Academic Program Textbook List

Book Title Author(s) Year Publisher Course(s)
A Clinical Trial Workbook: Material to Complement Research Education & Training Programs (2nd Ed) Shah, K., Wells, C., & Pfeiffer, J. 2017 LAD Custom Publishers Conduct of Clinical Research                       Budgets                             Contracts                        Monitoring                   Clinical Research Operations                   Research Methods        Quality in Research
A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim (2nd Ed) Liu, M.B. & Davis, K. 2010 Wiley-Blackwell Intro to Clinical Research
A Guide to Project Management (5th Ed) Project Management Institute 2013 Project Management
A Practical Guide to Managing Clinical Trials Pfeiffer, J. & Wells, C. 2017 CRC Press/Taylor & Frances Clinical Trial Operations Managing Clinical Trials
Business Administration for Clinical Trials: Managing Research Strategy, finance, regulation and quality Cavilieri, R.J. & Rupp, M.E. 2015 Sigma Theta Tau Study and Site Management
Clinical Research and the Law Tereskerz, P.M. 2012 Wiley-Blackwell Regulatory Affairs
Clinical Research Manual: Practical tools and template for managing clinical research Cavilieri, R.J. & Rupp, M.E. 2013 Sigma Theta Tau Study and Site Management
CRA’s Guide to Monitoring Clinical Research (4th Ed) Weeks-Rowe, E., Woodin, K. & Schneider, J. 2016 CenterWatch Managing Clinical Trials Monitoring Clinical Trials                                  Study & Site Management
Crucial Conversation: Tools for Talking When Stakes Are High Patterson, K. 2002 McGraw-Hill Clinical Research Ethics and Leadership
Designing Clinical Research (4th Ed) Hulley, S., Cummings, S., Browner, W., Grady, D. & Newman, T. Study Development    Ethics
Drugs: From Discovery to Approval (2nd Ed) Ng, Rick Regulatory Affairs
Evaluating the Science and Ethics of Research on Humans: A guide for IRB Members Mazur, D.J. 2007 IRBs and Research          Scientific and Research Review Boards
FDA Regulatory Affairs Pisano, D.J. & Mantus, D. (eds) 2014 CRC Press/Taylor & Frances Regulatory Affairs        Fundamentals of New Product Development
Fundamentals of Clinical Trials, 4th Ed. Friedman, L.M., Furber, C. D. & DeMets, D 2010 Springer Publisher Study Development    Ethics
Healthcare Project Management Schwalbe, K. & Furlong, D. 2013 Schwalbe Publishing Project Management
Healthcare Project Management Macrina, F.L. 2014 ASM Press Clinical Research Ethics and Leadership
Integrity in Research: Creating an Environment that Promotes the Responsible Conduct of Research Committee on Assessing Integrity in Research Environments, National Research Council, Institute of Medicine 2002 Conduct of Clinical Research
Introduction to healthcare quality management (2nd Ed) Spath, P.L. 2013 Health Administration Press Quality
Managing Clinical Trial Budgets & Contracts Pfeiffer, J. & Winschiegl 2016 LAD Custom Publishers Contracts                           Budgets                             Budgets & Contracts
New Drug Development: A Regulatory Overview Mathieu, M. 2008 Parexel Drug Development and Regulations
ORI Introduction to the Responsible Conduct of Research Steneck, N. 2007 http://ori.hhs.gov/education/products/RCRintro/ Conduct of Clinical Research
Practical Guide to Clinical Date Management (3rd Ed) Prokscha, S. 2011 Taylor & Frances Data Management
Practical Guides to Quality Management in Clinical Trial Research Ogg, G. 2006 Quality in Research      Quality in Clinical Trials
Principles and practice of clinical research (3rd Ed) Gallin, J.I. &  Ognibene, F.P. (eds) 2012 Elsevier Fundamentals of New Product Development
Project Management – The Managerial Process Larson, E.W. & Gray, C. F. McGraw-Hill Project Management
Responsible Conduct of Research Shamoo, A.E. & Resnick, D.B. 2015 Oxford University Press Clinical Research Ethics and Leadership
Safety and Evaluation in the Development of Medical Devices and Combination Products (3rd Ed) Gad, C. & McCord, M.G. CRC Press/Taylor & Frances Medical Devices
Strengths Based Leadership: Great Leaders, Teams, and Why People Follow Rath, T. & Conchie, B. 2009 Gallup Press Clinical Research Ethics and Leadership
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs & Biologics Wood, L.F. &  Foote, M. 2009 Springer Publisher Regulatory Writing      Fundamental of New Product Development
The Five Dysfunctions of a Team: A Leadership Fable Lencioni, P. 2002 Jossey-Bass Clinical Research Ethics and Leadership
The Oxford Textbook of Clinical Research Ethics Emanuel & Christine C. Grady 2011 Research Ethics
The Research Methods Knowledge Base (3rd Ed) Trochim, W. & Donnelly, J. Atomic Dog Study Development    Ethics
Transcelerate Training Modules for Risk-Based Monitoring www.transceleratebiopharmainc.com 2013 Quality                               Monitoring
Translational medicine and drug discovery Littman, B. & Krishna, R. 2014 Cambridge University Press Translational Research