12 Golden GCP Rules for Investigators

ISBN 978-1-903712-70-2 (January 2009)
by Prof David Hutchinson

Quick and easy to read, illustrated, ‘bullet point’ guide to ICH GCP for investigators and other members of the study team.

This popular book will help investigators comply with ICH GCP investigator responsibilities and items on the monitor’s wish list! Contains relevant extracts from the guidelines.

Also available in

French German Spanish
Czech, Polish, Bulgarian
Chinese, Japanese, Russian
US version: with 15 rules
(see details below)

£8 (English and all translated versions)

Turkish version
12 Golden GCP Rules for Investigators

ISBN 978-1-908278-04-3  adapted and translated by Doç. Dr. M. Devrim Güner

This guide will help Turkish reading members of the investigator site to comply with ICH GCP.
The latest addition means that this practical, illustrated bullet-point guide is available in English, French, German, Spanish, Czech, Polish, Bulgarian, Russian, Japanese, Chinese and now Turkish.

FRENCH

GERMAN

SPANISH

French:
ISBN 978-1-903712-13-9 translated by
Valerie Dumon Jones & Guy Nickols
German: 
ISBN 978-1-903712-19-1 translated by Regina Freunscht
Spanish:
ISBN 978-1-903712-39-9 translated by
Encarna Calle & Gemma Capmany

CZECH

POLISH

BULGARIAN

Czech:
ISBN 978-1-903712-75-7
translated by MUDr Eva Kráčmarová
Polish: 
ISBN 978-1-903712-69-6 translated by Dr Magdalena Kozak
Bulgarian:
ISBN 978-1-903712-14-6
translated by Dr Tsvetalina Tankova & Dr Ivaylo Simeonov

RUSSIAN

CHINESE

JAPANESE

Russian:
ISBN 978-1-903712-12-2
translated by Professor Olga Kubar,
Chair of the Forum of Ethics Committees of the Confederation of Independent States
Chinese:
ISBN 978-1-903712-80-1 
adapted and translated by Dr Yu Zhao Bagger, Dr Gerong Qin, Steve Hou
Japanese:
ISBN 978-1-903712-04-7
translated and adapted by
Shigeyuki Usami
 

15 Golden IND/GCP Rules for Investigators

ISBN 978-1-903712-42-9 (Third edition, Sept 2009)
by Prof David Hutchinson

This illustrated, bullet point guide is quick and easy to read.

It presents 15 golden rules for investigators and members of the study team who need to be aware of their responsibilities when performing a trial in  accordance with the US Investigational New Drug (IND) application requirements (21CFR Part 312).

£8

10 Golden GCP Rules for Pharmacists

ISBN 978-1-903712-23-8 (Second edition, May 2005)
by Prof David Hutchinson

Pharmacists are often forgotten when it comes to trial briefings.

This quick and easy to read, bullet point, illustrated guide provides vital information that enables trial pharmacists to comply with their important GCP responsibilities. Contains relevant extracts from ICH GCP guidelines and provides best practice advice based on the latest Royal Pharmaceutical Society guidelines. The book also summarises the requirements of European Directives 2001/20/EC, and takes into account Directive 2005/28/EC, GMP and Annex 13.

£8

12 Golden ISO14155:2011 Rules for Medical Device Trials

ISBN 978-1-908278-05-0
by Prof David Hutchinson and Dr Joris Bannenberg

Easy to read, illustrated, bullet point guide for sponsors and investigators doing trials on medical devices. The 12 ‘golden rules’ presented help investigators comply with the globally applicable ISO 14155:2011 standards.

Also includes best practice advice.

£8

12 Golden EN540 Rules for Investigators of

Medical Device Trials in Europe

ISBN 0 9531174 9 9 by Prof David Hutchinson and Dr Joris Bannenberg

Easy to read, illustrated, bullet point guide for study site personnel doing trials on medical devices. The 12 ‘golden rules’ presented help investigators comply with the EN540 standards regulating trial conduct.

£5