HCCA would like to thank all who helped produce this book.
Lead Editor
Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, Owner, Kelly Willenberg & Associates, Chesnee, SC
Authors
Marti Arvin, JD, CCEP-F, CHC-F, CHPC, CHRC, Vice President, Audit Strategy, CynergisTek, Austin, TX
Tammie Bain, BS, JD, Assistant Director, Industry Contracts, Emory University, Office of Technology Transfer, Atlanta, GA
L. Steven Brown, MS, CPH, Biostatistician, Parkland Health and Hospital System, Dallas, TX
Draco Forte, MEd, CHRC, Director, Ankura Consulting, Chicago, IL
Stuart Horowitz, PhD, MBA, President, Institutions and Institutional Services, WIRB-Copernicus Group, Princeton, NJ
Daniel Kavenaugh, Ph.D., Senior Scientific Advisor, Gene Therapy, WIRB-Copernicus Group, Princeton, NJ
Carole Klove, RN, JD, General Counsel / Chief Nursing Office, Elemeno Health, San Francisco, CA
Heather Kopeck, CHRC, Director of Development Policy and Advancement Relations, University of California, Office of the President, Oakland, CA
Darshan Kulkarni, Pharm.D, MS, Esq., Vice President of Regulatory Strategy and Policy, Synchrogenix, Philadelphia, PA
Jennifer Laporte, MPA, CRA, Sponsored Programs Manager, Morgridge Institute for Research, Madison, WI
Scott J. Lipkin, DPM, CIP, Managing Director, Ankura Consulting, Orlando, FL
Ryan Meade, JD, CHC-F, Senior Managing Director, Ankura Consulting, Chicago, IL
F. Lisa Murtha, JD, CHC, CHRC, Senior Managing Director, Ankura Consulting, Philadelphia, PA
Susan Partridge, BSN, MBA, CCRC, Vice President, Research Administration, Parkland Health and Hospital System, Dallas, TX
Kelé Piper, MS, CIP, CHRC, Director, Research Compliance, Beth Israel Deaconess Medical Center, Boston, MA
Kathleen Price, RN, MBA, CIP,Director, Office of Human Subjects’ Protection, St. Jude Children’s Research Hospital, Memphis, TN
Wendy Schroeder, BSN, RN, CCRC, Director of Research and Regulatory Programs, VisionGate, Inc., Seattle, WA
Juliann Tenney, JD, CHRC, Chief Privacy Officer, University of North Carolina, Chapel Hill, NC
Debbie Troklus, CCEP-F, CHC-F, CCEP-I, CHPC, CHRC, Senior Managing Director, Ankura Consulting, Louisville, KY
Sheryl Vacca, CHC-F, CCEP-F, CCEP-I, CHPC, CHRC, Senior Vice President, Chief Risk Officer, Providence St Joseph Health, Providence, RI
Nicole Visyak, MS, MA, CCRC, Director, Ankura Consulting, Boston, MA
David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance and Integrity, HCA Healthcare, Nashville, TN
Kristin West, CHRC, JD, MS, Chief Compliance Officer, Emory University, Atlanta, GA