EU Directive 2001/20/EC
Regulations were published
on 1 April 2004 to transpose EU Directive 2001/20/EC into UK law with effect
from 1 May 2004. From this date, all ongoing and new trials within the scope of
the Directive must be authorised by the Medicines and Healthcare products
Regulatory Agency (MHRA). Compliance with the UK Regulations includes holding a
Clinical Trial Authorisation (CTA) and having a sponsor.
The Directive defines the sponsor as the person (eg an individual, company,
institution, company or organisation who takes responsibility for the
initiation, management and financing (or arranging the financing) of a clinical
trial". The UK Regulations make it possible for the responsibilities of the
sponsor to be accepted by an investigator, a single organisation, or a group of
individuals and/or organisations. A copy of the Regulations can be viewed on
www.hmso.gov.uk/si/si2004/20041031.htm. A Joint Project has been set up by
the Medical Research Council/Department of Health in England to identify and
document current best practice in the areas that have been regulated and to
provide advice on systems and approaches based on best practice that will comply
with the law. Guidance produced by the Joint Project can be found on
http://www.ct-toolkit.ac.uk.
CSO Policy on Sponsorship for Trials Covered by the EU Clinical Trials Directive
CSO does not intend assuming sponsorship responsibility for trials coming within the scope of the EU Directive. Applications for CSO funding through its research grant, studentship and fellowship schemes will therefore need to identify an alternative organisation as the sponsor.
Sponsorship for all other Studies
Studies not falling within the ambit of the EU Directive will still require a sponsor to be appointed under the Scottish Executive Health Department Research Governance Framework for Health and Community Care (RGF). In line with the position adopted for trials under the Directive, CSO does not intend assuming sponsorship responsibility for studies falling within the scope of the RGF.