Joint Research Office
Office Location:
1st Floor Maple House
149 Tottenham Court Road
London W1T 7DN
Postal Address:
UCL,
Gower Street
London WC1E 6BT
Tel No. 0845 1555 000 ext 9995 Fax No 020 7380 9937
Web-sites: www.uclh.nhs.uk; www.ucl.ac.uk
National Institute for Health Research
University College London Hospitals NHS
Foundation Trust
Research and Development
Operational Capability Statement
*Approved by:
*Date approved:
*Version:
*Publication date:
UCLH Board
Oct 28th 2011
1.1
Oct 31st 2011
Review date:
Author:
Responsible Director
and Responsible Committee:
Target audience:
Nov 1st 2012
Dr Susan Kerrison
Prof Tony Mundy,
Clinical Research Governance Committee
All research staff, academic and commercial
research collaborators.
All Research, Management and
Governance Standard Operating
Procedures.
25
Related documents/policies:
Number of pages and appendices:
1
Index of tables
R&D Management Arrangements
Organisational Details
Key contacts
Staffing of the R&D Office
Reporting Structure
Research Networks
Current Collaborations and Partnerships for research activity
page 3
Study Capabilities
page 11
Types of studies that can be supported to the relevant regulatory standards
Licences relevant to research
Services to support Research
Clinical Services Departments
Management contacts for R&D governance activities
page 12
Research and Development Interests
Areas of research interest
Local / National Specialty group membership
page 18
Research and Development Planning and Investment
Planned investment
page 21
Research and Development Operational Procedures Register
Standard Operating Procedures
Processes for managing Research Passports
Escalation Process
page 23
Planned and Actual Studies Register
page 24
Other Information
page 24
2
Organisation R&D Management Arrangements
Information on key contacts
Organisation Details
Name of Organisation
R&D Lead / Director (with responsibility for reporting on R&D to the Organisation Board)
Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details
Contact 1:
Role:
Managing Director of Research Support Centre
Name:
Dr N McNally
Contact Number:
PA Margaret Norton 020 7679 6639
Contact Email:
n.mcnally@ucl.ac.uk
Contact 2:
Role:
Deputy Director of Research Support Centre
Name:
Dr Rajinder Sidhu
Contact Number:
020 3447 9995
Contact email:
r.sidhu@nhs.net
Contract 3:
Role:
Head of Risk and Regulation
Name:
Dr Susan Kerrison
Contact Number:
020 3447 9995
Contract email
s.kerrison@ucl.ac.uk
Contact 4:
Role:
Head of Finance
Name:
Joe Mwanza
Contact Number:
020 3447 9995
Contact Email:
joe.mwanza@uclh.nhs.uk
Contact 5:
Research Management and Governance Network Manager
Role:
TBC
Name:
Contact Number:
Contact Email:
3
UCLH NHS FOUNDATION TRUST
Prof M Mythen
Information on staffing of the R&D Office
R&D Office Roles
Network co-ordinators and network
administrators
Whole Time Equivalent
7
Comments
Provide advice on study approval processes, set up and governance arrangements for investigators,
research teams and Trusts in the consortium.
Clinical Trials staff
12
Finance Officers
5
Clinical Trials Staff including regulatory affairs officers, pharmacists, monitors and quality assurance
managers are employed by UCL.
Assists in the development of costing and financial management of all types of studies.
Contracts Managers/Legal Affairs
4
Administrators
4
Statisticians
5.5
Reviews, drafts and negotiates contracts and other agreements for all types of research studies including
international studies.
Provide administrative support for Joint Research Office, Research Support Centre and CBRC.
Joint with UCL Statistical Science, Institute of Neurology, UCL Mental Health Sciences and PRIMENT
CTU.
4
Reporting Structures
Scope
The Joint Research Office manages the clinical research portfolios of UCL Hospitals NHS Foundation Trust, Royal Free Hampstead NHS Trust and UCL. The
JRO reports both to UCLH and UCL and through a Service Level Agreement to Royal Free. The JRO director is Director of R and D for UCLH. Research is
governed by a Clinical Research Governance Committee which reports both to Quality and Safety Committee at UCLH, the RF Hampstead Risk and Regulation
Committee and the UCL Research Governance Committee.
5
Research Networks
Research Network (name/location)
Central and East London Comprehensive Research Network
North London Cancer Network
Thames Stroke Network
Dendron
Role/relationship of the Research Network e.g. host Organisation
Member
Host for the Network. http://ncrndev.org.uk/index.php?option=com_content&task=view&id=90&Itemid=180
Host for the Network http://thames.uksrn.ac.uk/
Co-ordinating Centre. http://www.dendron.org.uk/
Information on collaborations and partnerships for research activity (e.g. BRC, BRU, Other NHS Organisations, Higher Education Institutes, Industry)
Current Collaborations / Partnerships
Organisation Name
Details of Collaboration / Partnership (e.g. University/Organisation Joint Office, external
provider of pathology services to Organisation, etc, effective dates)
Margaret Norton;
Http://www.uclh.nhs.uk/research/cbrc
m.norton@ucl.ac.uk 020 7679 6639
UCLH/UCL National Institute for Health
Research Biomedical Research Centre
Funded by the National Institute for Health Research (NIHR), the UCLH/UCL NIHR
Biomedical Research Centre (BRC) is an outstanding partnership between University
College London Hospitals (UCLH) and University College London (UCL). The Centre is a
leader in translating fundamental biomedical research into clinical research that benefits
patients. The BRC supports research projects by investing in staff posts, equipment,
facilities and training. It stimulates success in competitive funding with grant income rising
to £160m in 2009/10. Twenty-three of the Centre investigators are NIHR Senior
Investigators. The Centre has particular strengths in cancer, cardiovascular disease,
neurosciences, women’s health, medical imaging, and gene and cell therapy. Research
Support Services for the BRC are managed by the Joint Research Office.
