Visit www.brookwood-global.com for further details and to order online • OUR E-BOOKS • GCLP Regs RM MD NIS CDM PV GDPR GCP 15 Golden IND/GCP Rules for Investigators This quick and easy to read, illustrated, bulletpoint guide breaks down IND requirements and ICH GCP into 15 digestible and bite-size chunks, the ‘golden rules’. It will help investigator site personnel comply with ICH GCP investigator responsibilities and the US Code of Federal Regulations 21 CFR Part 312, which applies to all studies performed in accordance with a US Investigational New Drug Application (IND). Author: Prof Dr David Hutchinson ISBN: 978-1-912055-73-9 Price Band: D 10 Golden GCP Rules for Pharmacists This book aims to help the trial pharmacist understand the GCP requirements relevant to handling study medications in a clinical trial. Following the 10 basic rules described here will facilitate compliance with the major GCP responsibilities of the investigational site in relation to product handling and accountability. The requirements in this book apply most to studies on unlicensed medicinal products, where responsibility for product accountability has been delegated to a trial pharmacist. Author: Prof Dr David Hutchinson ISBN: 978-1-912055-69-2 Price Band: D Guide to GCP for Clinical Data Management This is an essential read for clinical data management teams. It covers the key ICH GCP E6(R2) requirements relevant to members of the data management team and provides valuable practical advice. Content is based on an overall GCP checklist and provides detail on staff qualifications and training, clinical data management processes, computerized systems, data flows, standards for source data, quality checks, documentation, outsourcing and risk-based approaches. Authors: Mark Elsley, Prof Dr David Hutchinson ISBN: 978-1-912055-79-1 Price Band: D 15 Golden IND/GCP Rules for Investigators Professor David Hutchinson Professor David Hutchinson A Guide to GCP for Clinical Data Management Mark Elsley Click for product demo Click for product demo Click for product demo
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