This industry-leading GCP reference guide answers over 1,000 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 2016 guide includes: Over 15 new contributing domestic authors with targeted expertise in QA, Monitoring, Compliance, Site Management and several other core GCP areas. * Dozens of new Q&amp;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. * 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. * 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.

Good Clinical Practice: A Question & Answer Reference Guide, May 2016

Earl W. Hulihan

Reference

Parexel Intl Corp

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 2017 guide includes: * Updates focused specifically on the revision of ICH GCP (E6 R2) and the impact on clinical trial processes and systems. * Over 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, TMF, Data Management and many other core GCP areas. * Dozens of new Q&amp;As, including in-depth analysis from distinguished international GCP expectations, including risk-based monitoring, electronic informed consents, eSource, TMF readiness and others. * Newly-added chapters on clinical data management and the TMF. * 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. * 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. * 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.

Good Clinical Practice: A Question & Answer Reference Guide, May 2017

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&amp;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!

Good Clinical Practice: A Question & Answer Reference Guide, May 2018

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

See the best price to sell, buy, or rent books by Earl W. Hulihan. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Earl W. Hulihan

See the best price to sell, buy, or rent books by Earl W. Hulihan. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Good Clinical Practice: A Question & Answer Reference Guide, May 2016

Good Clinical Practice: A Question & Answer Reference Guide, May 2017

Good Clinical Practice: A Question & Answer Reference Guide, May 2018

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