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ORGANISATION R&D MANAGEMENT ARRANGEMENTS Information on key contacts:
Name of organisation Royal Free London NHS Foundation Trust
R&D lead / Director (with responsibility for reporting on R&D to the organisation Board)
Dr Emma Morris Dr Adele Fielding
R&D OFFICE DETAILS
Name: Hameedah Bogle-Dawoud (Senior Research Administrator)
Address: Room G649, Ground Floor, Admin Corridor, Medical School Building, Rowland Hill Street, London, NW4 2PF
Contact number: 0207 794 0500 ext 38900
Contact email: [email protected]
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KEY CONTACT DETAILS Contact 1:
Role: R&D Director (Joint)
Name: Dr Emma Morris Contact number: 020 7794 0500 ext 33321 Contact email: [email protected] Contact 2:
Role: R&D Director (Joint)
Name: Dr Adele Fielding Contact number: 0207 794 0500 ext 33475
Contact email: [email protected]
Contact 3:
Role: Deputy Director, Research Support Centre
Name: Dr Rajinder Sidhu
Contact number: 0845 1555 000, ext 5554
Contact email: [email protected]
Contact 4:
Role: Research Network Co-ordinator
Name: Mr Stuart Braverman
Contact number: 0207 794 0500 ext 34887
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Contact email: [email protected]
Contact 5:
Role: Research Network Co-ordinator
Name: Ms Anna Jones
Contact number: 0207 794 0500, ext 38486
Contact email: [email protected]
Contact 6:
Role: Senior Research Administrator
Name: Mrs Hameedah Bogle-Dawoud
Contact number: 0207 794 0500, ext 38900
Contact email: [email protected]
Contact 7:
Role: Contracts and Legal Affairs Manager
Name: Darla Champigny
Contact number: 020 3447 5015
Contact email: [email protected]
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INFORMATION ON STAFFING AT THE R&D OFFICE R&D TEAM R&D office roles (e.g. Governance, contracts, etc)
Whole time equivalent Role
Deputy Director, Research Support Centre
0.25 Oversee R&D process.
Network co-ordinators and network administrators 2.7 Support the development and approval of sponsored and hosted studies at the Royal Free.
Finance Officers 1 Costing of research studies and financial management of ongoing research studies.
Contracts and Legal Affairs support 1 Reviews, drafts and negotiates contracts and other agreements for all types of research studies including international studies.
ATMP regulatory managers
0.2 The Regulatory Managers for advanced therapy trials provide specialist support and advice at UCL and Royal Free for trials involving ATMPs.
Archiving support
0.2 Provides guidance on GCP compliant record-keeping and maintains responsibility for the secure storage and management of archived research records at The Royal Free
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REPORTING STRUCTURES Scope The R&D Co-directors, Dr Adele Fielding and Dr Emma Morris, are responsible for the overall management and governance of research throughout the Trust. They are supported by 4 divisional R&D Directors, which represent the major research active divisions in the Trust (Professor Wisia Wedzicha and Dr Janice Tsui, plus two divisional directors to be appointed). Research management and governance functions (R&D office) are arranged and managed by the Joint Research Office (JRO) – a collaboration between University College London (UCL), University College London Hospitals NHS Trust (UCLH) and the Royal Free Hampstead. These arrangements are outlined in a service level agreement. The overall management of Research Functions are discussed at the Research and Development Committee, which meets monthly and is chaired by Dr Morris or Dr Fielding. The group includes:
Divisional R&D directors Senior R&D office staff Clinical Trials Pharmacists Senior Finance representatives Representatives from Nurse groups, and Oncology Trials Centre Other Joint Unit staff as required
The R&D Director also reports to the Hospital Management Board, and links into the Joint Research Office through the Executive Group and the Safety Committee (based at UCLH).