UCL Partners- founding partners. UCL,
University College London Hospitals
NHS Foundation Trust. Royal Free
Hampstead NHS Trust, Great Ormond
Street Hospital for Children NHS Trust
and Moorfields Eye Hospital NHS
Foundation Trust.
UCL Partners is a collaboration between five of Britain’s world-renowned medical
research centres and hospitals which aims to create Europe’s strongest academic health
science partnership. Its focus is on cutting edge research driven by patients and their
needs, and on how treatments are rolled out to give the greatest benefit to the greatest
number, while making health services more efficient and affordable. The current list of
UCLP themes includes cancer, neurosciences, cardiovascular, immunology and
transplant, eye and vision, child health and women’s health.
Barbara Cummins - For more
information visit www.uclpartners.com
Barbara Cummins@uclpartners.com
6
Contact Name/Email address
UCL. UCLH , UCLP Yale Collaboration
UCLH/UCL Clinical Research Facility
Cancer Research UK and UCL Cancer
Trials Centre
UCL and Yale University have formed an alliance to improve global health through
scientific research, clinical and educational collaboration. The agreement brings together
the skills and expertise of UCL, UCL Partners, Yale University and Yale-New Haven
Hospital. Both UCL and Yale University are world ranking centres of biomedical research.
The new collaboration will immediately create new joint clinical programmes to treat
cardiomyopathy, congenital heart disease, sudden cardiac death and chronic total
occlusion of the coronary arteries. In addition to exchanging expert physicians to treat
individual cases at each site, the members of the collaboration will make use of
telemedicine technology to share clinical information and expertise among themselves,
and eventually with other institutions around the world. The system of comprehensive
clinical care delivered by UCL’s NHS-affiliated hospitals in particular UCLH will enable
joint longitudinal studies and clinical trials of new medicines which could greatly benefit
patients.
Funded by NIHR, Welcome Trust and Wolfson Foundation, the Clinical Research Facility
provides a purpose built environment to accommodate experimental medicine including
Phase 1 trials. With 20 beds, a new clinical laboratory, an endoscopy room, a physiology
suite, a dispensary and a trial pharmacy, the CRF provides a safe and efficient setting in
which the highest quality research can be conducted as rapidly and effectively as
possible. The CRF hosts studies from a wide range of disciplines and specialties funded
by public and private sector funders.
The Cancer Trials Centre is a research department within the UCL Cancer Institute.
Over the last 12 years, the CTC has grown to be one of the largest cancer trials centres in
the UK and now is one of the 9 accredited clinical trials units of the National Cancer
Research Institute (NCRI). With over 70 staff, based close to UCLH, the CTC manages
all aspects of trial design, conduct and analysis including the specialist requirements of
international and phase 1 trials. The latter are conducted through the Experimental
Cancer Medicine Centre at UCL using the UCLH Clinical Research Facility. During the
last five-year review period, 43 new trials opened, with a combined target accrual of
12,210 patients.
The CTC is responsible for a significant proportion of the National Cancer Research
Network (NCRN) academic trials portfolio. Studies arise through experience and national
contacts with clinical academics, the Clinical Studies Groups of the NCRI, and local
collaborations at UCL. Trials at the CTC cover a range of tumour areas, most of which
are based on evaluating chemotherapy, radiotherapy or surgery.
7
http://www.yale-ucl.org
http://www.uclh.org/Research/CRF/
Ground floor Elizabeth Garrett
Anderson Wing
235 Euston Road
London NW1 2BU
General enquiries
Telephone: 0845 155 5000 ext 76036
http://www.ctc.ucl.ac.uk
PRIMENT Clinical Trials Unit
UCL Biobank for studying Health and
Disease (based at Pathology-Rockefeller
building and the UCL-Cancer Institute
PRIMENT is collaboration between the UCL Departments of Primary Care and Population
health and Mental Health Science and MRC. It is a UKCRC Registered Clinical Trials
Unit and conducts research clinical trials and other large studies on mental illness,
common mental disorders and other common clinical conditions in primary care. It has
particular strengths in research on primary care, mental health, health services research,
cardiovascular medicine and child health.
