The Institute of Clinical Research (ICR) has introduced a new book on the EU Directives that it hopes will promote understanding and raise standards.
The Pocket Guide to the EU Directives for Clinical Research provides a summary of the key aspects of the Clinical Trials Directive 2001/20/EC, Good Clinical Practice Directive 2005/28/EC and Good Manufacturing Practice Directive 2003/94/EC.
The publication should be read alongside the directives and provides a useful, easy to read overview.
This compact guide is written by Dr Julie Meeson FICR, a quality-assurance consultant who also provides quality assurance and training services to pharmaceutical companies and CROs.
Meeson said: 'The EU Directives are critical documents for all clinical-research professionals but can be difficult for many to understand.
'The three directives cover the most extensive changes in European Union clinical-trial legislation and our new book will help clinical research professionals better understand and use the directives in their work.' Another recent addition to the ICR's extensive range of clinical-research booklets and monographs is the ICR Guide to Freelancing, which highlights the benefits and pitfalls of freelancing and provides useful tips for anyone about to start out on their own.
For corporate and bulk purchases, the ICR can provide ICH GCP and Fundamental Guidelines booklets with customised covers, which can be distributed to staff as part of their professional development or during training courses.
The Pocket Guide to the EU Directives for Clinical Research (ISBN: 9 781905 238675) is available from ICR's online shop or from other online booksellers.
