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Expanded and Updated for 2008!

For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals...

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

WHAT'S NEW FOR 2008:

  • 100+ pages of new brand new content, plus hundreds of updated Q&As
  • 80 new Q&As focused on emerging areas of GCP
  • New section on GCP in Latin America
  • Revamped section on Patient Confidentiality/HIPAA in Clinical Trials
  • Focus on emerging concerns regarding who must be listed as "subinvestigators," clinical investigator supervision of clinical trials, off-site patient visits in clinical trials, and increasing resistance of European clinical investigators to sign Form FDA-1572
THE GOOD CLINICAL PRACTICE: A QUESTION & ANSWER REFERENCE GUIDE 2008
Newly updated and expanded for 2008, this industry-leading GCP training and reference guide answers approximately 500 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drugs and biologics.

While continuing with a US/FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, Canada, India, Latin America, Russia and China! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards.

With the completely updated and expanded 2008 guide, read why clinical investigators may have to list clinical research coordinators and other study staff as sub-investigators, why some European regulators (including the Norwegian Medicines Agency) are warning European clinical investigators not to sign the Form FDA-1572, and what citations in FDA compliance letters should tell you about emerging GCP compliance concerns.

In one pocket handbook, 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

  • Now includes a new section on GCP in Latin America!
  • Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!


  • "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

    Shipping May 2008, Approx. 600 pp., 1-882615-86-7

    Call 1-800-856-2556 for Multiple Copy Discounts & Custom Covers!




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    On-Demand GCP Refresher Training 

    Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
    For details on our scenario-based practical GCP application on-demand course, click here.


    GCP for Investigators
     

    Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

    For more details on this scenario-based eGCP program for investigators please click here. 


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    DVD IconWEB SEMINAR ARCHIVE 

     View Catalog of Offerings   

    New Titles added every month! 
    Course Alumni Save 50% 


    Live SeminarLIVE SEMINARS

    Monitoring Clinical Drug Studies: Intermediate 

    Informed Consent Content & Process Requirements for Biobanking Studies 

    Auditing Techniques for Clinical Research Professionals 


    Web SeminarWEB SEMINARS

    10-Week CRA & CRC Beginner Program  

    Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

    Use of Notes to File in Clinical Trial Essential Documentation 

    10-Week Clinical Research Associate (CRA) On-Boarding Program  


    PublicationsPUBLICATIONS

    2012 GCP Question & Answer Guide Print Edition 

    2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

    CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

    CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

    PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)