Brookwood Global's e-books brochure 2023

Brookwood Global’s e-books

Contents Introduction Our e-books: Indexed ICH GCP E6(R2) Guidelines European Clinical Trial Regulation 536/2014 Key Requirements Affecting Clinical Trials in Europe (5th Edition) UK Clinical Trial Regulations, Indexed and Consolidated (3rd Edition) Essential Good Clinical Practice 12 Golden GCP Rules for Investigators 15 Golden IND/GCP Rules for Investigators 10 Golden GCP Rules for Pharmacists Guide to GCP for Clinical Data Management

Good Clinical Practice for Laboratories General Data Protection Regulation 2016/679 A Guide to European Data Protection PV for ALL – Guide to recognizing and reporting

product safety information Essential Pharmacovigilance

Essential Guide to Non-interventional Studies 12 Golden ISO14155:2011 Rules for Medical Device Trials OECD Principles of GLP with unique index The Essentials of How to be a Great Manager

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Brookwood Global has published books and newsletters in clinical research and related areas for over 30 years. Our books include reference texts as well as useful best-practice guides. The books are now available in electronic format and can be read on a variety of devices and computers. As a bespoke alternative, all of our e-books can be fully customized in your own colours bearing your corporate logo. In our own small way, we are helping to reduce climate change. To reduce our carbon footprint, paper versions are only being published for our popular indexed ICH GCP guidelines book. Printed copies of all other publications can be ordered if bulk or customized copies are required. Why buy our e-books? • A lower carbon footprint as a result of less paper use, printing and shipping. • Convenient to view on phones, tablets and PCs. • No weight to carry around, so no more heavy reference texts! • Fully indexed and easier to navigate than a printed version. • Attractive designs and turning pages.

• Lends itself to easy updating and changes. • Group use packages available … a cost-effective way to share with colleagues and investigator teams. • Our reference books have unique Brookwood-developed subject indexes that help you to navigate to the section you need in just one click. • Click the provided link and view it online 24/7 for as long as your access is allowed. • Individual book options and bespoke packages available. How it works • Each book is supplied as a subscription for online access for one year. • The cost of each book is based on a price banding and the number of users wanting to have access. • Up-to-date prices are found on our website. • Purchases for one to 20 users can be made on the website. • Contact us directly for group subscriptions of more than 20 people. • Customized bookshelves available. • Books can be customized. • Printed versions available by special order.

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European Clinical Trial Regulation 536/2014 A uniquely indexed reproduction of the European Clinical Trial Regulation 2014 No. 536 as published in the Official Journal on 27 May 2014. The unique Brookwood index of subject headings and key words helps users find the appropriate sections quickly and easily. The index also cross-references the Clinical Trials Directive 2001/20/EC, the Declaration of Helsinki and ICH GCP. ISBN: 978-1-912055-68-5 Price Band: B

Indexed ICH GCP E6(R2) Guidelines

Key Requirements Affecting Clinical Trials in Europe (5th Edition) This publication combines the key requirements and guidelines with a unique subject index that allows the user to search for the appropriate sections using key words. It brings together the globally accepted ICH GCP E6(R2) guidelines, the three major EU Directives affecting clinical trials – Directive 2001/20/EC (including amendments since 2001), Directive 2005/28/EC, Directive 2003/94/EC – Annex 13 (July 2010) relating to investigational medicinal products and both the 1996 and 2013 versions of the Declaration of Helsinki. ISBN: 978-1-912055-71-5 Price Band: B

This publication contains a uniquely indexed version of the ICH Harmonised Guideline entitled “Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)”. It was published by ICH in November 2016 and has now reached Step 5 in many regions and countries. Brookwood’s unique subject index allows easy navigation to the required sections. ISBN: 978-1-912055-54-8 Price Band: A

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Available in English, French, German, Spanish, Czech, Polish, Bulgarian, Chinese, Japanese, Russian and Turkish.

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UK Clinical Trial Regulations, Indexed and Consolidated (3rd Edition) This “Brookwood indexed” reproduction of the original Statutory Instrument 2004 No. 1031 also incorporates, into a single consolidated text, the little-known changes brought about by the later Statutory Instruments 2005 No. 2754, 2005 No. 2759, 2006 No. 1928, 2006 No. 2984, 2007 No. 289, 2008 No. 941, 2009 No. 1164 and 2010 No. 1882. The book’s unique subject index helps the reader find the appropriate sections more easily. ISBN: 978-1-912055-72-2 Price Band: B

Essential Good Clinical Practice This book by Prof David Hutchinson is an overview of the requirements laid down by the ICH GCP E6(R2) guidelines. This is an essential guide to GCP for sponsors and investigators. It provides information and practical advice in an easy-to-read format, with a question and answer section to consolidate knowledge. This is a must for novices to clinical research and is also a good recap for the more experienced monitors, auditors and investigators. Author: Prof Dr David Hutchinson ISBN: 978-1-912055-74-6 Price Band: C

