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NHS GG&C Clinical Research Facility Glasgow Clinical Research Facility (CRF), the clinical operational component of Glasgow Clinical Trials Unit, provides support ... – PowerPoint PPT presentation

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NHS GGC Clinical Research Facility
Glasgow Clinical Research Facility (CRF), the
clinical operational component of Glasgow
Clinical Trials Unit, provides support required
for clinical research in Greater Glasgow and
Clyde (GGC). Funded since 2006 by the Chief
Scientist Office the CRF works closely with NHS
researchers, academic partners, contract research
organisations, pharmaceutical and medical device
companies. Currently located in the Western
Infirmary and Yorkhill Children's hospital the
CRF will be moving to exciting new purpose
designed research premises over the next two
years with the opening of a satellite unit in
Glasgow Royal Infirmary in 2013 and the new
co-located adult and childrens CRF in the new
Southern General Hospital 2014. The new
developments will increase CRF capacity to
support researchers involved in academic and
commercial research in primary and secondary care
and complex trials from Phase I- IV.
  • The CRF currently employs over 60 staff
    comprising of four functional teams
  • Project Management
    Research Education Training
  • Administration Research
    Nurses
  • The project management team provide the full
    range of clinical research project management
    services from start-up to study closure for both
    CTIMP and non-CTIMP projects. The team are fully
    integrated with CRF and Research Development
    (RD) staff providing a seamless service to
    investigators and sponsors.The team can be
    contacted by email on ResearchPMU_at_ggc.scot.nhs.uk
  • The research, education training team design
    and deliver GCP training to staff undertaking
    research involving GGC patients, a requirement
    for GGC RD research approval. The team work
    closely with NRS partners and deliver GCP
    training across Scotland. We have also developed
    a range of bespoke courses to support our CRF
    nursing team, for example, Informed Consent.
    Course 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

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Where do we work?The CRF team support research
in both primary and secondary care in GGC . 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 GGC , 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
forDelivering, 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
NHS Greater Glasgow Clinical Research Facility
  • 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 GGC 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
    Investigators 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
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