NIHR Guideline B01 R&D Operational Capability Statement Sep-14

Transcription

1 NIHR Guideline B01 R&D Operational Capability Statement Sep-14 Note: This spreadsheet is protected to help avoid inadvertent changes. However there is no password set so that users can unlock the sheet and edit their own content if required. Version History Version number Valid from Valid to Date approved Approved by Updated by Statement /10/ /03/2015 Peter Maskell Peter Maskell 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 information 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) R&D office details: Name: Address: : Contact Other relevant information: Kent Community Health NHS Trust Dr Peter Maskell Dawn Nortman Trinity House, Upper Pemberton, Eureka Business Park, Ashford, Kent TN25 4AZ dawn.nortman@kentcht.nhs.uk Head of Clinical Audit & Research Key contact details e.g. Research governance lead, NHS Permissions signatory contact details Contact 1: Role: Research Management and Governance Manager for RM&G Consortium for Kent and Medway Name: Richard Collins : Contact rmgconsortium@nhs.net Contact 2: Role: RM&G Facilitator Name: Jane Field : Contact rmgconsortium@nhs.net Contact 3: Role: Senior Research Nurse Name: Lee Tomlinson : or Contact lee.tomlinson@kentcht.nhs.uk Add further contacts by selecting and then copying the five Excel rows (i.e. whole rows) above for Contact, role, name, number and . Then select the blank row under the table and 'insert copied cells'. (Please do not select and copy individual cells or groups of cells as this does not preserve formatting.) Page 1 of 8

2 Information on staffing of the R&D office. R&D team R&D office roles (e.g. Governance, contracts, etc) Whole time equivalent B8b Head of Clinical Audit & Research 0.5 B7 Senior Research Nurse 0.4 B6 Research Nurse 1 B3 Administrator 0.26 Comments indicate if shared/joint/week days in office etc Works Mondays & Thursdays Works Monday, Tuesday, Thursday & Friday Information on reporting structure in organisation (include information on any relevant committees, for example, a clinical research board / research committee / steering committee). Reporting structures The Research & Development Committee (RDC) of Kent Community Health NHS Trust is a committee set up by the Trust to oversee all matters connected with research and development. Its remit includes overseeing the process of research governance, ensuring quality, taking steps to improve the profile of R&D inside the Trust and promoting new initiatives to promote new research in its area. Its purpose is to develop, deliver and embed the Trust's research strategy by actively engaging and enabling KCHT staff to particpate in and lead research. The RDC reports to the Quality Committee which in turn reports to the Board. Information on research networks supporting/working with the organisation. Information on how the organisation works with the Comprehensive Local Research Network (CLRN), Primary Care Research Network (PCRN), Topic Specific Clinical Research Networks (TCRN). Research networks Research network (name/location) Role/relationship of the research network e.g. host organisation CRN Kent Surrey and Sussex Palliative Care Forum Dementia Research Forum CRN: Kent Surrey and Sussex provide research infrastructure to support delivery of NIHR Portfolio Studies and to develop capacity and capability in the area. The CRN supports research activity in primary, secondary and tertiary care, mental health services and emergency services. RM&G services are provided by the central RM&G Consortium for Kent and Medway based at Gillingham Business Park. In addition, the CRN provides service support costs, capacity development funds and incentives to encourage and facilitate NHIR Portfolio research. Information on collaborations and partnerships for research activity (e.g. Biomedical Research Centre/Unit, 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 address Page 2 of 8

3 University of Kent Canterbury Christ Church University University of Greenwich Kent County Council Social Services Research Team Research Design Service Heart of Kent Hospice KentHealth is the University of Kent s onestop-shop for health and social care expertise in research, training, innovation and partnerships with the regional NHS. A key aim is to bring the region s healthcare Peter Nichols agencies together and is committed to Julie Hedayioglu promoting, and increasing the amount of, collaborative research done between University academics and their healthcare colleagues With Health and Wellbeing as focus for the Faculty, research undertaken is Prof Doug MacInnes, Professor of Mental person-centred, and service-based as well Health as research to enhance professions Esther Coren, Faculty RKE Lead practice and evidence base Centre for positive ageing currently collaborating on pain and dementia projects Professor Pat Schofield P.A.Schofield@Greenwich.ac.uk Collaboration in areas of Public Health and Sue Williams Health & Social Care sue.williams@kent.gov.uk Sited at University of Kent at Canterbury, provides help for those applying for grants Domino Moore d.moore@brighton.ac.uk for portfolio studies Andrew Thorns Charlotte Brigden p.nichols@kent.ac.uk J.A.Hedayioglu@kent.ac.uk douglas.macinnes@canterbury.ac.uk esther.coren@canterbury.ac.uk NHS England NHS England commissions services and potentially research projects from KCHT Dr James Thallon james.thallon@nhs.net East Kent Hospitals University NHS Foundation Trust (EKHUFT) EKHUFT is the local acute trust. KCHT refers patients to their trials and receives patients on the post-acute phase of their trials. There is also a collaboration on assistive technologies Dr Mo Sakel msakel@nhs.net University of East Anglia Dementia and delirium research, hospital care and prevention of dementia Dr Chris Fox chris.fox@uea.ac.uk Page 3 of 8

