NIHR Guideline B01 R&D Operational Capability Statement

Transcription

1 NIHR Guideline B01 R&D Operational Capability Statement Version Histy Version number Valid from Valid to Date approved Approved by To be Updated by RDOCS /04/ /03/2011 Trust Board Diana Hardy RDOCS /03/2013 Contents Organisation R&D Management Arrangements Organisation Study Capabilities Organisation Services Organisation R&D Interests Organisation R&D Planning and Investments Organisation R&D Standard Operating Procedures Register Planned and Actual Studies Register Other Infmation Organisation R&D Management Arrangements Infmation on key contacts Organisation Details Name of Organisation Luton and Dunstable Hospital NHS Foundation Trust R&D Lead / Direct (with responsibility f repting on R&D to the Organisation Board) Dr. Christopher M. Travill (Direct of Research and Development) and Dr. Mark Patten (Medical Direct) Key Contact Details e.g. Research Governance Lead, NHS Permissions Signaty contact details Contact 1: Role: Name: Contact Number: Contact Research & Development Manager (Trust Research Management & Governance [RM&G] Lead) - primary point of contact f research enquiries Diana Hardy Contact 2: Role: Name: Contact Number: NHS Permission and Clinical Trial Agreement signaty, Direct of Research & Development Dr. Christopher M. Travill Contact christopher.travill@ldh.nhs.uk Infmation on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) Whole Time Equivalent R&D Manager 1 R&D Administrat 0.54 Data Management 1 Commments indicate if part time/full time/shared/joint etc Service across the Trust f NIHR Ptfolio and non-nihr research studies Service across the Trust f NIHR Ptfolio and non-nihr research studies Service across the Trust f NIHR Ptfolio and non-nihr research studies

2 Infmation on repting structure in ganisation (include infmation on any relevant committees, f example, a Clinical Research Board / Research Committee / Steering Committee.) Repting Structures Line of Accountability: The R & D Direct is accountable to the Chief Executive and the Medical Direct. The R & D Manager is accountable to the Chief Executive and repts to the R & D Direct. The R & D Direct is a member of the Trust's Medical Divisional Board, Clinical Directs' Meetings and the Clinical Audit and Effectiveness Committee. The R & D Manager is also a member of the Clinical Audit and Effectiveness Committee. Both the R&D Direct and R&D Manager are members of the Division of Medical Education and Research (DMER) Committee which repts to the Executive Board who in turn repts to the Trust Board. The DMER Committee also repts to the Clinical Operational Board who repts to the Trust Board. The R & D Administrat and the Data Management officer are accountable to the R & D Direct and rept to the R & D Manager. Infmation on Research Netwks suppting/wking with the Organisation. Infmation on how the Organisation wks with the Comprehensive Local Research Netwk (CLRN), Primary Care Research Netwk (PCRN), Topic Specific Clinical Research Netwks (TCRN) Research Netwks Research Netwk (name/location) Role/relationship of the Research Netwk eg host Organisation West Anglia CLRN (Cambridge University Hospitals NHS Member. The R & D Direct is an Executive Member of the West Anglia CLRN Executive Group and Member of the West Anglia CLRN Board Foundation Trust) National Cancer Research Netwk (Mount Vernon) Host Netwk studies Stroke (Trent) Host Netwk studies DenDRoN (Nth Thames) Host Netwk studies Infmation on collabations and partnerships f research activity (e.g. BRC, BRU, Other NHS Organisations, Higher Education Institutes, Industry) Current Collabations / Partnerships Details of Collabation / Partnership (eg Organisation Name University/Organisation Joint Office, external provider of pathology services to Organisation, etc, Contact Name effective dates) Health Enterprise East Research Design Services [RDS], East of England University of Bedfdshire Service Level Agreement f innovation Access to RDS services Stuart Thomson Suzanne Murphy / Ron Driver suzanne.murphy@beds.ac.uk / ron.driver@beds.ac.uk Collabation Profess Alan Sinclair alan.sinclair@beds.ac.uk address stuart.thomson@hee.g.uk Contact Number / / University of Hertfdshire Collabation Dr. Mark Alexander mark.alexander@ldh.nhs.uk

