|
NOTE: some covers have hyperlinks to sample pages |
|
 |
Indexed ICH GCP GuidelinesAvailable as a pocketbook ISBN 0-9531174-2 ‘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 |
 |
Key requirements affecting clinical trials in EuropeISBN 1-903712-31-9 This spiral bound (thus opens flat) book is an indexed compilation of the key requirements
affecting clinical trials in Europe. ICH GCP Guidelines: E6 (R1) £12.50
|
|
|
The UK Clinical Trial Regulations: indexed and consolidatedISBN 978-1-903712-56-6 Our latest book "The UK Clinical Trial Regulations: indexed and
consolidated" is now available. This is a useful publication for sponsors and investigators alike. £25 Discounts for large orders, contact us.
|
 |
A summary of
|
 |
Interpreting Medical RecordsISBN 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 2008ISBN 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 DesignerISBN 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 GuideISBN 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 GuidelinesISBN 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 |