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Royal Free Hampstead
JRO Management
Medical Director
R&D Directors
RM&G Manager
Contracts Manager
Head of Clinical Trials
Senior Research Administrator Research Coordinators Archives and Records Manager
Contracts Managers
Regulatory Managers
Divisional R&D Directors
R&D Support
Clinical Trials Pharmacists
R&D Finance
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Trust Board
Royal Free Risk and Regulation Committee
Royal Free R&D Committee
UCL Clinical Research Governance Committee
Joint Research Office Portfolio meetings
ROYAL FREE REPORTING STRUCTURE
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RESEARCH NETWORKS Research Networks Research Network (name/location) Role/relationship of the Research Network e.g. host Organisation Central and East London Comprehensive Research Network Member
North London Cancer Network Host for the Network. http://ncrndev.org.uk/index.php?option=com_content&task=view&id=90&Itemid=180
Health Innovation and Education Cluster Improving public health in relation to COPD, Maternity Care, Prevention of Cardiovascular Disease, Migrant Health and Eyes and Vision. More information available at www.necles.org.uk
University College London Joint Research Office (JRO)
The Joint Research Office (JRO) supports the development of the clinical research portfolio of UCL, UCLH and Royal Free Hampstead. The JRO provides professional expertise in research management, biostatistics, finance, contracts, regulatory affairs and professional development. The JRO also provides research management support to a network of local trusts associated with UCL.
Paediatric European Network for Treatment of AIDS (PENTA) Member
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CURRENT COLLABORATIONS / PARTNERSHIPS 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)
Contact Name/Email address
UCL Partners - founding partners. UCL, University College London Hospitals NHS Foundation Trust. Royal Free London NHS Foundation 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 [email protected]
Royal Free Biobank
HTA 11016
Dr Mark Lowdell [email protected]
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Research Design Service North London
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.
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 * Regulatory and ethical issues * Advice on writing lay summaries * Identifying the resources required for a successful project.
http://www.rdslondon.co.uk
Barnet and Chase Farm NHS Trust
The Royal Free Ophthalmology service is provided at Barnet General Hospital and Edgware Hospital, as well as at the Royal Free. Royal Free Renal and Dermatology services also take place at Barnet General Hospital.
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Great Ormond Street Hospital for Children NHS Trust
There are extensive collaborations between the NIHR Biomedical Research Centre at GOSH and the Royal Free. An agreement also exists for the management of academic clinical trials between GOSH and the Joint Research Office.
ORGANISATION STUDY CAPABILITIES CTIMP’s Clinical Trial of a Medical
Device Other Clinical Studies Human Tissue: Tissue
Samples Studies
As Sponsoring Organisation
UCL can act as sponsor for CTIMPs taking place at the Royal Free
UCL can act as sponsor for Medical Device trials taking place at the Royal Free
Royal Free or UCL (depending on the nature of the study) can act as a sponsor for other clinical studies taking place at the Royal Free
Royal Free or UCL (depending on the nature of the study) can act as a sponsor for tissue samples studies taking place at the Royal Free
As Participating Organisation
Royal Free can act as a participating organisation for CTIMPs of all phases
Royal Free can act as a participating organisation for all Medical Device Trials
Royal Free can act as a participating organisation for all other types of clinical study
Royal Free can act as a participating organisation for all other types of tissue studies
As Participant Identification Centre
Royal Free can act as a PIC for CTIMPs of all phases
Royal Free can act as a PIC for Medical Device Trials
Royal Free can act as a PIC for all other types of study
Royal Free can act as a PIC for tissue samples studies
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ORGANISATION LICENSES Organisation licences Licence name Example: Human Tissue Authority licence
Licence details
MHRA Manufacturer "Specials" licence (MS) MS11149 MHRA Manufacturer's authorisation for investigational medicinal products (MIA(IMP))
MIA(IMP)11149
MHRA Wholesale dealer’s licence (WDL) WDL11149 Human Tissue Authority (HTA) HTA 11016
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ORGANISATION SERVICES Clinical service departments Service department
Specialist facilities that may be provided Contact name within service department
Contact email Contact number
Radiology The department provides both diagnostic imaging and interventional treatments to a wide range of patients (approximately 7,000 interventional procedures per annum, 25,000 CT examinations, 16,000 MRI examinations, 33,000 general ultrasound procedures and 87,000 plain film examinations). The consultant body comprises: 14 general radiologists, 5 interventional radiologists, and 6 neuroradiologists. The department also delivers a registrar training scheme. The state of the art departmental equipment includes two 320 slice Toshiba Acquilion CT scanners, as well as a third 54 slice Phillips Brilliance CT scanner. There are two 1.5T Phillips MRI scanners, together with a third Phillips 1.0T MRI scanner (with plans to upgrade this to a 3T machine in the near future). There is a dedicated Interventional / Cardiology suite composed of 5 rooms - all with Siemens equipment including a cardiac catheterization lab, biplanar neuro-unit and 3 general interventional rooms. There is a 16 bed recovery area and a dedicated interventional ultrasound room. A new state of the art endovascular theatre was completed in April 2010. The department uses 6 new (Siemens, GE and Philips) state of the art ultrasound machines. Plain radiography is completely digitised. All images are linked via an iSoft Radiology Information System and Philips PACS system
Lee Grant [email protected]
0207 794 0500 ext 34174 / 35501 / 34167
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(using voice recognition dictation). The entire radiology department is currently undergoing an extensive programme of complete refurbishment.
