Featuring An All-New Index of Topics! This industry-leading GCP training and 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. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: * Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. * Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. * Updated information on electronic records and use of EMR in clinical research. * 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. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US. * Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. 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. 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

Good Clinical Practice: A Question & Answer Reference Guide, May 2013

Michael Hamrell

Reference

Parexel Intl Corp

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 2014 guide includes: In-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials and updated information on the role and responsibilities of IRBs. * Revisions and updates to the section on HIPAA and privacy. * Updated information on electronic records and use of EMRs in clinical research. * 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. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Many Q&amp;As added regarding clinical trials and GCP for medical devices. * Updates to information on Latin America, India, Russia, Ukraine, Canada, and China, and the addition of GCP compliance and clinical trial requirements for Australia, New Zealand, and Israel. * Insights into how the FDA is focusing more intently on sponsors quality systems and risk-based approaches, especially when significant problems are discovered at the clinical study site, why significant non-compliance is still being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. * *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. 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

Good Clinical Practice: A Question & Answer Reference Guide, May 2014

Barnett International's 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 2015 guide includes: In-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials and updated information on the role and responsibilities of IRBs. * Revisions and updates to the section on HIPAA and privacy. * Updated information on electronic records and use of EMRs in clinical research. * 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. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Many Q&amp;As added regarding clinical trials and GCP for medical devices. * Updates to information on Latin America, India, Russia, Canada, and China, as well as GCP compliance and clinical trial requirements for Australia, New Zealand, and Israel. * Insights into how the FDA is focusing more intently on sponsors quality systems and risk-based approaches, especially when significant problems are discovered at the clinical study site, why significant non-compliance is still being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. * *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. 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

Good Clinical Practice: A Question & Answer Reference Guide, May 2015

Barnett International

Newly updated and expanded for 2012, this industry-leading GCP training and reference guide answers approximately 800 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for drugs and biologics. While continuing with a U.S./FDA focus, this innovative reference 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, India, Latin America and Russia! 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 2012 guide, there are 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; 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments; Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US, such as Canada, Latin America, India, and Eastern Europe. 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! New in 2011: Need-to-know information related to the March 2011 updated version of the FDA s compliance policy guide manual (CPGM) 7348.810, which reveals the agency s goals and specific procedures for FDA field investigators in conducting, sponsor/monitor/CRO inspections. 60+ pages of all-new Q&amp;As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments.

Good Clinical Practice: A Question & Answer Reference Guide, May 2012

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

Books by Michael Hamrell

See the best price to sell, buy, or rent books by Michael Hamrell. 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 2013

Good Clinical Practice: A Question & Answer Reference Guide, May 2014

Good Clinical Practice: A Question & Answer Reference Guide, May 2015

Good Clinical Practice: A Question & Answer Reference Guide, May 2012