|
NOTE: some covers have hyperlinks to sample pages |
 |
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

|
All translations from the original English version have been undertaken by
experienced clinical research personnel, working with GCP and QA in
a pharmaceutical company setting.
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

|
All translations from the original English version have been undertaken by
experienced clinical research personnel, working with GCP and QA in
a pharmaceutical company setting.
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
|
|
All translated versions are in the same easy to read, illustrated bullet
point format as the English version. |
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 |