Pharmacy There is a dedicated clinical trials pharmacy service to support a wide range of academic and commercial trials. The pharmacy clinical trials team are involved in trials from the stage of protocol assessment right through to closing down of trials. The clinical trials team consists of clinical trials pharmacists and technicians. The team works closely together to co-ordinate the pharmaceutical input into approximately 160 trials and facilitate the supply and evaluation of unlicensed medicines. They work closely with medical, nursing, pharmacy and pharmaceutical industry personnel, and sit on the trust's local research and ethics committee. In addition, we have dedicated research pharmacists who work directly with researchers and the R&D team at the feasibility stage of conducting clinical trials. Pharmacy has one of the largest production units in the NHS. The unit has a IMP manufacturing licence and can support the manufacture of a wide range of IMPs for clinical trials including tablets, capsules, placebos, creams, ointments, IV, TPN, oral solutions, as well as other services such as blinding, randomisation, and comparator sourcing.
Mr Alan Wong [email protected]
0207 794 0500 ext 33119
Pathology - Haematology
The Department of Haematology and Blood transfusion is a fully 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 blood products to the Royal Free and Royal National Orthopaedic Hospital. The department supports the special product requirements for the hepatobiliary unit, liver and renal transplant unit, bone marrow transplant service and the Haematology/Oncology day care suite. The Flow Cytometry
Dr C McNamara
0207 794 0500 ext 34862
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laboratory provides diagnostic malignancy markers and cytochemical staining for chronic and acute leukaemia and lymphoma. The Haemoglobinopathy Genetics and Special Haematology laboratories provide extensive haemoglobinopathy investigations and pre-natal diagnosis service. We also provide a world class cytogentics and molecular haematology service. The pharmacy clinical trials team are involved in trials from the stage of protocol assessment right through to closing down of trials. The clinical trials team consists of clinical trials pharmacists and technicians. The team works closely together to co-ordinate the pharmaceutical input into approximately 160 trials and facilitate the supply and evaluation of unlicensed medicines. They work closely with medical, nursing, pharmacy and pharmaceutical industry personnel, and sit on the trust's local research and ethics committee. In addition, we have dedicated research pharmacists who work directly with researchers and the R&D team at the feasibility stage of conducting clinical trials. Pharmacy has one of the largest production units in the NHS. The unit has a IMP manufacturing licence and can support the manufacture of a wide range of IMPs for clinical trials including tablets, capsules, placebos, creams, ointments, IV, TPN, oral solutions, as well as other services such as blinding, randomisation, and comparator sourcing.
