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Advisor newsletter: advance news items
Clinical research news is breaking all of the time.
Clinical Research & Clinical Quality Assurance Advisor newsletters provide reviews and summaries of the latest
developments.
In addition, we plan to offer our readers the chance to learn about the latest
news even faster. Our bulletins on this website provide information
even faster than the newsletter.
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NEW
Sample pages |
The UK Clinical Trial Regulations,
Indexed and Consolidated (3rd Edition)
ISBN 978-1-903712-84-9
The August 2010 changes made to the UK Clinical Trial Regulations of 2004 have been included
in the third edition of this book.
The new version incorporates the original Statutory Instrument 2004 No. 1031
and the changes brought about by 2005 No. 2754, 2005 No. 2759, 2006 No. 1928,
2006 No. 2984, 2007 No. 289, 2008 No. 941, 2009 No. 1164 and 2010 No. 1882.
The latest Statutory Instrument included, No. 1882 of 2010, related to the
Advanced Therapy Medicinal Products regulations but also affects the UK clinical
trial regulations. The latest version includes this as well as the definition of
pharmacist changes brought about by SI No. 289 in 2007.
The book is spiral (wiro)-bound, to allow flat opening, containing 180+ pages
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. £25
Discounts for large orders, contact us.
This product can be customised (cover/log) but would only be economical for
large quantities.
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NEW
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Key requirements affecting clinical trials in Europe (2nd Edition)
ISBN 978-1-903712-77-1
This spiral bound (thus opens flat) book is an indexed compilation of the key requirements
affecting clinical trials in Europe.
A5 size, approx 160 pages, wire bound for easy opening and use,
contains copies of the following guidelines/requirements:
ICH GCP Guidelines: E6 (R1)
Directive 2001/20/EC
Directive 2005/28/EC
Directive 2003/94/EC
Annex 13 (July 2010)
Declaration of Helsinki 1996 and 2008
.... and an index to cross reference all documents by key word
This product can be customised (cover/logo) - contact us for a quote
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NEW
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Chinese version
12 Golden GCP Rules for Investigators
ISBN 978-1-903712-80-1 adapted and translated by Dr Yu Zhao Bagger, Dr
Gerong Qin, Steve Hou
This guide will help Chinese reading members of the investigator site to
comply with ICH GCP.
The book is the outcome
of collaboration with Chinese clinical trial specialists Dr Yu Zhao Bagger, Dr
Gerong Qin and Steven Hou. The
latest addition means that this practical, illustrated bullet-point guide is available in English, French, German, Spanish,
Czech, Polish, Bulgarian, Russian, Japanese and now Chinese.
Pre-publication deal now on. See
the
special offer.
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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: • Introduction to good clinical
practice • Factors affecting clinical trials • GCP development • Principles of
GCP • Compliance with GCP • Documenting GCP compliance • The investigator and
study site • Addressing the risks of trials • Management of investigational
medicinal product
• The study protocol • Recruiting trial subjects • Subject protection • Data
collection in clinical trials • Safety monitoring, recording and reporting •
Analysis and reporting of trial data
• End of study procedures • GCP compliance and inspections • Due diligence is
the key
• Essential study documentation • Computerised systems • Checklists of trial
documents Order directly by email and obtain a special
reduction:
info@canarybooks.com |
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Newsletter subject index and links to PDFs
A Subscribers Only Section
An index to articles published in Advisor newsletters since issue 1 in 1997/8 is available on this website.
Click
Newsletters from the Home page and follow
the link.
The index is arranged alphabetically, classified by subject. You can
use the identified references to locate the relevant article in your back
issues of the newsletter.
Get your user name and password to access this section of the site by
emailing your subscription number to:
info@canarybooks.com
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BARQA publications
The British Association of Research Quality Assurance (BARQA) has an
extensive range of useful publications available via this site.
See the
BARQA publications section for
more information. |