NOTE: some covers have hyperlinks to sample pages

Sample pages

Essential Good Clinical Practice

ISBN 978-1-903712-66-5  by Professor David Hutchinson

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):

• 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

£14.50 (receive a special discount if you order directly!)

Indexed ICH GCP Guidelines

Available as a pocketbook ISBN 978-1-903712-35-1
Also available in larger A5 format ISBN 978-1-903712-18-4

‘Carry around’ pocketbook or larger text desk size 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. Suitable for Investigators, monitors, auditors and others who need regular access to the guidelines.

Pocketbook: £5.50    A5 format: £7.50
This product can be customised (cover/logo) - contact us for a quote

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

£12.50
This product can be customised (cover/logo) - contact us for a quote

Sample pages

The UK Clinical Trial Regulations,
Indexed and Consolidated (3rd Edition)

ISBN 978-1-903712-84-9

Recent 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

Sample pages

£8
This product can be customised (cover/logo) - contact us for a quote

Interpreting Medical Records

ISBN 1-903712-06-8 by Dr Graham Hornett and Prof David Hutchinson

A carry around pocketbook that contains hundreds of medical abbreviations, notations found in medical records and medical qualifications. Ideal for monitors and auditors who need to understand patient files during source data verification.

Also contains clinical research abbreviations – making it useful for study site co-ordinators and research nurses too. Doctors and other medical staff unfamiliar with the content of UK medical records will find this guide invaluable.

£7.50

Declaration of Helsinki 2008

ISBN 978-1-903712-65-8

All researchers should have read and be familiar with the contents of the Declaration of Helsinki. This small A6 size pocketbook contains the World Medical Association’s October 2008 version of the Declaration of Helsinki. This set of ethical standards underpins modern research in humans.

Can be customised (cover and logo), large orders only

 £4

CRF Designer

ISBN 0-9531174-7-2 by Debbie Kennedy

Ideal for those who need to create case report forms for clinical trials. This 124 page soft cover book is a practical guide to case report form (CRF) design and production.

Debbie Kennedy is 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 standard template pages. The book contains information on how to modify and customise these pages. 

£60

Computer Validation – A User’s Guide

ISBN 1-903712-03-3 by Lisbeth Tofte Hemmingsen

All electronic systems used in clinical trials need to be properly validated. This applies to the very simplest spreadsheet used to record trial information through to complex statistical analysis software.  Regulations and guidelines relating to electronic records and signatures must be followed by both sponsors and investigators.

This guide, written by a quality assurance director with experience and expertise in this area provides valuable advice on how to plan, set up and implement the validation of a computerised system.  Useful documents templates that can be individually adapted are provided on a free CD-ROM.

£25

ENGAGE Guidelines

ISBN 1-903712- 01-7 by Expert working group and EFGCP

This pocketbook presents the optional guidelines for GCP compliance and quality systems auditing.

The guidelines, based on international quality standards such as ICH GCP and ISO, were developed by an international group of experts, in collaboration with EFGCP.

£5