The Biobank will support research will storing relevant tissues and bodily fluids including
snap-frozen or cryopreserved tissue, formalin-fixed tissue, paraffin-embedded tissues,
and slides prepared for histological examination, whole blood, serum, plasma, urine,
cerebrospinal fluid, milk, saliva and buccal smears and cytological specimens. It will also
store fine needle aspirates obtained from tissues and bodily cavities (e.g. pleura and
peritoneum) will also be collected. Where appropriate the Biobank will also store
separated cells, protein, DNA and RNA. Some of the tissue and aspirated samples will be
stored in the diagnostic archive. Holders of samples and data in other locations across
UCLP (including frozen or fixed tissues, plasma, sera, DNA and RNA) will be invited to
add information on their holdings to the BioBank Research database hosted by UCL. This
will not only hold information about the sample, but also the diagnosis and other clinical
information as available. The Research Database, which is being developed with
Canadian company, Genologics, will be web-accessible, so that researchers across the
Globe can identify sample holdings and thus initiate collaborative research. All data and
samples will remain the property of the person who collected them.
http://www.priment.mrc.ac.uk
http://www.ucl.ac.uk/biobank/
The Research Design Service North London lead by Profs Michael King and Irwin
Nazareth from PRIMENT. RDS is focused on supporting applications for funding from
NHS researchers and those working in partnership with the NHS. Priority is given to those
applying for NIHR Research for Patient Benefit (RfPB) funding. The Service provides
help to those preparing research proposals for submission to peer-reviewed funding
competitions for applied health or social care research. The advice is provided free of
charge and is available through use of online resource and consultations with experts
Research Design Service North London
Bringing together, all of the large applied research and clinical institutions in London RDS
provides from a network of specialist advisors based at the partner institutions with
internationally recognised expertise in applied research methods in health and social
care. RDS London can advise on all aspects of preparing grant applications, including:
* Formulating research questions
* Building an appropriate research team
* Involving patients and the public
* Designing a study
* Appropriate methodologies
8
http://www.rdslondon.co.uk
* Regulatory and ethical issues
* Advice on writing lay summaries
* Identifying the resources required for a successful project.
Francis Crick Institute - formerly UK
Centre for Medical Research and
Innovation
Sara Cannon Research UK
UCL was selected, against strong competition, to host the new UK Centre for Medical
Research and Innovation, a multi-million pound investment between Cancer Research
UK, the Medical Research Council, Wellcome Trust and UCL to establish a world class
medical research centre in central London. This builds on major investment in
translational research infrastructure in the Wolfson Institute for Biomedical Research and
will bring almost 1,000 scientists onto the UCLH/UCL site, offering exciting new
opportunities for research.
Sarah Cannon Research Institute (SCRI) and UCLH/UCL Cancer Clinical Trials Facility
have formed a partnership to expand early phase clinical trials, share expertise and
develop training opportunities. SCRI is a US based strategic research organisation
focusing on accelerating drug development. SCRI runs one of the cancer clinical research
programmes in the US, conducting community based trials in cancer, cardiology and
gastroenterology.
UCLH and RFH are both part of UCL School of Medical Life Sciences. Many active
research collaborations exist across both sites. Research Support Services for RFH are
managed by Joint Research Office.
Royal Free Hampstead NHS Foundation
Trust
http://www.crick.ac.uk
http://sarahcannonresearch.com
JRO (R and D)
Admin Corridor
Room 9649
Medical School Building
Royal Free Hampstead NHS Trust
Pond Street
NW3 2QG
020 7794 0500 x38900
Whittington Hospital
Whittington Hospital is part of a UCL Consortium for Research Management and
Governance. The consortium collaborates over the promotion of clinical research and
delivery of high quality, consistent and streamlined processes for clinical research
management.
Research Management and
Governance Department
Undergraduate Centre
Whittington Health
Magdala Avenue
N19 5NF
0207 288 3405
9
North Middlesex Hospital
Royal National Orthopaedic Hospital
Stanmore (RNOH)
Barnet and Chase Farm NHS Trust
Great Ormond Street Hospital for
Children NHS Trust
The North Middlesex Hospital is part of a UCL Consortium for Research Management
and Governance. The consortium collaborates over the promotion of clinical research
and delivery of high quality, consistent and streamlined processes for clinical research
management.
RNOH is part of a UCL Consortium for Research Management and Governance. The
consortium collaborates over the promotion of clinical research and delivery of high
quality, consistent and streamlined processes for clinical research management.
Barnet and Chase Farm NHS Trust is part a UCL Consortium for Research Management
and Governance. The consortium collaborates over the promotion of clinical research
and delivery of high quality, consistent and streamlined processes for clinical research
management.
There are extensive collaborations between the NIHR Biomedical Research Centre at
GOSH and the BRC at UCLH/UCL. An agreement also exists for the management of
academic clinical trials between GOSH and the Joint Research Office.
North Middlesex University Hospital
Trust
Sterling Way
London
Greater London
N18 1QX
(020) 8887 2000
Iva.hauptmannova@rnoh.nhs.uk
Royal National Orthopaedic Hospital
Brockley Hill, Stanmore, Middlesex,
HA7 4LP.
020 8954 2300
Barnet Hospital
Wellhouse Lane
Barnet, Herts
EN5 3DJ
Chase Farm Hospital
The Ridgeway
Enfield, Middlesex
EN2 8JL
0845 111 4000
R&D Office
UCL Institute of Child Health & Great
Ormond Street Hospital
30 Guilford Street
London. WC1N 1EH
Tel: 020 7905 2700
Fax: 020 7905 2201
Moorfields Eye Hospital NHS Foundation
Trust
The UCLH/UCL Biomedical Research Centre works collaboratively with the NIHR BRC at
Moorfields. Agreements are also in place for the management of research
10
http://www.ucl.ac.uk/ioo/
Institute of Ophthalmology
11-43 Bath Street, London,
EC1V 9EL
Organisation Study Capabilities
Information on the types of studies that can be supported by the Organisation to the relevant regulatory standards
Types of Studies Organisation has capabilities in (please tick applicable)
Other Clinical Studies
CTIMP’s (indicate Phases)
Clinical Trial of a Medical Device
Human Tissue:
Tissue Samples
Studies
As Sponsoring
Organisation
All types of CTIMP’s are sponsored
through collaboration with UCL
All types of Medical Device trials are sponsored through
collaboration with UCL
yes - single site
yes
As Participating
Organisation
All phases
All phases
yes
yes
As Participant
Identification Centre
All phases
All phases
yes
yes
Which licences does the organisation hold which may be relevant to research?
