Education / Teaching
Textbooks_2022
Oct 7, 2022 by JoAnn Pfeiffera:2:{s:7:"content";s:101343:"
Book Title | Author(s) | Year | Publisher | Course(s) |
Project Management (8th edition) | Larson, E.W. & Gray, C. F. | 2019 | McGraw-Hill | Project Management, Leadership |
An Overview of FDA Regulated Products | Pacifici, E. & Bain, S. | 2018 | Academic Press | Regulatory, Regulations, |
Fundamentals of International Regulatory Affairs, 4th Ed | 2018 | RAPS | International Regulatory Affairs and Regulations | |
Clinical Research Management Complementary Materials | Shah, K.& Pfeiffer, J. | 2021 | LAD Custom Publishers | Conduct of Clinical Research Budgets Contracts Monitoring Clinical Research Operations Research Methods Quality in Research |
A Practical Guide to Managing Clinical Trials | Pfeiffer, J. & Wells, C. | 2017 | CRC Press/Taylor & Frances | Clinical Trial Operations Managing Clinical Trials |
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 |
Managing Clinical Trial Budgets & Contracts | Pfeiffer, J. & Winschiegl | 2016 | LAD Custom Publishers | Contracts Budgets Budgets & Contracts |
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 |
FDA Regulatory Affairs | Pisano, D.J. & Mantus, D. (eds) | 2014 | CRC Press/Taylor & Frances | Regulatory Affairs Fundamentals of New Product Development |
Healthcare Project Management | Macrina, F.L. | 2014 | ASM Press | Clinical Research Ethics and Leadership |
Medical Device Development: Regulation & Law | Kahan, J. | 2014 | Parexel | Medical Device Regulations |
Translational medicine and drug discovery | Littman, B. & Krishna, R. | 2014 | Cambridge University Press | Translational Research |
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 |
Healthcare Project Management | Schwalbe, K. & Furlong, D. | 2013 | Schwalbe Publishing | Project Management |
Introduction to healthcare quality management (2nd Ed) | Spath, P.L. | 2013 | Health Administration Press | Quality |
Transcelerate Training Modules for Risk-Based Monitoring | www.transceleratebiopharmainc.com | 2013 | Quality Monitoring | |
A Pracitcal Guide to Data Management, 3rd Ed | Prokscha, S. | 2012 | Taylor & Frances | Data Management |
Clinical Research and the Law | Tereskerz, P.M. | 2012 | Wiley-Blackwell | Regulatory Affairs |
Principles and practice of clinical research (3rd Ed) | Gallin, J.I. & Ognibene, F.P. (eds) | 2012 | Elsevier | Fundamentals of New Product Development |
Practical Guide to Clinical Date Management (3rd Ed) | Prokscha, S. | 2011 | Taylor & Frances | Data Management |
The Oxford Textbook of Clinical Research Ethics | Emanuel & Christine C. Grady | 2011 | Oxford University Press | Research Ethics |
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 |
Fundamentals of Clinical Trials, 4th Ed. | Friedman, L.M., Furber, C. D. & DeMets, D | 2010 | Springer Publisher | Study Development Ethics |
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 |
New Drug Development: A Regulatory Overview, 8th ed | Mathieu, M. | 2008 | Parexel | Drug Development and Regulations |
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 | |
Introduction to the Responsible Conduct of Research | Steneck, N. | 2007 | http://ori.hhs.gov/education/products/RCRintro/ | Conduct of Clinical Research |
Practical Guides to Quality Management in Clinical Trial Research | Ogg, G. | 2006 | Quality in Research Quality in Clinical Trials | |
Crucial Conversation: Tools for Talking When Stakes Are High | Patterson, K. | 2002 | McGraw-Hill | 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 | |
The Five Dysfunctions of a Team: A Leadership Fable | Lencioni, P. | 2002 | Jossey-Bass | Clinical Research Ethics and Leadership |
Designing Clinical Research (4th Ed) | Hulley, S., Cummings, S., Browner, W., Grady, D. & Newman, T. | 2001 | Lippincott, Williams & Wilkins | Research Methods & Desing |
Medical Device Development: A Regulatory Overview | Kahan, J. | 2000 | Parexel | Medical Devices |
Project Management - The Managerial Process | Larson, E.W. & Gray, C. F. | McGraw-Hill | Project Management | |
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 | |
The Research Methods Knowledge Base (3rd Ed) | Trochim, W. & Donnelly, J. | Atomic Dog | Study Development Ethics | |
Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators (2nd ed.). | Stone, J. | 2010 | Mountainside MD Press | Intro to Clinical Research |
