Good Clinical Practice: A Question & Answer Reference Guide, May 2018
Description:
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 2018 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. * Dozens of new Q&As including FDA s guidance on R2 implementation, status of the EU Directive update, and changes to US FDA Compliance Program Guidance Manual 7348.10. * Updates on the EU s new General Data Protection Regulation (GDPR) and the MHRA 2018 Data Integrity Guidance. * Coverage on updates to the Common Rule and NIH updates for clinical trials research. * New 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 US, 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. * Plus extensive graphs and charts on latest inspection trends and findings!
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