Pathology - Clinical Biochemistry
Clinical Biochemistry provides a continuous 24 hour routine biochemistry service on site. We process approximately 6000 blood tubes each day and analyse more than 6 million tests every year. The department offers particular specialist services in the areas of toxicology, therapeutic drug monitoring including immunosuppressant therapies, heavy metal analysis and protein biochemistry. The department hosts the Supraregional Assay Service for Cardiovascular
Dr Michael Thomas
0207 794 0500 ext 33464
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Biomarkers offering a specialist clinical and laboratory service under the direction of Dr D Nair with a long standing interest in the management of lipid disorders including familial hypercholesterolemia. In collaboration with the Genetic Knowledge Park, the department is part of the Department of Health funded project for comparison of DNA testing for FH with traditional diagnostic methods.
All services provided are fully CPA accredited.
Pathology- Histology/Cytology
Cellular Pathology is a consultant led diagnostic service with full CPA accreditation. 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 e.g. lumps in the breast and neck.
Dr Martin Young [email protected]
0207 794 0500, 35146
Pathology- Medical Microbiology
The Department of Medical Microbiology at the Royal Free site is a fully CPA accredited laboratory processing more than 460 000 specimens a year. Located within the Department is the UKCMN Regional Mycology Centre for London. The Department also has a joint academic function with the co-located UCL Centre for Clinical Microbiology and participates in laboratory and clinical research. The main themes within the Centre and Department are mycobacterial,
Professor Chris Kibbler
0207 794 0500 ext 33545
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fungal and healthcare associated infection. All consultant staff undertake undergraduate and postgraduate teaching and the Department runs three MSc courses – in Medical Mycology, Healthcare Associated Infection and Infection and Immunity. Services include routine bacteriology culture and serology, mycology, an extensive TB diagnostic service, antibiotic assay, GU medicine culture, serology and PCR, Chlamydia culture, serology and PCR, anaerobic microbiology, infection control, consultation on infectious disease management, advice on decontamination and clinical TB service. The Department provides an extensive repertoire of molecular tests, including those for TB resistance mutations, 16S, 18S, atypical respiratory pathogens and GU pathogens. MALDI-ToF mass spectrometry and HPLC techniques are also routinely used.
Pathology- Virology
The Virology laboratory at RFH has full unconditional CPA accreditation and provides a highly efficient, cost-effective and a high quality comprehensive diagnostic service. The laboratory processed and issued over 180,000 results in 2010. It is fully equipped and highly automated. In addition to the general laboratory facilities, there is a category 3 laboratory. Major items of equipment include several automated serology analysers, real-time PCR machines and automated nucleic acid extractors, a 48-capillary sequencer, a pyrosequencer, a fluorescent microscope, and an electron microscope. Virological tests provided by the laboratory include: serology and real-time quantitative PCR detection of all major virus infections; HIV, hepatitis B and hepatitis C quantification; hepatitis C genotyping; HIV, hepatitis B, hepatitis C, influenza A and CMV drug-resistance testing; HIV genotypic tropism testing, IL28B gene polymorphism testing. The laboratory is the only UK reference centre for HIV genotypic tropism assay
Dr Tanzina Haque
020 7317 7523
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and CMV Guthrie card testing. The Retrovirology unit attracts referrals from 30 HIV clinics both in the UK and Europe. The laboratory also guides the Trust infection prevention and control activities. We provide virology support in prevention and management of blood-borne viral infections in dialysis patients (~650 patients) in North Central London sector. We introduced norovirus PCR for better management of D&V outbreaks. The laboratory has an active R&D programme to develop and improve diagnostic assays according to the service need of the Trust and in response to newly developed antiviral therapies and in preparedness for emergencies and emerging infections. We have recently introduced hepatitis C drug-resistance assay in response to the availability of new anti-hepatitis C drugs. We are currently developing a multiplex PCR for gastroenteritis viruses to manage D&V outbreaks more efficiently. We also run patient-centred clinical trials to help guiding the clinicians in patient care (e.g., CMV vaccine trial; pre-emptive therapy for CMV in transplant patients).