Principles of Biochemistry, 8th Edition | Nelson, D., Cox, M. | 2015 | W.H. Freeman & Company | Biochemistry |
Fundamental Laboratory Approaches for Biochemistry and Biotechnology, 2nd Edition | Ninfa, A.J., Ballou, D.P, & Benore, M. | 2010 | John Wiley & Sons | Biochemistry Lab |
Introductory Statistics, 8th Edition | Mann, P.S. | 2018 | Wiley Publishing | Introduction to Biostatistics |
Clinical Pharmacology Made Ridiculously Simple, 5th Edition | Olson, J. | 2015 | MedMaster Inc | Introduction to Pharmacology |
Basic and Clinical Pharmacology, 14th Edition | Katzung, B. |
Survey for Institutional Members and Students
Aug 15, 2018 by JoAnn PfeifferResearch: Competency Index for Clinical Research Professionals (CICRP): Measuring Competencies of CoAPCR Students
Letter to CoACPR Institutional Members
Good day. There is a team of CoAPCR institutional members who have developed a survey to measure the acquisition of competence and evaluate readiness of students or graduates of academic programs teaching clinical research from our various member institutions. The research study is entitled, "Competency Index for Clinical Research Professionals (CICRP): Measuring Competencies of CoAPCR Students". Jared Kerr, Assistant Professor at the University of North Carolina-Wilmington (UNCW), is serving as the study's Principal Investigator. This research study was approved by the UNCW Institutional Review Board #18-0003. Jared Kerr has been granted access to the CoAPCR institutional member email distribution list. Jared Kerr will use CoAPCR email distribution list to provide each institutional member the survey recruitment materials. The recruitment materials include an email, paper flyer, and web message. The survey is anonymous and personal identifiers of students are not collected in the survey.
We would like CoAPCR institutional members to distribute information about the study using the approved survey recruitment materials to the qualifying student population at your respective institutions. Participation by you and any students is voluntary. Potential study participants will qualify for the study if they are current students or a graduate of an academic program teaching clinical research. You should distribute the survey recruitment materials using your institution's appropriate email distribution list, bulletin board, website, or social media site.
If you do participate in distributing the survey recruitment materials to your students, please let Jared Kerr know the total number of students who qualify to receive the recruitment materials. We need to know when survey recruitment messages are sent to your students and the number of potential survey participants. The number of undeliverable recruitment messages (e.g., email) will be counted, so the total potential number of survey participants is accurate.
Any questions regarding the study or survey including any questions from potential student participants should be directed to Jared Kerr.
Open Survey of CoAPCR Institutional Members
Sincerely,
Principal Investigator:
Jared Kerr, JD, MPH
College of Health and Human Services, University of North Carolina Wilmington
Study Co-Chairs:
Carolynn Jones, DNP, MSPH, RN
Carlton Hornung, PhD, MPH
Consortium of Academic Programs in Clinical Research (CoAPCR)
Survey Invitation to Students of Academic Programs in Clinical Research
Students or graduates of academic program teaching clinical research, please take a few minutes to complete an anonymous survey. This research study was approved by the UNCW Institutional Review Board #18-0003. Researchers need your help to measure the utility of a new competency index called the Competency Index for Clinical Research Professionals (CICRP). The CICRP aims to estimate perceptions of confidence and readiness in clinical research competencies.
CTSA Program Good Clinical Practice Standards
Feb 23, 2017 by JoAnn PfeifferCTSA Program Good Clinical Practice Standards Published (National Center for Advancing Translational Sciences (NCATS), February 23, 2017)
Investigators from the Clinical and Translational Science Awards (CTSA) Program hubs recently published three articles in the Journal of Clinical and Translational Science describe the three phases of Good Clinical Practices (GCP). Education, training, standards, competencies, and best practices are discussed across the three papers. CoACPR members, Nancy Calvin-Naylor and Carolynn Jones. The articles are available from the journal and NCATS websites.