|
12 Golden GCP Rules for Investigators
|
|
|
12 Golden GCP Rules for Investigators
by Prof David Hutchinson
A quick and easy to read, illustrated, ‘bullet point’ guide to ICH GCP for investigators and other members of the study team. Contains relevant extracts from the ICH GCP guidelines.
Available in numerous languages, each translated and adapted by clinical research specialists. Full details on our main website.
ISBN 978-1-903712-70-2 English
|
|
|
|
|
12 Golden GCP Rules for Investigators (EU)
|
|
|
12 Golden GCP Rules for Investigators
by Prof David Hutchinson
A quick and easy to read, illustrated, ‘bullet point’ guide to ICH GCP for investigators and other members of the study team. Contains relevant extracts from the ICH GCP guidelines.
Available in numerous languages, each translated and adapted by clinical research specialists. Full details on our main website.
ISBN 978-1-903712-13-9 French
ISBN 978-1-903712-19-1 German
ISBN 978-1-903712-39-9 Spanish
|
|
|
|
|
12 Golden GCP Rules for Investigators (CEE)
|
|
|
12 Golden GCP Rules for Investigators
by Prof David Hutchinson
A quick and easy to read, illustrated, ‘bullet point’ guide to ICH GCP for investigators and other members of the study team. Contains relevant extracts from the ICH GCP guidelines.
Available in numerous languages, each translated and adapted by clinical research specialists. Full details on our main website.
ISBN 978-1-903712-75-7 Czech
ISBN 978-1-903712-69-6 Polish
ISBN 978-1-903712-14-6 Bulgarian
ISBN 978-1-908278-04-3 Turkish
|
|
|
|
|
12 Golden GCP Rules for Investigators (Asia)
|
|
|
12 Golden GCP Rules for Investigators
by Prof David Hutchinson
A quick and easy to read, illustrated, ‘bullet point’ guide to ICH GCP for investigators and other members of the study team. Contains relevant extracts from the ICH GCP guidelines.
Available in numerous languages, each translated and adapted by clinical research specialists. Full details on our main website.
ISBN 978-1-903712-80-1 Chinese
ISBN 978-1-903712-04-7 Japanese
ISBN 978-1-903712-12-2 Russian
|
|
|
|
|
Essential Good Clinical Practice
|
|
|
by Professor David Hutchinson
ISBN 978-1-903712-66-5
An essential guide to GCP for sponsors and investigators contains information in an easy to read format, with questions to consolidate knowledge and an answer section. 60 pages, perfect bound paperback.
|
|
|
|
|
15 Golden IND/GCP Rules for Investigators
|
|
|
15 Golden IND/GCP Rules for Investigators
ISBN 1 903712 07 6
by Professor David Hutchinson
This easy to read illustrated bullet point guide describes the investigators responsibilities when performing a clinical trial in accordance with US IND regulations (21 CFR Parts 312, 50, 56, 54 and 11) as well as the ICH GCP guidelines.
|
|
|
|
|
10 Golden GCP Rules for Pharmacists
|
|
|
10 Golden GCP Rules for Pharmacists
ISBN 1 903712 23 8 (Second edition 2005)
This easy to read, illustrated bullet point guide highlights the responsibilities of pharmacists when performing clinical trials. It has global applicability. The book is based on ICH GCP guidelines. It includes a separate summary of EU clinical trials Directive 2001/20/EC. Provides best practice advice and relevant information on compliance with EU Directive 2005/28/EC and GMP. Ideal when used in combination with the poster.
|
|
|
|
|
12 Golden ISO14155:2011 Rules for Medical Device Trials
|
|
|
12 Golden ISO14155:2011 Rules for Medical Device Trials
ISBN 978-1-908278-05-0
by Professor David Hutchinson & Dr Joris Bannenberg
This 2010 edition summarises the requirements of the International Standard 14155:2011 and provides best practice advice in an easy to read guide with bullet points and illustrations. The book is essential for sponsors and investigators of medical device trials. Globally applicable requirements.
|
|
|
|
|
Indexed ICH GCP Guidelines
|
|
|
Indexed ICH GCP Guidelines
ISBN 0 9531174 2 1
Available in two formats: ‘Carry around’ pocketbook (A6 size)and larger A5 version. Both contain the ICH GCP Guidelines together with a unique index (compiled by Prof David Hutchinson) that allows the user to search for the appropriate sections using subject index and key words.