Organisation Licences
Licence Name
Example: Human Tissue Authority Licence
HTA Post Mortem
HTA Human Applications
Contained Use Regulations
FWA
Licence Details
License Number 12054
Wolfson Cellular and Gene Therapy Unit Number 11025
CU1 notification GM 3048
FWA00003017
11
Organisation Services
Information on key clinical services contacts and facilities/equipment which may be used in studies for supporting R&D governance decisions across the organisation.
Clinical Service Departments
Service Department
Pathology- Biochemistry
Pathology- Histology/Cytology
Specialist facilities that may be provided (e.g. number/type of scanners)
Clinical Biochemistry provides a continuous 24 hour routine biochemistry service
from the laboratory at 60 Whitfield Street. We process approximately 6000 blood
tubes each day and analyse more than 6 million tests every year. A specialist
service offers tests for the investigation of renal stone disease, endocrine disorders
and protein abnormalities. The laboratory also offers a wide range of dynamic
function tests including acid load, cloniden stimulation and TRH. The routine and
specialist biochemistry services are both CPA accredited.
Cellular Pathology is a consultant led diagnostic service which includes
Histopathological and Neuropathological diagnosis using paraffin embedded tissue. It
has full CPA accreditation and many of our consultant histopathologists are
acknowledged authorities in their fields, some on an international level. Routine
histopathological diagnoses is provided using both standard techniques and
advanced diagnostics including immunocytochemistry, fluorescent in-situ
hybridisation (FISH), and polymerase chain reaction (PCR).
The Cytology service undertakes many highly specialist procedures such as
Immunocytochemistry including FISH and Molecular pathology including PCR and
methylation technology as well as diagnostic cytology on effusions, fluids, and
washings/brushings from respiratory and digestive tracts, and urine, cervical cytology
screening is undertaken using liquid-based cytology (LBC) and the service
undertakes fine needle aspirates (FNAs) from a variety of body sites eg lumps in the
breast and neck.
12
Contact Name within Service Department
Dr. J. Land
john.land@uclh.nhs.uk
Dr. M. Falzon
Mary.falzon@uclh.nhs.uk
Pathology - Microbiology
Pathology - Haematology
Pathology- Virology
The Department of Clinical Microbiology is a CPA accredited laboratory processing
300 000 specimens a year. Located within the Department is one of four London
HPA (Health Protection Agency) Collaborating Centres.
The department also has a joint academic function with UCL and partakes in
research and undergraduate and postgraduate teaching.
Services include Routine bacteriology culture and serology, Mycology, TB diagnostic
service, Antibiotic assay, GU medicine culture and serology, Chlamydia culture,
serology and PCR, Anaerobic microbiology, Infection control, Public Health
investigations and consulting, Consultation on infectious disease management,
Advice on decontamination, Clinical TB service and Bedless consult service
(including critical care / ITU).
Dr. Bruce Macrae
Bruce.macrae@uclh.nhs.uk
The Department of Haematology and Blood transfusion is a CPA accredited
laboratory that provides routine and specialist diagnostic and monitoring services.
The Blood Transfusion laboratory provides blood groups, antibody screening,
antibody identification, and annual provision of over 60,000 units of blood products to
the hospitals within UCLH NHS Foundation Trust. The department supports the
special product requirements for the Neonatal Unit, Fetal Medicine Unit, Leukaemia
Transplant Unit, TTP apheresis unit and the Haematology/Oncology day care suite.
The Flow Cytometry laboratory provides diagnostic malignancy markers and
cytochemical staining for chronic and acute leukaemia and lymphoma. The majority
of the Flow Cytometry workload consists of lymphocyte subsets for HIV monitoring.
Their test repertoire also includes CD19 levels, platelet surface markers and
screening for paroxysmal nocturnal haemoglobinuria. The Haemoglobinopathy
Genetics and Special Haematology laboratories provide extensive
haemoglobinopathy investigations and pre-natal diagnosis service. The laboratories
have close links with pre-natal and antenatal counsellors. The Haemostasis
laboratory provides comprehensive thrombosis and bleeding disorder investigations
and provides an extensive referral service for outside hospitals.
Prof. Sam Machin
Sam.machin@uclh.nhs.uk
The Diagnostic Virology Service is CPA accredited and receives in excess of
100,000 requests per year. In addition to the routinely available tests used to
diagnose and monitor viral infections, the translational unit of the department
develops and provides novel molecular diagnostic assays.
