Good Clinical Practice: A Question & Answer Reference Guide 2020/2021 - Softcover

Earl W. Hulihan

Softcover

ISBN 10: 0996346287 ISBN 13: 9780996346283

Publisher: Parexel Intl Corp, 2020

Synopsis

This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2020/2021 guide includes: * Continued updates focused on the impact of changes to ICH GCP E6 R2, enforcement of the revisions and its impact on clinical trial processes and systems, including Quality-by-Design and Risk-Based Quality Management (QM) expectations. * Changes resulting from the implementation of the Common Rule including changes in informed consent requirements, the impact of Annex 13 on investigational product management. * Impact of GDPR on eTMF management and common TMF regulatory findings. * Dozens of new Q&As including changes resulting from COVID-19. * New questions focused specifically on how Risk-based Quality Management (Section 5 of the Addendum) impacts monitoring activities. * Updates on the EU's General Data Protection Regulation (GDPR) regulation and the MHRA 2018 Data Integrity Guidance. * Coverage on updates to the "Common Rule" and NIH updates for clinical trials research. * Questions focused specifically on how Risk-Based Quality Management (Section 5 of the Addendum) impacts monitoring activities. * Updates to state- and country-specific regulations including the U.S., Brazil, Argentina, Peru, India and many others. * Over 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, the Trial Master File, Data Management and many other core clinical research areas. * Extensive graphs and charts on the latest inspection trends and findings!

About this title

About the Author

Editor-in-Chief: Professor Earl W. Hulihan, President, Professor Earl W. Hulihan Consultancy; Editor Emeritus: Mark Mathieu, PAREXEL International Corporation. Expert Advisory Panel: Anne Blanchard, Blanchard & Associates, LLC (Latin America); Nikki Christison, B.S., TIACR, CCRA, Clinical Resolutions (USA); Tony C. Cruz, InClin, Inc. (USA) Donna W. Dorozinsky, RN, MSN, CCRC, Just In Time GCP (USA) Lourdes M. Frau MD FAAP FISPE (USA); George Gasparis, The PEER Consulting Group (USA); Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt. Ltd. (India); Jerold Grupp, CFR Health (USA); Jonathan Heinemann, BioMarin Pharmaceuticals (USA); Linda Houle, Linda Houle and Associates (Canada); Xiaoshun Hong, Professor and Deputy Director of Information Center, ; China Food and Drug Administration (China); Professor Earl W. Hulihan, Professor Earl W. Hulihan Consultancy; Rutgers Medical School USA), China ; Pharmaceutical University (Nanjing); Allan Johansen, a3GCP Consulting (Australia and New Zealand); Nelson Kopyt D.O., FACP, FASN, CPI, Lehigh Valley Hospital; Morsani College of Medicine; ; Northeast Clinical Research Center (USA); Susan M. Leister, MBA, PhD, CQA, CSSBB (USA); Daniel Liu, PhD, Chief Scientific Officer, Beijing Clinical Service Center (China); Joanne S. Malia, MS, MS, Independent GCP Consultant (USA); Joyce Elaine Marinho, CCRP, COO, Blanchard & Associates, LLC (Latin America); Munish Mehra, PhD, Tigermed (USA); Mary Mills, RN, CCRA, Mary Mills and Associates, LLC (USA); David Pfennig, MS, MBA, P-Square, LLC (USA); Denise G. Redkar-Brown, MT., Independent Consultant (USA); Christopher Rush, MBA, FDA Quality + Regulatory Consultants, LLC (USA); Sandra SAM Sather, BSN, CCRA, CCRC, Clinical Pathways Research LLC (USA); Chana Sternberg, Chana Sternberg Consultancy, Ltd. (Israel); Teri Stokes, Ph.D., Cytel Inc. Clinical Research Services (USA); Dmitry Vorobiev, MD, Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia); Beat Wilder, PhD, Widler & Schiemann, (Switzerland).

Edition details

• Publisher: Parexel Intl Corp
• Publication date: 2020
• Language: English
• ISBN 10: 0996346287
• ISBN 13: 9780996346283
• Binding: Spiral-bound
• Number of pages: 744
• Editor: Earl W. Hulihan