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NOTE: some covers have hyperlinks to sample pages |
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12 Golden GCP Rules for Investigators
ISBN 0-9531174-3-X 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 (ISBN 1-903712-13-0) German (ISBN
1-903712-19-X),
Spanish (ISBN 978-1-903712-39-9),
Russian (ISBN 1-903712-12-2), Bulgarian (ISBN 1-903712-14-9)
& Japanese - ISBN 1-903712-04-1)
£8 (English and all translated versions) |
FRENCH

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GERMAN

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SPANISH

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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:
Valerie Dumon Jones & Guy Nickols
German:
Regina Freunscht
Spanish:
Encarna Calle & Gemma Capmany
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All translated versions are in the same easy to read, illustrated bullet
point format as the English version. |
RUSSIAN

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BULGARIAN

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JAPANESE

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Russian:
ISBN 1-903712-12-2 translated by Professor Olga Kubar,
Chair of the Forum of Ethics Committees of the Confederation of
Independent States
Japanese:
ISBN 1-903712-04-1 adapted and translated by Shigeyuki Usami. This guide meets both
Japanese GCP and ICH GCP requirements
Bulgarian:
ISBN 1-903712-14-9 translated by
Dr Tsvetalina Tankova & Dr Ivaylo Simeonov
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15 Golden IND/GCP Rules for Investigators
ISBN 978-1-903712-42-9 (Second edition, June 2007) 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 |
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10 Golden GCP Rules for Pharmacists
ISBN 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 |
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12 Golden ISO14155 Rules for Medical Device Trials
ISBN 1-903712-24-6 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
standards entitled Clinical Investigation of Medical Devices for Human
Subjects (Parts 1 and 2).
Also includes best practice advice. £8 |
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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 |