The Laboratory is an acknowledged reference laboratory for HIV, hepatitis B,
hepatitis C and molecular diagnosis and has a special interest and expertise in:
Eleni.nastouli@uclh.nhs.uk
1 HIV and other retroviral infections
2 Viral hepatitis, especially hepatitis B and C infections
3 Transfusion-related microbiology
4 Viral infections in the immune compromised patient
5 Viral infection of the foetus
13
Pathology - Parasitology
Pathology - neuropathology
and neuroimmunology
Imaging – University College
Hospital
The Department offers a wide range of investigations including diagnosis and
identification of parasites in clinical material, diagnosis of human parasitic disease by
immunological methods, culture and genomic detection of Leishmania and culture of
Acanthamoeba from clinical material. A twenty-four hour service for microscopic
diagnosis of malaria is available. An advisory service on investigation of patients for
parasitic disease, the appropriateness of tests, their timing and interpretation
together with advice on treatment is also available. Individual tuition for technical,
scientific and medical staff in faecal and blood parasitology can be provided by
special arrangement. The Department of Clinical Parasitology processes over 25,000
requests per annum. The Department of Clinical Parasitology also houses and runs
the NEQAS (Parasitology) laboratory and the UK NEQAS-associated teaching
facility.
David.manser@uclh.nhs.uk
Peter.chiodini@uclh.nhs.uk
Neuropathology provides specialist histopathology services for specimens from brain
and spinal cord tumours and epilepsy lobectomies (ca.1000 p.a.). Diagnostic
biopsies are peripheral nerves (ca. 100 p.a.) and muscle biopsies (ca 250 p.a.), CSF
cytology (ca. 800 p.a.). Further, the department performs neuropathological post
mortem examinations including prion disease (CJD, ca 40 per year).
and provides research services for Research Departments at the Institute of
Neurology (UCL). The Department also hosts the Dubowitz Neuromuscular centre
with ca 200 paediatric muscle biopsies per year, including national referrals through
the NCG referral scheme. Molecular pathology diagnostic tests are qPCR for
Chromosomes 1p/19q in oligodendrogliomas and MGMT methylation PCR in
malignant gliomas.We carry out routine molecular tests for PTEN loss, EGFR
amplification and IDH-1 and IDH-2 mutations in low and high grade gliomas.
The Neuroimmunology & CSF Laboratory (NICL) provides and develops the more
specialist tests needed to support the diagnosis and treatment of neurological
patients both within the UCLH Trust and nationally.
Prof Sebastian Brandner
sebastian.brandner@uclh.nhs.uk
The team of radiologists, radiographers, nurses, admin and clerical staff and support
staff provide both diagnostic imaging and interventional treatments to a wide range of
patients. The state of the art equipment includes multi-slice CT, 1.5T MRI, digital
plain film, ultrasound and digital angiography - all linked to the Trust-wide PACS
system. Equipment includes 3 x CT scanners, 3 x 1.5T MRI scanners – routinely
used for clinical work. 1 x 3T MRI (50% clinical / 50% research)
14
http://www.ucl.ac.uk/ion/divisions/neuropathology/
Michael.lunn@ucl.ac.uk
http://www.ucl.ac.uk/ion/departments/neuroinflam
mation/themes/neuroimmunology
shonit.punwani@uclh.nhs.uk
Imaging National Hospital for
Neurology and Neurosurgery
Pharmacy
3 MRI scanners(2, 3T and 1,1.5T)
AMRIS (Single plane Angio, 1.5T MRI, Theatre Suite)
128 slice CT scanner
Bi-plane Angiography Suite
Digital radiography room
2 ultrasound scanners
3 mobile C arm image intensifiers
2 mobile X-ray units
The Pharmacy clinical trials team is a dedicated group of Pharmacists, Technicians
and Support Officers who manage pharmacy's ongoing commitment, support and
development of clinical trials within the Trust. The team is well renowned nationally
and often presents at conferences, training days and its opinion and guidance is
often sought by external trial units nationally. The clinical trials team has developed
the award winning CTMS (clinical trial management system) / PICTON (pharmacy
interactive clinical trial online network) alongside the pharmacy IT system
development team and plan to release this nationally at the end of 2006. Dedicated
facilities for the storage and handling of clinical trial material exist within UCLH.
Manufacturing, clinical trial packaging and Qualified Person resources can also be
arranged via the clinical trials team if required. Prior to study opening, it is important
to include the pharmacy department as early as possible in the proposal process
(preferably prior to R&D and ethics submissions).The pharmacy provides: Pharmacy
GCP Clinical Trial Support, MHRA licensed Pharmacy manufacturing unit (Specials
and IMP) and Qualified Person (QP).
15
Susan Wakeling
susan.wakeling@uclh.nhs.uk
Rita Gupta
rita.gupta@uclh.nhs.uk;
pharmacy.clinicaltrials@uclh.nhs.uk
Nuclear Medicine
Nuclear Medicine provides a comprehensive clinical service performing some 15,000
patient studies per year, incorporating a full range of nuclear medicine procedures
conducted for both the Trust and hospitals throughout the UK. The Department uses
the UK's first 16 and 64-slice PET/CT systems, three SPECT/CT systems including
one operated with UCL Cancer Institute as a research-dedicated machine, two
further SPECT gamma cameras including a novel solid-state, ultra-fast dedicated
cardiac SPET system (the first of its kind in Europe), DXA bone densitometry and
supporting instrumentation. We also perform a range of routine and experimental
inpatient and outpatient radionuclide therapy procedures, and the INM has access to
ten dedicated radionuclide therapy beds. In 2012 operation of a PET/MR service in
the new Cancer Centre will be commenced; the first in the UK. The department has
specific clinical research interests in the use of PET/CT, SPECT and multi-modality
imaging as investigative tools in oncology, cardiology, neurology/psychiatry,
nephrology, the study of osteoporosis and novel techniques for radionuclide
therapy.2 x PET/CT scanners (64-slice and 16-slice CT);
1 x PET/MRI scanner (First in UK active in April 2012);
4 x gamma cameras, three with SPECT/CT capability.
