NHS GG&C Clinical Research Facility
The CRF currently employs over 60 staff comprising of four functional teams
* Glasgow
ProjectClinical
Management
* (CRF),
Research
&Trainingcomponent of Glasgow Clinical Trials Unit,
Research Facility
theEducation
clinical operational
* provides
Administration
Research
support required for clinical*research
in Nurses
Greater Glasgow and Clyde (GG&C). Funded since 2006
by the Chief Scientist Office the CRF works closely with NHS researchers, academic partners, contract
research organisations,
pharmaceutical
and
medical
deviceproject
companies.
•
The project management
team provide
the full range of
clinical
research
management
services from start-up to study closure for both CTIMP and non-CTIMP projects. The team are fully
integrated
within
CRF
and
Research
&Development
(R&D)Children's
staff providing
a seamless
Currently
located
the
Western
Infirmary
and Yorkhill
hospital
the CRF service
will betomoving to
investigators
and
sponsors.The
team
can
be
contacted
by
email
on
ResearchPMU@ggc.scot.nhs.uk
exciting new purpose designed research premises over the next two years with the opening of a satellite
in research,
Glasgow Royal
Infirmary
in 2013
and
the new
co-located
andtochildren’s
CRF in the new
• unitThe
education
& training
team
design
and deliver
GCP adult
training
staff undertaking
Southern
Hospital
2014. aThe
new developments
willresearch
increaseapproval.
CRF capacity
to work
support
researchGeneral
involving
GG&C patients,
requirement
for GG&C R&D
The team
researchers
involved
in
academic
and
commercial
research
in
primary
and
secondary
care
and
complex
closely with NRS partners and deliver GCP training across Scotland. We have also developed a range
trials
Phase
I- IV. to support our CRF nursing team, for example, Informed Consent. Course
of from
bespoke
courses
information can be found at www.glasgowcrf-education.org/courses
•
The administration team work closely with the nursing team supporting the management of study
documentation including assisting with SSI completion.
•
The research nurse team is the largest functional group within the CRF team with over 40 nurses
working on a portfolio of more than 120 studies of varying complexity across a range of specialities,
phases of clinical trials and non-CTIMP studies in both primary and secondary care. The team not only
see patients in the Clinical Research Facilities but also at the point of patient care, for example
Intensive Care Units or other clinical areas where the delivery of treatment and patient care is more
appropriately managed. The team has a wealth of clinical research experience, working in specialty
groups with a named lead nurse allocated for each study.
Our research nurse team are contracted to work out of hours allowing the CRF flexibility to support
studies requiring overnight or extended visits The CRF website can be accessed at
www.glasgowcrf.org.uk
NHS Greater Glasgow Clinical Research Facility
Where do we work?
The CRF team support research in both primary and secondary care in GG&C . We have specific primary and
secondary care research teams to facilitate the development of the specialist skills required however there
are clear pathways for integrated working. An easy example is identifying potentially eligible participants in
primary care and managing all trial visits in the CRF under the care of a PI based in secondary care.
The primary care team has set up, under the direction of our CRF GP Director, a GP affiliate group with over
fifty practices signed up to participate in research. The nurse team have developed specialist skills in using
the GP patient management systems to search eligibility and have a mixed portfolio of commercial CTIMPs
and non-commercial studies currently recruiting and meeting timelines and targets.
The secondary care team are working with over 100 studies across all of the acute hospitals in GG&C ,
including paediatrics and obstetrics, working on Chief Investigator and Principal Investigator led studies in
Glasgow. We support studies and clinical trials in for example diabetes, cardiology, respiratory,
rheumatology, hepatology ,infectious diseases, renal, transplantation, lipid management, neurology and also
a number of medical device studies.
The aims of the CRF are to continue to develop and enhance our reputation for:
Delivering, in a safe environment, care of the highest quality for patients and healthy volunteers participating
in research.
Delivering consistently high quality research data
Complying with national regulatory requirements at all times and international regulations as required when
conducting clinical research.
Developing a team of research staff with the knowledge, skills and technical expertise to support complex
research projects and clinical trials.
Exemplars
Provalid: MULTINATIONAL PROSPECTIVE BIOMARKER STUDY IN TYPE 2 DIABETES. EU funded,
Glasgow is the single participating UK site with a target recruitment of 800 patients over a 2 year period.
230 patients have been recruited from GP surgeries in 5 months, recruitment timelines are being
achieved . Using an integrated approach study participants can choose to be seen in either GP surgery or CRF.
MS Trial Recruitment Success: Commercially funded Phase IV multi-centred, multi-national CTIMP in MS
Following site initiation the GG&C hospital site was notified of study closure in a matter of days due to
competitive recruitment targets being met. In response the research team recruited and randomised 10
patients over a 2 day period before global recruitment closed, allowing the site to meet contractual targets
but importantly making the study available to the local patient population.
The PI and CRF research nursing team have been commended by pharma partners for their achievement.
Neuopathic Pain CTIMP: Commercially funded Phase IIa , multi-centred, randomised, double-blind
double-dummy, active and placebo controlled, parallel group, multiple oral administration trial.
This was a new clinical specialty for CRF nursing staff and we worked in collaboration with an experienced
Principal Investigator and nurse specialist to support and manage the study. Patients were recruited by a mix
of advertising and from the Principal Investigator’s patient base. The main challenges for the trial were
recruitment and retention of the participants as the CTIMP design included a 15 day/night block stay for
participants. The CRF had consecutive participants over a 6-8 week period. It was a logistically challenging trial
but something we are happy to repeat. The overall experience was very successful with positive feedback
from the sponsor, participants and the research team.