12 Golden GCP Rules for Investigators

Every investigator should have a copy of this book! It is an easy-to-read guide for investigator site personnel performing trials to international ICH GCP E6(R2) standards. It breaks investigator responsibilities down into 12 bite-size chunks, the “golden rules”, providing the key GCP requirements, practical advice and a reproduction of the relevant ICH GCP section for each rule. It aims to facilitate and enhance regulatory compliance at the study site. Author: Prof Dr David Hutchinson ISBN: 978-1-912055-57-9 (English) Price Band: D

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ProfessorDavidHutchinson

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15 Golden IND/GCP Rules for Investigators

10 Golden GCP Rules for Pharmacists

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

This quick and easy to read, illustrated, bullet point 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

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

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Good Clinical Practice for Laboratories This guide is ideal for laboratory staff,

General Data Protection Regulation 2016/679

A Guide to European Data Protection

This book is a reproduction of the European General Data Protection Regulation 2016 No. 679. It incorporates a unique subject index to help the reader find the relevant section in this substantial document. It is a companion publication to “A Guide to European Data Protection” (see next column), which summarizes the key points of this regulation. ISBN: 978-1-912055-76-0 Price Band: B

This excellent summary of the European Data Protection Regulation (GDPR) of May 2018 is a must-read for everyone who processes, stores or transfers personal data. It outlines the key requirements to facilitate compliance. The book breaks down the regulation into bite-size chunks to make the difficult topic easier to understand. Authors: Dr Lisbeth Tofte Hemmingsen, Prof Dr David Hutchinson ISBN: 978-1-912055-75-3 Price Band: D

investigator site teammembers, sponsors, monitors, auditors and others involved in the analysis of clinical trial samples. The content is based on the European Medicines Agency’s “Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples” (2012) and the relevant principles of ICH GCP E6(R2). Authors: Prof Dr David Hutchinson, Sharon Jordan ISBN: 978-1-912055-80-7 Price Band: D

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This publication can be fully customized to include your Company and Local Safety Contact details – contact us for more information

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PV for ALL – Guide to recognizing and reporting product safety information

Essential Pharmacovigilance This book is relevant to everyone involved in pharmacovigilance, both directly and indirectly through their role. It focuses on the key principles of pharmacovigilance rather than on every small detail of the guidelines and regulations, which will inevitably change. Authors: Dr Lisbeth Tofte Hemmingsen, Prof Dr David Hutchinson ISBN: 978-1-912055-78-4 Price Band: C

Essential Guide to Non-interventional Studies This book will help those involved in or wanting to learn more about non-interventional studies (NIS). It contains key information on both the general principles and the practical aspects of running NIS. It describes the regulations, guidelines and best practices that govern them. It also gives an insight into the study designs that can be considered for NIS. This book is an informative resource for those who are already involved in ‘real world research’. Authors: Dr Lisbeth Tofte Hemmingsen, Prof Dr David Hutchinson ISBN: 978-1-912055-55-5 Price Band: D

This short easy-to-read booklet is for all staff in an organization who might encounter a product safety issue. From telephone receptionist to General Manager/CEO, regulators expect that someone who is told of a product safety issue must know how to handle it. This book helps the reader to recognize product safety issues when they are told of them, and then how to manage them. Authors: Dr Lisbeth Tofte Hemmingsen, Prof Dr David Hutchinson ISBN: 978-1-912055-56-2 Price Band: E

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12 Golden ISO14155:2011 Rules for Medical Device Trials DavidHutchinsonand JorisBannenburg

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12 Golden ISO14155:2011 Rules for Medical Device Trials Anyone involved in clinical trials on medical devices should read this bullet-point guide. The ISO rules regarding the clinical investigation of medical devices for human subjects have been broken down into digestible chunks. Each “golden rule” provides the relevant requirements and some practical advice to facilitate regulatory compliance. Authors: Dr Joris Bannenberg, Prof Dr David Hutchinson ISBN: 978-1-912055-70-8 Price Band: D

OECD Principles of GLP with unique index

The Essentials of How to be a Great Manager This book provides essential guidance for managers new to the role, and shows them how to develop a team that is happy, innovative and productive. This clear and concise handbook is quick and easy to read, and can be used as a complete reference guide, as a checklist or as a tool to refresh knowledge in specific areas. Although aimed at new managers, it is a valuable resource for managers at all levels of seniority. Author: Mark Elsley ISBN: 978-1-912055-77-7 Price Band: C

If you need access to the Principles of GLP then this book is for you. It contains the OECD Principles of GLP as revised in 1997 [C(97)186/Final] together with Brookwood’s unique subject index to facilitate finding the key information more easily. ISBN: 978-1-912055-81-4 Price Band: A

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