1 x CZT dedicated cardiac SPECT camera
1 x DEXA BMD system
On-site Radiopharmacy
Outpatient and Inpatient Radionuclide Therapy facilities
16
Dr. J. Bomanji
Institute of Nuclear Medicine
jamshed.bomanji@uclh.nhs.uk
Information on key management contacts for supporting R&D governance decisions across the organisation.
Management Support e.g. Finance, Legal
Services, Archiving
Department
Specialist services that may be provided
Contact email
Archiving
The JRO has a dedicated archivist to provide advice and organise procedures for
archiving of studies.
www.ucl.ac.uk/jro
Contracts
Research Contracts are managed within the JRO by a dedicated team of four legally
trained contracts managers who review, draft and negotiate contracts and other
agreements for all types of research studies including international studies.
The team provides advice on study approval processes, set up and governance
arrangements for investigators, research teams and Trusts in the consortium.
www.ucl.ac.uk/jro
www.ucl.ac.uk/jro
Information Technology
The finance team consists of a Head of Finance plus a dedicated team of accounts
administrators. The team assists in the development of costing and financial management
of all types of studies.
Information technology is supplied by UCLH through a contract with Logica
Personnel
Personnel and HR support is provided by UCLH
www.uclh.nhs.uk
Statistical support and training
JRO Biostatistics group provides scientific and intellectual support to investigators
throughout the research pathway. It aims to design analyse health care studies and
conduct research on the statistical methodology required for the solution of biomedical
problems.
www.ucl.ac.uk/jro
caroline.romain@uclh.nhs.uk.
Research Management and Governance
Finance
17
www.ucl.ac.uk/jro
www.uclh.nhs.uk
Organisation R&D Interests
Information on the areas of research interest to the Organisation
Organisation R&D Areas of Interest
Area of Interest
Cancer
Details
Contact
Within cancer we have the interest and capabilities to run all types of
studies ranging from generic phase I trials including first-in-man studies
through to phase II and III. All relevant anti-cancer treatment modalities are
studied within UCH including trials of IMPs, surgical techniques,
radiotherapy and new/novel technologies. Links with UCL allow for a
highly developed clinical trials programme and extended translational
research programme. All tumour areas treated within the hospital
undertake research activities with particular strengths being in
haematology, lung, gynaecological, brain and urological cancers as well as
sarcomas and tumours in teenagers and young adults.
Cardiovascular disease
Heart failure, heart surgery and congenital heart disease. Fibrosis/amlyloid,
remote ischaemic conditioning and genetics of HCM.
Cellular and Gene Therapy
Gene therapy for monogenic disease, engineered T cells, mesenchymal
stem cell therapy.
Ear Nose and Throat
Regenerative medicine for ENT disorders including bioengineered thorax.
Cochlear implant development and drugs for tinnitus.
Gastroenterology and Hepatology
Imaging
Infectious Diseases
Relationships between inflammation, function and disease in the gut and
liver. Risk stratification and interventions for of IBD, hepatitis and
cirrhosis/liver failure. Photodynamic therapies for the treatment of
pancreatic and biliary tract cancers. Albumin-augmented dialysis.
Research using plain MRI and SPECT. PET, PET/CT, PET/MRI
phenotyping. Guided therapy. 1 x 3T MRI (50% clinical / 50% research) .
Life MRI during neuro surgery using AMRIS (Single plane Angio, 1.5T
MRI, Theatre Suite).
Development of molecular diagnostic tools for infectious diseases and of
infection-resistant equipment for clinical environments (computer
keyboards, beds and telephones), introduction of rapid MRSA screening,
wound surveillance programme. HIV, hospital acquired infections, imported
infections, SLE, complications of autoimmune arthritis.
18
www.uclh.nhs.uk/research/CBRC/Researchthemes and
ncrndev.org.uk/index.php?option=com_content&task=view
&id=90&Itemid=180.
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
Active research programmes in epilepsy, MS and stroke. MRC Centre for
research and treatment of neuromuscular disease, Dementia research
centre and UK's first scanner which allows surgeons to image brain during
surgery.
Focuses on causes of orofacial disease and the prevention, repair and
regeneration of resultant tissue abnormalities, and translation of such
findings into clinical practice. Tissue engineering - understanding the
fundamental phenotypic and functional responses to novel biomaterial
compositions, control of infection including diseases caused by oral microorganisms, other members of the indigenous microbiota and bacteria
associated with skeletal pathology and genetic susceptibility.
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes;
www.dementia.ion.ucl.ac.uk;
http://www.ucl.ac.uk/ion/departments
Paediatrics
Paediatric oncology, adolescent medicine, diabetes, paediatric urology
especially reconstruction
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
Respiratory, anaesthetics and
critical care
Respiratory medicine – focusing on lung cancer, pulmonary infection and
pulmonary fibrosis
Perioperative optimisation, monitoring and outcome – improving surgical
outcomes
Infection, sepsis and organ dysfunction – understanding, preventing and
treating infection and organ failure in the intensive care unit
Obstetric anaesthesia
Brain injury and neuro critical care – improving outcomes after brain injury.
Surgery
Head and Neck surgery, Trauma and Orthopaedics, Urology and
Ophthalmology
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
Urology
MRI for diagnosis of prostate cancer. Multi-focal therapy.
