Since June 2002 ICR has offered a training course accreditation programme The goal of this scheme is to provide a lead in setting and maintaining clinical research standards in line with ICR's mission and strategy. The programme has been reviewed and updated to provide a simple flexible scheme that is cost effective for both large and small companies.
When formulating the Accreditation Policy much thought was given to the standard against which any accreditation should be made. Clinical research takes place in a global setting and is not completely harmonised as different territories have differing regulatory environments and cultural requirements. However there is one standard which is widely adopted throughout the world and which is part of many of the regulatory environments in which we work. Good Clinical Research Practice (GCP) and more specifically ICH GCP efficacy guideline E6.
The World Health Organisation (WHO) has adopted GCP:
- WHO Technical Report Series, No. 850, 1995, Annex 3
ICH GCP E6 is clearly referenced in the following territories, among others:
- USA:Federal Register Vol.62, No.90, May 9, 1997, pp. 25691-25709
- EU:CPMP/ICH/135/95/Step5, and CPMP/768/97)
EU Clinical Research Directive (2001/20/EC Article 1)
EU GCP Directive (2005/28/EC)
- Japan:March 97, PAB Notification No.430, MHLW Ordinance No.28
In order to provide an initial and common widely used framework against which clinical research courses can be accredited, ICR took as its first standard the ICH GCP Guidelines. Courses may also be accredited against the European Directives 2001/20/EC and 2005/28/EC. In raising standards ICR also developed a set of Professional Standards covering aspects of the clinical research process these also provide a framework against which clinical research courses may be accredited.
For detailed information on the professional standards see the members only pages.
For details of application for accreditation see the General Guidelines for Training Providers Submitting an Application by the Institute of Clinical Research Click Here
If you would like further information please contact accreditation@icr-global.org