3 Organisation Study Capabilities Infmation on the types of studies that can be suppted by the Organisation to the relevant regulaty standards Types of Studies Organisation has capabilities in (please tick applicable) CTIMPs Clinical Trial of a Medical Other Clinical Studies (indicate Phases) Device As Sponsing Organisation Human Tissue: Tissue Samples Studies Study Administering Questionnaires No No Yes * No Yes * Yes * Qualitative Study OTHER * Sponsship of 'Own Account' studies only. However, we may consider NIHR NIHR-partner funded studies undertaken by Luton and Dunstable Hospital (L&D) staff and to take place only on the L & D site. Any queries - contact the R & D Department. Refer to R&D SOP2. As Participating Organisation As Participant Identification Centre Yes (Phase II - IV) Yes Yes Yes Yes Yes Yes (Phase II - IV) Yes Yes Yes Yes Yes Considered on application to R & D Department Considered on application to R & D Department Which licences does the ganisation hold which may be relevant to research? Organisation Licences Licence Name Example: Human Tissue Authity Licence Licence Details Licence Start Date (if applicable) Licence End Date (if applicable) None f research PCT ONLY: Infmation on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices

4 Organisation Services Infmation on key clinical services contacts and facilities/equipment which may be used in studies f supting R&D governance decisions across the ganisation. Clinical Service Departments Service Department Pathology Specialist facilities that may be provided (eg number/type of scanners) Biochemistry, Histopathology, Chemical Pathology, Microbiology, Virology, Heamatology Contact Name within Service Department Contact via R & D Office in the first : Contact number Details of any internal agreement templates Imaging / Radiology X-Ray, Ultrasound, MRI scan, CT scan, DEXA scanning via R & D Office in the first : Pharmacy All pharmacy services excluding manufacturing via R & D Office in the first : Nuclear Medicine Cardiology Neurophysiology Comprehensie Nuclear Medicine facilities ECG, Treadmill/Exercise Testing (ETT), Echos, 24 hour taping EEG, sleep EEG, EMG, Needle EMG, VEP, Nerve Conduction study via R & D Office in the first : via R & D Office in the first : via R & D Office in the first : Lung Function Labaty Lung function tests including spirometry, Buddy Box, gas transfer, walking tests, PH manometry and oesophageal manometry, sleep study via R & D Office in the first : Bariatric Services Comprehensive Bariatric Services facilities via R & D Office in the first : Infmation on key management contacts f supting R&D governance decisions across the ganisation. Management Suppt e.g. Finance, Legal Services, Archiving Department Specialist services that may be provided Archiving the Trust's IM&T Project Manager Contact Name within Service Department Diana Hardy Linda Watts Contact linda.watts@ldh.nhs.uk Contact number Details of any internal agreement templates Contracts Diana Hardy Data management suppt Diana Hardy Finance Infmation Technology Legal Diana Hardy Jenny Wills Diana Hardy Carleton Keddo Diana Hardy Human Resources Diana Hardy Caldicott Guardian Diana Hardy Data Protection Diana Hardy Gayn Flynn NIHR Research Design Service, East of England Expert advice on accessing the services of this suzanne murphy suzanne.murphy@beds.ac.uk external ganisation Trust Financial Controller IT Security Manager. Trust Legal Department can be approached as required f exceptional legal queries IG Manager & Interim Data Protection & FOI Manager jenny.wills@ldh.nhs.uk carleton.keddo@ldh.nhs.uk gayn.flynn@ldh.nhs.uk