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
Neurology and neurosurgery
Oral Health
Women’s Health
Gynaecological cancer, sexual and reproductive health, reproductive
endocrinology, prenatal screening and diagnosis, perinatal brain injury and
development, and the prediction and outcome of maternal disease. Nursing
and midwifery research. Screening for ovarian cancer.
19
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes;
http://ucl.ac.uk/eastman/research/index.html
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
see
http://www.uclh.nhs.uk/research/CBRC/Researchthemes
Information on Local / National Specialty group membership within the Organisation which has been shared with the CLRN
Specialty Group Membership (Local and National)
UCLH hosts the following networks
 Cancer - North London Cancer Research Network
 Dementia and Neurodegenerative diseases – Dendron
 Stroke - Thames Stroke Network
UCLH is actively involved in the following networks
 Anaesthetics
 Cardiovascular
 Clinical Genetics
 Critical Care
 ENT
 Gastrointestinal
 Hepatology
 Immunology and Inflammation
 Infectious diseases and Microbiology
 Injuries and Accidents
 Metabolic and Endocrine
 Musculoskeletal
 Nervous system disorders
 Non malignant Haematology
 Oral and Dental Health
 Paediatrics
 Public Health Research
 Renal
 Reproductive Health and Childbirth
 Respiratory
 Surgery
 Urogenital
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Organisation R&D Planning and Investments
Planned Investment
Area of Investment
(e.g. Facilities, Training, Recruitment, Equipment etc.)
UCL Centre for Medical Image Computing
UCLH/UCL NIHR Clinical Research Facility (CRF)
UCL Clinical Trials Unit
Description of Planned Investment
In 2011 installation of the first whole-body PET/MRI in the UK and an interventional 3T MRI
scanner (part Wolfson-funded) will commence in the new MacMillan Cancer Centre. Working
together with the UCL Centre for Medical Image Computing and UCL Centre for Medical Image
Computing, imaging will be incorporate into all research programmes.
The UCLH/UCL NIHR Clinical Research Facility (CRF) unites the Wellcome Trust Clinical
Research Facility, and a Cancer facility focused on early phase trials and incorporating the
CRUK/NIHR Experimental Cancer Medicine Centre. Close interaction is maintained with other
UCL CRFs at Great Ormond Street Hospital (GOSH) and Moorfields. Support for clinical trials is
provided by the UCL Clinical Trials Unit, established in 2010, in collaboration with the MRC
Clinical Trials Unit (co-located at UCL, with joint academic positions). We aim to expand this
facility over the next 5 years including, for instance, a specialist support centre for neurointervention trials. In 2011, UCL and associated hospitals supported 119 Phase I/II Clinical Trials,
of which 50% were commercially sponsored. This figure was an increase of 50% over the
previous year, and places UCLH in the top 5% of all UK NHS Trusts in terms of the number of
active clinical trials.
Ten core funded academic, research posts and technical posts have been established.
Infrastructure and information systems funding has been allocated to support the development of
a NIHR registered academic CTU. The CTU has been established to facilitate the delivery of
high quality regulatory compliant clinical trials of both investigational medicinal products (IMPs),
non-IMP trials and other studies. Clinical and non-clinical academic trialists provide the
experience and skills to input into various aspects of trial methodology from design through follow
up to analysis and reporting, health economics and data services. CTU based trialist will work
alongside clinical academics at UCL and UCL partner organisations building on existing
collaborations with the MRC CTU and other UCL based CTUs (Priment and UCL CRUK Cancer
Trials Unit). The UCL CTU is working with specialist trial centres including those focusing on
neurology, surgery and musculo-skeletal disorders to develop process and infrastructure both for
the central hub and linked trial centres.
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National Institute for Health Research Biomedical Research Unit in
Dementia
Academic Careers Office for Biomedical Research Centre, UCL and UCL
Partners
Centre for Nurse and Midwife led Research
http://cnmr.org.uk/
Proton Beam Therapy
UCL Institute of Sport, Exercise and Health
http://www.ucl.ac.uk/surgicalscience/departments_research/institute_smeh
The Dementia BRU will focus on young onset dementias in order to achieve our aims of
developing new methods of diagnosis and treatment.
Our objectives are to discover new disease genes and develop rapid clinical testing. We will use
genetic information to guide studies of the molecular processes of neurodegeneration by growing
neurons (brain cells) from skin biopsies taken from patients known to carry dementia genes.
From these studies we will develop new candidate treatments, evaluated using new measures
and trial methodologies derived from the longitudinal study of genetically at risk cohorts; these
approaches will also support industry studies. Discoveries will be rapidly extrapolated to older
patient groups through links with other BRUs and our own UCLH/UCL collaborators.
Development of the Academic Careers Office, to co-ordinate and link training across the BRC,
UCL and UCL Partners to address training for research throughout whole career pathway both for
clinicians and for a multidisciplinary workforce including nurses and non clinical support staff.
Capacity will be built in education and biostatistics and a number of interdisciplinary post
graduate courses will be developed. As well as traditional taught courses, web based learning,
short courses, mentorship schemes and industrial placements will be developed. The ACO also
co-ordinates the Grand Challenges Studentship scheme.