Nuclear Medicine
Nuclear Medicine provides a comprehensive clinical service performing approximately 14,000 patient studies per year, incorporating a full range of nuclear medicine procedures conducted for both the Trust and hospitals throughout the UK. The Department has a 16 slice SPECT/CT system, two further SPECT gamma cameras (one dedicated cardiac camera) and a single head gamma camera. We also have DEXA bone densitometry and supporting instrumentation. We perform a range of routine and experimental inpatient and outpatient radionuclide therapy procedures, and we have access to five dedicated radionuclide therapy beds. There is a new on-site radiopharmacy working to GMP which also holds a manufacturing (Specials) licence and a
Margaret Hall [email protected]
0207 794 0500 ext 33213, 33215
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manufacturing authorisation (IMP). The department has wide clinical research interests. Staff of all grades and disciplines are active in research, some with extensive experience of trials from phase 1-4. There are many ongoing clinical trials within the department both locally initiated and company sponsored. Research ARSAC licenses are held for relevant studies. 4 x gamma cameras 1 SPECT/CT 1 dedicated cardiac SPECT camera 1 Triple headed SPECT camera 1 Single head camera 1 DEXA BMD system On-site Radiopharmacy Outpatient and Inpatient Radionuclide Therapy facilities
INFORMATION ON KEY MANAGEMENT CONTACTS FOR SUPPORTING R&D GOVERNANCE DECISIONS ACROSS THE ORGANISATION Department
Specialist services that may be provided
Contact email
Archiving The Royal Free has an archivist to provide advice and organise procedures for archiving of studies.
Contracts Research Contracts are managed within the Royal Free by a legally trained contracts team who review, draft and negotiate contracts and other agreements for all types of research studies, including international studies.
Research Management and Governance
The team provides advice on study approval processes, set up and governance arrangements for investigators and research teams within the Trust.
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Finance 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.
ATMP support Two ‘Advanced Therapy’ specialists are available to assist Principal Investigators with the regulatory requirements around ATMP trials.
[email protected] [email protected]
Services are provided in partnership with the UCL/UCLH/Royal Free Joint Research Office.
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ORGANISATION R&D INTERESTS Information on the research areas of interest to the organisation (provide detailed or summary information as appropriate). Organisation R&D areas of interest Area of interest Details Contact Amyloidosis and acute phase proteins
Diagnosis and evaluation of the extent of disease using whole body SAP scintigraphy
Histological review and immunohistochemistry to determine amyloid type
Characterisation and exclusion of hereditary amyloidosis and familial Mediterranean fever and other inherited periodic fever syndrome
DNA testing and analysis Genetic counselling Recommendations for treatment
(ranging from chemotherapy to organ transplantation)
Measurement/monthly monitoring of mailed blood samples of serum amyloid A protein
6-12 monthly follow-up to evaluate response and further treatment requirements
Provision of information and support to amyloidosis patients
Systematic evaluation of existing
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=254
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and new treatments
Cancer
Within cancer we have the interest and capabilities to run phase II through to phase III. All relevant anti-cancer treatment modalities are studied within Royal Free, including trials of IMPs, surgical techniques, radiotherapy and new/novel technologies and translational research studies. Links with UCL and the North London Cancer Research Network allow for a highly developed clinical trials programme. All tumour areas treated within the hospital undertake research activities with particular strengths being in haematology, lung, breast, colorectal, hepatobilary and urological cancers.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=238
Cardiology The cardiology department at the Royal Free Hospital provides a comprehensive patient-centred service with in-patient and out-patient facilities for investigation and treatment of heart problems. In addition to providing a general “secondary care” (hospital based) cardiology service for local patients, the trust also provides a range of “tertiary care” services (when a patient is referred from another hospital). These services require specialist expertise and consequently are only available in designated hospitals.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=156
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The trust is also one of two “heart attack centres” for the North Central London sector providing 24/7 emergency angioplasty treatment for patients presenting with acute myocardial infarction (heart attack). We also provide specialist services for primary and secondary prevention in cardiovascular risk management (care for patients at high risk of developing heart disease and treatment for patients who have established heart disease to prevent worsening of their condition); these services are nurse or physician-led.