5 Organisation R&D Interests Infmation on the areas of research interest to the Organisation Organisation R&D Areas of Interest Area of Interest Details Contact Name Contact Contact Number Cancer Oncology research covers seven tumour sites: Dr. Mei-Lin Ah-See, Dr. Kate Goodchild, breast, lung, colectal, haematology, urology, Profess Peter Hoskin, Dr. Suzannah Mawdsley upper gastrointestinal and head and neck. (Consultant Oncologists); Dr. Sanjit Fla, Dr. Ching-Wai Cheung, Dr. Rahul Joshi (Consultant Haematologists); Dr. Matthew Johnson (Consultant Gastroenterologist); Mr. Duraissmy Ravichandran, Miss Marion Obichere (Consultant Surgeons); Mr. Chi-Hwa Chan (Consultant Maxillo-Facial Surgeon and Lead Clinician f Cancer Services); Dementia, Multiple Sclerosis and Neurodegenerative Disders Dr. Anette Schrag, Dr. Paul Watts, Dr. Andrew karen.lithgo@ldh.nhs.uk dementia, neurological and neurodegenerative Gale, Dr. Linda Parsons disders Stroke stroke Dr. Lakshmanan Sekaran frances.justin@ldh.nhs.uk margaret.tate@ldh.nhs.uk Bariatric Services Lynsey Doyle lynsey.doyle@ldh.nhs.uk bariatric services Cardiology heart disease. This will be enhanced when the new Cardiac Catheterisation Suite is opened later in Dr. Christopher M. Travill susan.gent@ldh.nhs.uk / Endocrinology Comprehensive endocrinology service Dr. Ritwik Banerjee ritwik.banerjee@ldh.nhs.uk Hepatology Comprehensive hepatology service Dr. Sambit Sen sambit.sen@ldh.nhs.uk NICU Orthopaedics Neonatal Medicine. trauma and thopaedic services Dr. Anusha Arasu Dr. Claudia Chetcuti-Ganado Dr. Shanthi Shanmugalingam Dr. Sarah Skinner Dr. Sateesh Somisetty Mr. Yegappan Kalairajah yvonne.millar@ldh.nhs.uk jenny.baker@ldh.nhs.uk yegappan.kalairajah@ldh.nhs.uk Paediatrics Paediatric services. Dr. Michael Eisenhut Dr. Nisha Nathwani Dr. Tekki Sreenivasa Rao karen.reep@ldh.nhs.uk The Trust will consider undertaking research in all areas where we have service delivery and adequate suppt and facilities are available Diana Hardy Infmation on Local / National Specialty group membership within the Organisation which has been shared with the CLRN Specialty Group Membership (Local and National) National / Local Specialty Group Specialty Area (if only specific areas within group) Contact Name Contact Contact Number West Anglia CLRN Clinical Lead f STROKE research Stroke Dr. Lakshmanan Sekaran lakshmanan.sekaran@ldh.nhs.uk West Anglia CLRN Local Clinical Lead Cardiology Dr. Christopher Travill christopher.travill@ldh.nhs.uk West Anglia CLRN Local Clinical Lead Ear, Nose and Throat (ENT) Ms. Jaan Panesar jaan.panesar@ldh.nhs.uk

6 Organisation R&D Planning and Investments Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Description of Planned Investment Value of Investment Indicative dates Investment via West Anglia CLRN Programmed Activities f consultant researchers and research nurse suppt funding Annually allocated, dependent on activity. In 2011/12, the Trust received 381,575 from West Anglia CLRN From 2008/09 to ongoing Investment via NCRN (Mount Vernon) Research Nurse suppt funding The Trust is annually allocated funding f 1 wte Band 7 Oncology Research Nurse From 2003/04 to ongoing