The CNMR aims to build the capacity and capability of nurses and midwives to engage in and
lead healthcare research. The CNMR facilitates nurses and midwives to gain support and
education related to all aspects of healthcare research through one to one appointments,
seminars, lectures, conferences, workshops, writing grants and outreach. The CNMR provides
resource information and links to other research support services within UCLH to facilitate the
development of research ideas. The CNMR also forges links with collaborators such as City
University, the Burdett Trust and the Royal College of Nursing to ensure access to high quality
nursing and midwifery research support.
UCLH has been designated as one of the two primary sites for the delivery of Proton Beam
Therapy in the UK. This advanced form of radiotherapy can target tumours far more precisely
than conventional methods. It is particularly beneficial for many child cancers, brain, head and
neck cancers and sarcomas. The new service will be situated close to the Trust new Cancer
Centre. It will bring together some of the world’s leading specialists in complex cancers with the
opportunity to drive forwards research into this new form of treatment.
The institute will integrate all sports and exercise related research at UCLH and UCL. The
Institute has a number of external partners including English Institute for Sport and British
Olympic Association. As well research aimed at optimising athletes for London 2012, the Institute
will also extend knowledge on the role of sport and exercise in common health problems such as
cardiovascular disease and diabetes.
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Sainsbury Wellcome Centre
The Centre is a partnership between Wellcome Trust and the Gatsby Charitable Foundation.
Neuroscientists working at the Centre will use state of the art molecular and cellular biology and
imaging, electrophysiology to investigate how brain circuits process information.
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Organisation R&D Standard Operating Procedures Register
Standard Operating Procedures
SOP Ref Number
SOP Title
JRO RMG RSS SOP 1
JRO RMG RSS SOP 2
JRO RMG RSS SOP 3
JRO RMG RSS SOP 4
JRO RMG RSS SOP 5
JRO RMG RSS SOP 6
JRO RMG RSS SOP 7
JRO RMG RSS SOP 8
JRO RMG RSS SOP 9
JRO RMG RSS SOP 10
JRO RMG RSS SOP 11
JRO RMG RSS SOP 12
JRO RMG RSS SOP 13
JRO RMG RSS SOP 14
JRO RMG RSS SOP 15
SOP on the development RMG RSS SOPs
Sponsorship of "simple" studies
Sponsorship of "complex" studies
Arrangements for assessing study feasibility - draft
NHS permissions
Set up and control of external agreements
Honorary contracts and letters of access
Procedure for study amendments, progress reports and end of study.
Reporting and escalation of study events and incidents
R and D systems events
Audit and monitoring
Study closure - notification and archiving
Requirements for site file
Partner and member level responsibilities
Handling study events
Information on the processes used for managing Research Passports
Indicate what processes are used for managing Research Passports
From 1st June 2011, all research passports, and letters of access for NHS staff will be handled by the R&D department. As each project is reviewed, by a research
coordinator, the contractual requirements will be assessed. The investigator will be informed about the level of contract they require and the appropriate forms will be made
available to them for completion by their employing organisation. When NHS permission is provided, the appropriate Honorary Research Contract or Letter of Access will be
issued.
For further information contact: Rajinder Sidhu at: r.sidhu@nhs.net
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Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes
Escalation Process
The escalation process mirrors Trust management policies in relation to Trust incidents. All concerns or complaints about research systems or incidents related to research
systems are managed in line with JRO RMG RSS SOP 10. The procedure is to enter such incidents onto a database and report to the Director of Research Support. The
Director initiates a root cause analysis into all concerns or incidents which are considered moderate or severe. Catastrophic incidents are reported to and investigated by
the Director of Research and Development. All incidents which are investigated are discussed by the Senior Management Team. Where necessary, procedures reviewed
and amended, information should be feedback to JRO staff, training needs identified, the outcome and any relevant action plan reported back to complainant. Reports of
all investigations are presented to Research Support Centre Leadership Committee.
Planned and Actual Studies Register
ULCH research portfolio is maintained on the REDA database. The Trust approves around 190 studies every year of which 55 are CTIMPs. At any one time there will 1195
studies will be actively recruiting at UCLH including 292 CTIMPs. Further information about the UCLH portfolio can be obtained from s.kerrison@ucl.ac.uk.
Other Information
For example, where can information be found about the publications and other outcomes of research which key staff led or collaborated in?
Other Information (relevant to the capability of the Organisation)
UCLH is one of the major sites for clinical research in Europe. In 2011, UCLH and associated hospitals supported 119 Phase I/II Clinical Trials, of which 50% were
commercially sponsored. This figure was an increase of 50% over the previous year, and places UCLH is in the top 5% of all UK NHS Trusts in number of active clinical
trials. The numbers of patients recruited into trials during the period 2008-11 totalled 20,201. The UCLH/UCL NIHR Clinical Research Facility (CRF) unites the Welcome
Trust Clinical Research Facility, and a Cancer facility focused on early phase trials and incorporating the CRUK/NIHR Experimental Cancer Medicine Centre. We aim to
expand this facility over the next 5 years, including, for instance, a specialist support for neuro-intervention trials. Support for clinical trials is provided by the UCL Clinical
Trials Unit, established in 2010, in collaboration with the MRC Clinical Trials Unit (co-located at UCL, with joint academic positions). UCLH also has specialist research
imaging facilities including those required for brain research and is a collaborator in a number of bio banks. The website www.uclh.nhs.uk/research provides information
about the research activities of UCLH. Information about UCL themes, departments and publications which are related to work undertaken at UCLH can be found at
www.iris.ucl.ac.uk.
25