issues, grief, loss, and process improvement. She serves on the Board of Directors for Health Care Compliance Association. Listen to Kelly on her podcast series #kellytothecore.