Cellular Pathology The department of cellular pathology,
Royal Free London NHS Foundation Trust and University College London Medical School, is a combined trust and medical school department providing a comprehensive diagnostic service and a research facility. The department is part of the oncology directorate, part of the division of specialist services. The department processes approximately 20,000 histology, 130 autopsies and 5,000 diagnostic cytology specimens a year. Gynae cytology samples are reported by the joint Royal Free and
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=364
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UCLH Cervical Cytology Service which is based at UCLH. We hold full accreditation with Clinical Pathology Accreditation (CPA) UK Ltd.
Respiratory Medicine
The Department of Respiratory Medicine provides diagnostic and treatment services for a wide variety of respiratory illnesses. Our team includes specialist doctors, nurses, physiotherapists and scientists working with colleagues throughout the NHS.
http://www.royalfree.nhs.uk/resp.aspx?top_nav_id=1&tab_id=602
Child health Our network of care spans community, secondary and tertiary child health services. We are committed to working in partnership with other organisations to improve the health of local children.
http://www.royalfree.nhs.uk/child_services.aspx?top_nav_id=1&tab_id=927
Immunity, Infection and Transplantation
Research into vaccination, cell therapy and gene therapy for Cancer, Chronic Viral Infection, Autoimmune conditions, Immunodeficiency and Transplantation. 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
http://www.ucl.ac.uk/cancer/reshaematology/tumorimm
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programme. HIV, hospital acquired infections, imported infections, SLE, complications of autoimmune arthritis. Royal Free has a significant portfolio of NIHR and commercial clinical trials in the HIV setting. We are a leading recruiter for this type of study.
Haematology We can support studies in malignant and non-malignant Haematology. Malignant includes Lymphoma, Leukaemia, bone marrow transplant and myeloma. Non malignant mainly in haemophilia. We can support phase II-phase III trials involving IMPs both oral and systemic and in translational/genetic studies. Conditions- we have all the necessary laboratories, in-patient beds, outpatient clinics and a chemo suite to run the studies with a large research team of clinical research nurses, investigators and data managers.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=324
Haemophilia and Haemostasis
The Haemophilia centre provides the following services:
comprehensive care centre for patients with inherited and acquired bleeding disorders, including diagnosis and management
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=558
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thrombosis service for investigation and management of inherited and acquired thrombotic conditions, including a Level IV anticoagulation service
comprehensive laboratory services for the diagnosis and management of various inherited and acquired bleeding and thrombotic disorders, including genetic diagnosis
Head and neck Specialist clinics include:
Voice clinic with stroboscopy at Edgware Hospital.
Acoustic neuroma clinic at Royal free Hospital (held in conjunction with neurosurgeons and a radiotherapists).
Paediatric clinic at the Royal Free Hospital.
Thyroid oncology clinic at Royal Free Hospital.
Nurse-led clinics at Barnet General Hospital and Edgware Hospital.
Direct referral clinics for hearing aids at all sites.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=492
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Health care of elderly people
The department of health services for elderly people is a hospital based team which aims to provide the best diagnosis, treatment and care for all older people who present to the Royal Free Hospital. The unit has nine consultant geriatrician teams who work within multidisciplinary teams and are responsible for care of older people who have acute medical illness. They also provide a service to older patients who are under the care of non elderly specialist teams such as surgery to ensure they receive optimum care whilst undergoing specialist treatment. The department is currently developing pathways in partnership with primary care to provide outreach specialist advice to older people in the community.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=378
Liver and intestinal disorders
The Royal Free Sheila Sherlock Liver Centre has been established for over fifty years and is one of the country’s leading centres for the diagnosis and treatment of liver disease. The centre offers a fully integrated service, including acute liver disease and liver transplant, surgery and after care for liver and related cancers, alcohol and hepatitis services. Its highly
http://www.royalfree.nhs.uk/liver.aspx?top_nav_id=1&tab_id=701
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skilled team is committed to providing the best possible care to patients - combining a personalized and friendly approach with state-of-the art diagnostic and treatment tools. Research and innovation are central to the centre’s activities and the team works in close partnership with University College London, one of the ten leading research universities in the world to ensure that the centre remains at the cutting edge of research and development in this field.
