NOTE: some covers have hyperlinks to sample pages

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

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:
Valerie Dumon Jones & Guy Nickols
German:
Regina Freunscht
Spanish:
Encarna Calle & Gemma Capmany

All translated versions are in the same easy to read, illustrated bullet point format as the English version.

RUSSIAN

BULGARIAN

JAPANESE

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

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

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

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

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

Investigator Guides