Indexed ICH GCP Guidelines (A5 version)
Larger text, A5 desk size version
ISBN 1-903712-18-1
The ICH GCP guidelines with a unique keyword and subject index. In A5 size to aid readability but not as transportable as the pocketbook (A6 version).
|
|
|
|
|
Key requirements affecting clinical trials in Europe
|
|
|
Key requirements affecting clinical trials in Europe
ISSN 978-1-903712-77-1
Second edition
This book is an indexed compilation of the key requirements affecting clinical trials in Europe.
It contains the ICH GCP Guidelines E6(R1), EU Directives 2001/20/EC, 2005/28/EC, 2003/94/EC, Annex 13 (July 2010) and the 1996 & 2008 versions of the Declaration of Helsinki.
The book also contains a unique index that cross references all documents using key words.
|
|
|
|
|
The UK Clinical Trial Regulations: indexed and consolidated
|
|
|
The UK Clinical Trial Regulations: indexed and consolidated
3rd edition
ISBN 978-1-903712-84-9
A wire-bound book containing 180+ pages of a consolidated version of the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031),
incorporating the modifications brought about by Statutory Instruments that came into force in 2005, 2006, 2008, 2009 and 2010.
The book also has a useful subject index to help the reader find the appropriate sections.
The book also comes with a CD containing the official Statutory Instruments as PDFs.
|
|
|
|
|
A summary of Regulations and guidelines affecting clinical research/ICH regions
|
|
|
A summary of Regulations and guidelines affecting clinical research in the ICH regions
ISBN 978-1-903712-45-0
The 34 page A5 size book provides a short summary about each requirement
It does not contain the guidance/regulation itself. It contains chapters containing executive summaries of
- the ICH guidelines (E section)
- subdivisions of the FDA, EMEA and Japan's MHLW
- key US regulations (21 CFR Parts 11, 50, 54, 56, 312, 812 and the FDAAA 2007)
- Rules governing medicinal products in Europe (Volumes 1-10)
- key EU Directives (2001/20, 2005/28, 2003/94, 95/46)
- forms commonly used in the USA and Europe
|
|
|
|
|
Interpreting Medical Records
|
|
|
Interpreting Medical Records
ISBN 1 903712 06 8
by Dr Graham Hornett & Prof David Hutchinson
This carry around pocketbook will help monitors, auditors, medical students, nurses and doctors trained outside the UK to interpret and understand the abbreviations and notations used in medical records. The book contains hundreds of medical abbreviations, clinical research terms and qualifications.
|
|
|
|
|
CRF Designer
|
|
|
CRF Designer
ISBN 0 9531174 7 2
This 124 page soft cover book is a practical guide to case report form (CRF)design and production. Written by Debbie Kennedy, an experienced CRF designer and data manager, the book provides useful tips and advice as well as standard templates for CRF pages used in clinical trials. A free CD is provided with each book. This contains electronic versions of the stand template pages. The book contains information on how to modify and customise these pages.
|
|
|
|
|
Computer Validation - a User Guide
|
|
|
Computer Validation - a User Guide
ISBN 1 903712 03 3
This practical guide by Lisbeth Tofte Hemmingsen, a senior international QA Director, will help those who use computers in clinical trials. It provides valuable information to assist with computer validation, a process required by many regulatory authorities including the FDA (21 CFR Part 11). A free CD is provided with the book - this contains templates of documents needed to undertake the validation process.
|
|
|
|
|
Declaration of Helsinki 2008 Pocketbook
|
|
|
Declaration of Helsinki 2008 Pocketbook
Seoul, October 2008 version
ISBN 978-1-903712-65-8
Presented as a small A6 size pocketbook
Latest version as adopted by the World Medical Association General Assembly in Seoul, South Korea, October 2008
Customisation of cover available. Contact us directly.
|
|
|
|
|
12 Golden GCP Rules for Veterinary Studies
|
|
|
12 Golden GCP Rules for Veterinary Studies
ISBN 0 9531174 8 0
by Prof David Hutchinson and Cathy Garden
The final Veterinary ICH GCP (VICH GCP) guidelines have been summarised into 12 ‘rules’. This easy to read, illustrated, bullet point guide will help study site teams to comply with their VICH GCP responsibilities.
|
|
|
|