Synopsis
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&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&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Many Q&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
About the Author
2014 Expert Advisory Panel: * Anne Blanchard, Blanchard & Associates (Argentina) * Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt Ltd. (India) * Linda Houle, Linda Houle and Associates (Canada) * Earl Hulihan, EW Hulihan and Associates (USA) * M. Joseph Mardesich, Quality Compliance Consulting, Inc. (USA) * Munish Mehra, PhD, Quantum Biopharma (USA) * Jules Mitchel, PhD, Target Health Inc. (USA) * James Nickas, BioMarin Pharmaceuticals (USA) * Sandra SAM Sather, Clinical Pathways Research (USA) * Teri Stokes, PhD, GXP International (USA) * Dmitry Vorobiev, M.D., Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia) * Beat Wilder, PhD, Widler & Schiemann, (Switzerland)
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