Good Clinical Practice: A Q&A Reference Guide (2015) Hard Copy

Barnett International Publication
2015 GCP Guide  

This industry-leading GCP reference guide answers over 1,200 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2015 guide includes:  

  • Over 100 new Q&As, including in-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements.   
  • New questions and answers related to GCP expectations, including risk-based monitoring, electronic informed consent and records, social media, HIPAA, and the role and responsibilities of IRBs.  
  • Completely updated sections featuring all the latest data and trends on the FDA and EMA’s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.  
  • Latest updates and information on the TransCelerate initiatives to re-engineer the clinical trial process  
  • Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices.   
  • Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia.  
  • Details on the upcoming changes to the Clinical Trial Directives from EMA for clinical trials in European Union   
  • Insights into FDA’s focus on sponsors’ quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.  

Read how the FDA is focusing more intently on sponsors’ quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues.      

About Barnett’s GCP Q&A Guide: At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are 'best practices' derived from regulations, guidances, and industry standards and practices and not all found in black and white in the regulations. Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries. In Barnett’s comprehensive guide, you'll have authoritative answers to hundreds of common and emerging questions in 20+ GCP-related areas, right at your fingertips:

  • FDA and ICH GCP Standards for Clinical Research    
  • Form FDA 1572-Statement of Investigator    
  • Informed Consent    
  • Patient Recruitment    
  • State Standards and GCP    
  • Source Data/Documentation    
  • Investigator/Site Requirements    
  • Clinical Monitoring    
  • Clinical Study Safety Reporting    
  • Clinical Trial Protocols/Protocol Changes/Protocol Violations    
  • Institutional Review Boards    
  • Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling    

2015 Expert Advisory Panel:

  • Anne Blanchard, Blanchard & Associates, LLC (Latin America)
  • Paula Valeria Casasco, PiCRIS LLC (Latin America)
  • Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt Ltd. (India)
  • Linda Houle, Linda Houle and Associates (Canada)
  • Xiaoshun Hong, Professor and Deputy Director of Information Center, China Food and Drug Administration (China)
  • Earl Hulihan, Earl W. Hulihan Consultancy, LLC (USA)
  • Allan Johansen, a3GCP Consulting (Australia and New Zealand)
  • Daniel Liu, PhD, Chief Scientific Officer, Beijing Clinical Service Center (China)
  • Joyce Elaine Marinho, CCRP, COO, Blanchard & Associates, LLC (Latin America)
  • Munish Mehra, PhD, Tigermed (USA)
  • Sandra “SAM” Sather, Clinical Pathways Research (USA)
  • Chana Sternberg, Chana Sternberg Consultancy, Ltd. (Israel)
  • Teri Stokes, PhD, GXP International (USA)
  • Dmitry Vorobiev, MD, Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia)
  • Beat Wilder, PhD, Widler & Schiemann, (Switzerland)  

Custom cover and group bulk order discounts available! Call 1-800-856-2556 for more information.     

 Now Available in Electronic Format!            

  • Fully searchable by keyword     
  • Active links internally and externally     
  • Bulk pricing and custom covers available    

Reader Testimonials:   

'This book should be mandatory reading for every person involved in clinical research.'Munish Mehra, Ph.D., Managing Director, Global Drug Development Experts   

'Unless you already know everything there is to know about GCP, we recommend that you buy this book. This book is excellent.'Graeme Scott, Anjo Strik, and Jean Saint-Pierre in The Quality Assurance Journal   

'The book is the most important advance in clinical research education in quite some time... A valuable tool that I recommend every clinical research professional have on their desk.'Lisa Zimmerman, MS, Director of QA and Regulatory Compliance, Duke Clinical Research Institute   

'This book is already a leader among GCP references and one that offers an immediate return for readers.'William Hirschhorn, Drexel University College of Medicine