Plastic and Reconstructive Surgery
Welcome to the department of plastic and reconstructive surgery. The service is based at the Royal Free Hospital and our team of fifteen consultants all undertake general plastic surgery procedures in addition to which they each have sub-specialty interests. These include the surgery for facial reanimation, ear reconstruction, hand conditions, the treatment and diagnosis of skin cancers including sentinel node biopsy in melanoma, breast surgery including reconstruction and treatment of lower limb trauma.
http://www.royalfree.nhs.uk/plastics.aspx?top_nav_id=1&tab_id=876
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Neurology As well as general Neurology clinics, there are specialist clinics at the Royal Free Hospital for:
Behçet’s disease Botulinum Cognitive neurology Epilepsy Headache management HIV neurology Motor neurone disease Multiple sclerosis Neuro-genetics Neuromuscular Neuro-ophthalmology Neurosarcoidosis Parkinson’s disease Peripheral neuropathy
http://www.royalfree.nhs.uk/neuro.aspx?top_nav_id=1&tab_id=734
Primary care and Public Health
The UCL School of Primary Care and Population Health, Royal Free Campus aims to deliver high quality teaching in community-based primary care and public health and to undertake a programme of internationally competitive multi-disciplinary research addressing the management and prevention of disease in individuals and populations in areas of priority to the health of the public.
http://www.ucl.ac.uk/pcph/
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Renal services and Urology
The Royal Free nephrology department serves patients with kidney disease in north central London (Camden, Islington, Barnet, Enfield and Haringey PCTs), providing comprehensive services in nephrology, transplantation, urology and dialysis. The department has:
A national reputation in the management for renal tubular disease, systemic vasculitis, renal bone disease, nephro-urology and renal transplantation.
Specialist clinical interests including dialysis, diabetic nephropathy, Chronic Kidney Disease (CKD) and cardiovascular risk, renal genetic disorders and HIV associated renal disease.
Expertise in the management of CKD, renal amyloidosis, scleroderma, lupus nephritis, hepatorenal syndrome and fabry disease.
And provides a full range of renal services:
Dialysis Chronic Kidney Disease (CKD)
http://www.royalfree.nhs.uk/renal.aspx?top_nav_id=1&tab_id=974
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In-patient services General nephrology Support services Renal transplantation Vascular access
Women’s health
Gynaecological cancer, Polycystic Ovary Syndrome, Vulval Disease, Colposcopy (including invasive cancers), Urogynaecology, Antenatal and Periopartum care.
http://www.royalfree.nhs.uk/default.aspx?top_nav_id=1&sel_left_nav=25&tab_id=473
INFORMATION ON LOCAL / NATIONAL SPECIALTY GROUP MEMBERSHIP WITHIN THE ORGANISATION WHICH HAS BEEN SHARED WITH THE CLRN. Specialty Group Membership (Local and National)
Royal Free has a close working relationship with the following networks North London Cancer Research Network Dementia and Neurodegenerative diseases – Dendron Stroke - Thames Stroke Network
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RFH is actively involved in the following networks
NCRI High Grade Lymphoma Clinical Studies Group NCRI Haematological Oncology Clinical Studies Group NCRI Adult ALL Sub-group NCRI AML Sub-group British Society of Blood and Marrow Transplantation NCRN Low Grade Lymphoma Group BCSH Adult Haematology / ICU Guidelines Group NIHR Health Technology Assessment Panel Respiratory Anaesthetics Cardiovascular Critical Care ENT Gastrointestinal Hepatology Immunology and Inflammation Infectious diseases and Microbiology Metabolic and Endocrine Musculoskeletal Nervous system disorders Non malignant Haematology Ophthalmology Paediatrics Public Health Research Renal Reproductive Health and Childbirth Respiratory Surgery Urogenital
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ORGANISATION R&D PLANNING AND INVESTMENT Local funds have been invested into the following schemes:
Consultant Research PA Scheme Research Nurse PA Scheme
ORGANISATION R&D STANDARD OPERATING PROCEDURE REGISTER
SOP Ref Number SOP Title