4 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) CTIMPs (indicate phases) Clinical trial of a medical device Other clinical studies Human tissue: Tissue samples studies As sponsoring organisation As participating organisation As participant identification centre Study administering questionnaires Qualitative study N N N N N N N Y Y N Y Y Y Y Y Y Y Y OTHER The Trust has plans to become a sponsor for studies in 2015 Information on any licences held by the organisation which may be relevant to research. Organisation licences Licence name Example: Human Tissue Authority licence There are no such licences (e.g. tissue bank) held by the Trust Licence details Licence start date (if applicable) Licence end date (if applicable) For organisations with responsibilities for GPs: Information on the practices which are able to conduct research. Number/notes on General Practitioner (GP) practices Trust no longer includes GPs Page 4 of 8

5 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 Specialist facilities that may be provided (e.g. number/type of scanners) Contact name within Contact service department Pathology Radiology Pharmacy Details of any internal agreement templates and other comments Currently KCHT does not posess "service departments" of this type. It has access to all these services through East Kent Hospitals Trust and other healthcare service providers if required for a research project. 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 name within Contact service department Archiving Contracts Legal Data management support Information Technology HR Statistical support Training Finance The Trust provides an archiving service through TNT The Trust provides advice, guidance and support throughout the contracting process The Legal Team is responsible for providing comprehensive legal support and guidance across the Trust The Consortium will provide the appropriate contacts to meet the study needs The Consortium handles all aspects of research passports etc (see below) No service is supplied but researchers can be put in contact with statisticians at the design stage of the project The CRN provides GCP Training, Introduction to RM&G training and Informed consent The Trust provides advice and management of R&D funds Christine Legister Christine.Legister@kentcht.nhs.uk Laura Dunmore laura.dunmore@kentcht.nhs.uk Sarah Costeloe Hazel Crawford Ruth Hulbert kcht.archiving@nhs.net Richard Collins rmgconsortium.km@nhs.net sarah.costeloe@nihr.ac.uk hazel.whalley-crawford@nihr.ac.uk ruth.hulbert@nihr.ac.uk Shelley Deakin shelley.deakin@kentcht.nhs.uk Details of any internal agreement templates and other comments Page 5 of 8

6 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 Stroke Rehabilitation Tissue Viability Nutritionn Chronic Pain Details Contact name Contact Dental Studies Please contact R&D Office. Contact details given previously. Dementia End of Life Podiatry Long Term Conditions Information 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 Contact name group) Contact Local Age and Ageing Sue Williams sue.williams@kent.gov.uk Local Centre of Positive Ageing Professor Pat P.A.Schofield@Greenwich.ac.uk Schofield Organisation R&D planning and investments Planned investment Area of investment (e.g. Facilities, training, recruitment, equipment etc.) Training and recruitment Research Training Description of planned investment Planned investment by CRN to support training and recruitment and to deliver sufficient training for all research active facilities to improve local research activity and involvement The Trust are planning to run the following events in Research Into Practice, Funding Workshop, Literature Searching Skills and Inroduction to Critical Appraisal Skills (Qualitative) Value of investment Indicative dates Continuing Continuing Page 6 of 8

7 Organisation R&D standard operating procedures register Standard operating procedures SOP ref number SOP title SOP details Valid from The RM&G Consortium for Kent and Medway have a suite of standard operating procedures which cover research governance for the Trust. Valid to Information on the processes used for managing research passports. Indicate what processes are used for managing research passports The process is delegated to the RM&G Consortium for Kent and Medway who carry out all the relevant checks and provide advice to applicants. The office will issue Letters of Access or Honorary Research Contracts as appropriate and inform the Trust HR (recruitment) and the HR Departement of the substantive employers of their issue. The process involves ensuring an appropriate supervisor in the Trust has been named and is appointed. Information on the agreed escalation process to be used when R&D governance issues cannot be resolved through normal processes. Escalation process Issues are usually resolved by the RM&G Consortium for Kent and Medway in discussion with the PI or CI or Lead CRN or the sponsor, taking advice from Trust personnel where appropriate. When issues are resolved, or if they have been resolved as far as possible, the R&D Manager will be consulted to make a decision on whether the Trust wishes to participate in a particular project. This will be done in consultation with the Medicines Manager or other appropriate specialists in the Trust. Only if the issue cannot be resolved and a policy decision is required will the matter be referred to the Committee structure (see above) and eventually Board level for decision. Issues relating to the performance of the RM&G Consortium for Kent and Medway can be escalated to the RM&D Lead for CRN: Kent, Surrey and Sussex who will investigate in conjunction with both the site NHS organisation (KCHT) and the sponsor organisation. Page 7 of 8

8 Planned and actual studies register The organisation should maintain or have access to a current list of planned and actual studies which its staff lead or in which they are involved. Comments Studies are recorded on a local database which is also used to monitor progress. Details of governance procedures for portolio studies are managed on the CSP module. The organisation also maintains an internal activity register. This keeps a record of studies being undertaken which includes audits and service evaluations. Other information For example, where information can be found about the publications and other outcomes of research which key staff have led or have otherwise contributed. Other information (relevant to the capability of the organisation) KCHT is working with CCG's to promote research more broadly. Page 8 of 8