7 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details Valid from Valid to R&D SOP1 Acronyms R&D SOP2 Study Start Up R&D SOP3 Study Initiation R&D SOP4 Preparation of SOPs R&D SOP5 Responsibilities R&D SOP6 Training R&D SOP7 Study Files and Filing R&D SOP8 Infmed Consent R&D SOP9 CRF Completion R&D SOP10 Amendments to Research Studies R&D SOP11 Safety Repting R&D SOP12 Moniting Visit R&D SOP13 Audit and Inspection R&D SOP14 Archiving and Destroying Documents R&D SOP15 Code Break - Emergency Unblinding Procedures Pharmacy SOP Procedure f Pharmacy Suppt of Clinical Trials (Version 4) 02/05/ /05/2014 Honary Research Contracts Policy Honary Research Contracts Policy As outlined in Policy Title 01/03/ /03/2013 Research & Development Strategy R&D Strategy Outlines the Trust's R & D Strategy 01/03/ /03/2016 Intellectual Property Policy Intellectual Property Policy Outlines the Trust's Intellectual Property Policy 30/10/ /10/2015 Infmation on the processes used f managing Research Passpts Indicate what processes are used f managing Research Passpts NIHR Research Passpt process facilitated via the R & D Office using the NIHR Research in the NHS: HR Good Practice Resource Pack ( ) f both ptfolio and non-ptfolio studies. The Trust Board has approved Honary Research Contracts Policy. Infmation on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through nmal processes Escalation Process Escalated from R&D Manager to R & D Direct. Further escalation would be to Medical Direct then Trust Board.

8 Planned and Actual Studies Register The R&D Department maintains a database (ReDA) of all research projects it approves to take place at the Trust. If you require further infmation please contact the R & D Department. Other Infmation F example, where can infmation be found about the publications and other outcomes of research which key staff led callabated in? Other Infmation (relevant to the capability of the Organisation) The Luton and Dunstable Hospital NHS Foundation Trust is a member of West Anglia Comprehensive Local Research Netwk (CLRN). The majity of our research funding is provided by that CLRN in der to suppt NIHR ptfolio studies. This funding provides f the appointment of a clinical research fellow, research nurses, research data officers, pharmacy and pathology technicians, Research Facilitat (externally funded by West Anglia CLRN but based at the L&D) etc. The L & D also benefits from Research Management and Governance (RM&G) funding via West Anglia CLRN. This enables the R & D Department to provide full suppt f the Trust's researchers in relation to their NIHR Co-Ordinated System f NHS Permission (ie. R&D and REC approvals which is a mandaty and legal process); research passpts f external personnel; research suppt services (ie. to suppt research and researchers thoughout the duration of their research at the Trust. This includes suppt to the associated departments of the research such as Pharmacy, Pathology, Radiology, Finance, etc.). Links via West Anglia CLRN also provide Good Clinical Practice (GCP) training which is a mandaty requirement f researchers taking part in research. We have links with the National Cancer Research Netwk (Mount Vernon) and funding from that ganistion provides f the appointment of a research nurse. West Anglia CLRN has provided funding f an additional cancer research nurse. The Trust is a research active ganisation with research being undertaken in many disease areas e.g. cancer, stroke, NICU (one of the L&D's key specialties offering Level 3 [the highest level] intensive care f premature and vulnerable babies needing extra care), paediatrics, neurology, cardiology, thopaedics, anaesthesia, al and maxillo-facial surgery (cancer), rheumatology, haematology, GUM. However, not only would we look to increase capacity in these areas but to increase capacity in the potential growth areas such as diabetes, dermatology, respiraty medicine, gastroenterology, urology, O&G, ENT, ageing and bariatric services, etc. The Luton and Dunstable Hospital is currently one of two specialist bariatric centres accredited by the NHS to provide weight loss surgery throughout the East of England region. Patients are also referred from within the Thames Valley region (Buckinghamshire, Milton Keynes and Oxfdshire) and Nthamptonshire. Increasing research capacity would greatly enhance the strengths of the Trust since research provides the evidence that contributes to patient safety whilst providing a gold standard reference. The avenues of infming researchers and all other staff of the research which is ongoing at the Trust is via the R&D Departrment, the Trust's annual R&D Academic Rept and R&D Newsletter.