JRO RFH INV SOP 1 SOP for SuSAR and serious breaches recording and reporting for CTIMPs hosted in the Trust
JRO RMG RSS SOP 1 SOP on the development RMG RSS SOPs JRO RMG RSS SOP 2 Sponsorship of "simple" studies JRO RMG RSS SOP 3 Sponsorship of "complex" studies JRO RMG RSS SOP 4 Arrangements for assessing study feasibility JRO RMG RSS SOP 5 NHS permissions JRO RMG RSS SOP 6 Set up and control of external agreements JRO RMG RSS SOP 7 Honorary contracts and letters of access JRO RMG RSS SOP 8 Procedure for study amendments JRO RMG RSS SOP 9 Reporting and escalation of study events and incidents JRO RMG RSS SOP 10 R and D systems events JRO RMG RSS SOP 11 Audit and monitoring JRO RMG RSS SOP 12 Study closure - notification and archiving JRO RMG RSS SOP 13 Requirements for site file JRO RMG RSS SOP 14 Partner and member level responsibilities JRO RMG RSS SOP 15 Handling study events
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INFORMATION ON THE PROCESSES USED FOR MANAGING RESEARCH PASSPORTS Where staff do not have substantive or honorary employment contracts with the Trust, the Senior Research Administrator or Research Network Co-ordinator will notify researchers of the need for a research passport, where that is appropriate. The process is overseen by Alka Mistry ([email protected]) on behalf of the Joint Research Office. There are separate processes for NHS – NHS letters of access and for the provision of honorary employment contracts to university staff. The process is summarised below:
NHS-NHS Letter of Access: SRAs/RNC to send out requests to other HR departments for NHS proformas. Email UCLH supervisor to confirm they have knowledge of the researcher and they agree to take day-to-day responsibility
for them. No other docs needed as the signed proforma from HR indicates all checks have been completed by substantive employer. Once proforma and supervisors confirmation received, Administrator can issue the Letter of Access. 3 copies: 1 for researcher, 1 for R&D department and 1 for substantive employer – post to HR dept.
University Staff – Honorary Research Contracts
SRA/RNC to decide if HRC or LoA are required dependent upon type of study
Researcher signposted to UCL web site – research passport section – download application form Form completed by researcher, line manager and devolved UCL HR sign off Completed form returned to R&D administrator Administrator checks that all sections are complete and all documents have been checked by University HR Section 8 – to be completed by Administrator and signed by Administrator. Email UCLH supervisor to confirm they have knowledge of the researcher and they agree to take day-to-day responsibility
for them Take copies of CRB – dated within the last 6months. Take copies of OH check. CV Passport – for ID purposes. Once RP form and supervisors confirmation received, inform SRA or RNC that Honorary Research Contract or LoA ready to
be issued – is Governance Approval ready as well. Issue Contract and Approval together. 3 copies of contract or LoA: 1 for researcher, 1 for R&D department and 1 for substantive employer – post to HR dept.
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Each HRC or LoA must have the UCL covering letter attached to explain differences in the passport application form which has been adapted due to the delegation of HR duties in UCL.
INFORMATION ON THE AGREED ESCALATION PROCESS TO BE USED WHEN R&D GOVERNANCE ISSUES CANNOT BE RESOLVED THROUGH NORMAL PROCESSES Escalation would be to the R&D Director for the clinical division related to the study / trial. PLANNED AND ACTUAL STUDIES REGISTER The Royal Free research portfolio is maintained on the ReDA database. The Trust approves around 100 studies every year, of which 35% are CTIMPs. Approximately 630 studies are actively recruiting at Royal Free, including 220 CTIMPs (35%) . Further information about the Royal Free portfolio can be obtained from [email protected] OTHER INFORMATION The number of patients receiving NHS services provided or subcontracted by the Royal Free London NHS Foundation Trust in 2011/12 that were recruited during that period to participate in research approved by a research ethics committee was 6654. This figure was a substantial increase over the previous year.