Clinical Trials Guidance
The following provides an introduction to some of
the regulatory aspects of setting up and running studies.
The Christie NHS Permission
All research conducted within The Christie must be registered
with, and approval by, the trusts research and development office
prior to any research activity commencing.
Investigators are encouraged to contact the research and
development office early to register projects and obtain an
internal project reference number. Please submit your ethics
application and protocol to register your study and initiate
permission process here at The Christie.
All projects that have resource implications for the trust are
reviewed by the trusts Clinical Trials Resource Group (CTRG), a
multi-disciplinary committee representing the major service support
and finance departments of the trust. CTRG meetings are held
monthly and investigators must submit their study documents 10 days
before the scheduled meeting.
NHS Permission for research will be issued in the form of a
signed letter once any issues raised by the CTRG have been resolved
and evidence of all applicable regulatory approval has been
provided.
Peer Review
All research protocols must have undergone adequate independent
peer review prior to ethical and local NHS permission. Where a
protocol has been successfully submitted for a funding applicable,
or is from a commercial organisation, peer review is generally a
part of the funding proves. Evidence of this peer review process
should be supplied to the R&D office.
For non-commercial investigator-led clinical research, which has
not been independently reviewed, the research and development
office will arrange suitable reviews on behalf of the investigator.
Please note that the names of any reviewers will be kept
anonymous.
Trust Sponsorship
It is a requirement of the Research Governance Framework for
Health and Socail Care (2005) and, for clinical trials of
investigational medicinal products, the Medicines for Human Use
(clinical trials) Regulations 2004 that all reserach has an
identified sponsor.
Where a protocol has been developed by an employee of The
Christie NHS Foundation Trust and no external sponsor is identified
the Trust may take on the responsibility of research sponsor. Any
investigator wishing to identify The Christie NHS Foundation Trust
as the sponsor for their study should contact Angela Ball to
discuss the study.
Other links
For further information on regulatory aspects of the setup of
clinical trials please follow the useful links below:-
