Research & Development Operational Capability Statement (RDOCS) Report written by:

Transcription

1 4.3 Report to: Board of Directors Date of Meeting: 27 August 2015 Section: Strategy Report title: Research & Development Operational Capability Statement (RDOCS) Report written by: Dianne Tetley Job title: Assistant Director Research, Innovation & Effectiveness Lead officer: Dr Sue Elcock, Medical Director Board Action Required: Decision For Assurance (Yes or No): Yes Purpose of the Report The LPFT R&D Operational Capability Statement (RDOCS) needs to be approved annually by the LPFT Board of Directors. It is a requirement of the National Institute for Health Research (NIHR) that all research active NHS Trusts have an RDOCS in place. The LPFT RDOCS gives an overview of the research capabilities of LPFT, including the Trust s areas of research interest and other facilities available at LPFT and the Trust s research partnerships. An annual report required to be approved. Key Issues, Options and Risks Executive Analysis Our research department not only makes a significant contribution to the high level research projects nationally but also embeds a culture of research and innovation within LPFT. It also enhances LPFT activity portfolio and is a valuable addition to our funding streams. The research department brings in a valuable financial contribution. LPFT continue to feature strongly as an active research centre in the region and nationally. Our RDOCS submission indicates our research capability which is significant for the size and capacity of LPFT. The Board is requested to approve this and consider how to promote the research activity more widely with our external stakeholders. Recommendation (action required, by whom, by when) Board review and approval of content. CQC Standards Impacted: Financial Implications: Equality Analysis: Compliance Impact: N/A N/A N/A N/A The content of this report is the property of Lincolnshire Partnership NHS Foundation Trust Document Control - Version 2 2 April 2015 Page 1 of 10

2 NIHR Guideline B01 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCS Trust Board Dianne Tetley RDOCS Trust Board Tracy McCranor RDOCS Trust Board Tracy McCranor RDOCS Trust Board Tracy McCranor 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 Lincolnshire Partnership NHS Foundation Trust (LPFT) Dianne Tetley, Assistant Director Research, Innovation and Effectiveness Page 2 of 10

3 Name Research, Innovation and Effectiveness Department Address Learning and Development Centre, Unit 3, the Reservation, East Road, Sleaford, Lincolnshire, NG34 7BY Contact Number Contact Other relevant information Dr Sue Elcock, Medical Director, holds Corporate responsibility for R&D Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: Assistant Director Research, Innovation and Effectiveness; Research Governance Lead; NHS Permissions Signatory Name: Dianne Tetley Contact Number: Contact Contact 2: Role: Research Coordinator/Lead Clinical Studies Officer (deputy signatory in the absence of Assistant Director Research, Innovation and Effectiveness) Name: Tracy McCranor Contact Number: Contact Contact 3: Role: Chief Pharmacist; additional signatory for CTIMP NHS permission only Name: Shiraz Haider Contact Number: Contact Contact 4: Role: Name: Contact Number: Contact Contact 5: Role: Page 3 of 10

4 Name: Contact Number: Contact Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc.) Assistant Director Research, Innovation and Whole Time Equivalent Comments Indicate if shared/joint/week days in the office 1 Director responsibility for R&D, Innovation and Clinical Effectiveness Effectiveness Research Coordinator/RM&G Lead 1 Lead Clinical Studies Officer and co-ordinator Research and Audit Assistant 0.5 Time split equally between research governance and clinical audit Information on reporting structure in organisation (include information on any relevant committees, for examples, a Clinical Research Board/Research Committee/Steering Committee.) Reporting Structures The Assistant Director of Research, Innovation and Effectiveness is responsible directly to the Medical Director and the Trust Board. The Trust is a partner organisation of the Clinical Research Network: East Midlands (CRN: EM). R&D processes within LPFT have been streamlined to ensure timely permissions are granted to researchers in line with NIHR key performance indicators. 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) NIHR Clinical Research Network: East Midlands (CRN: EM) NIHR Research Design Service: East Midlands Role/relationship of the Research Network eg host Organisation Funding of research staff; national research performance and delivery; research governance and management via CSP also advise on local NIHR research applications Support the development of grant applications and research design Page 4 of 10

5 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 Contact Name Address Contact Number East Midlands Clinical Research Network (EM CRN) University of Lincoln Division 4 (Mental Health) Karen Pearson Karen.pearson@nihr.ac.uk Research partnership agreement and represent LPFT at Lincoln Institute for Health Steering Group Organisation Study Capabilities Professor Sara Owen Page 5 of 10 sowen@lincoln.ac.uk 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 CTIMPs (indicate Phases) Clinical Trial of a Medical Device Other Clinical Studies Human Tissue: Tissue Samples Studies Study Administering Questionnaires As Sponsoring phase 2,3 Organisation or 4 As Participating phase 2,3 Organisation As Participant Identification Centre or 4 phase 2,3 or 4 Qualitative Study Other Evaluation Studies Evaluation Studies Evaluation Studies Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Example: Human Tissue Authority Licence Details Licence Start Date (if applicable) Licence End Date (if applicable)

6 Licence ReDA (Research Database Application) web-based research management tool Designated and specialist research management database used by LPFT 2011 PCT ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices N/A Organisation Services Information on key clinical services contacts and facilitates/equipment which may be used in studies for supporting R&D governance decisions across the organisation. Clinical Service Departments Service Department Pharmacy All other service departments/facilities/equipment Specialist facilities that may be provided (eg number/type of scanners) Chief Pharmacist All facilities required for the facilitation of clinical trials Contact Name within Service Department Contact Contact Number Shiraz Haider Research Via R&D in the first instance Coordinator Details of any internal agreement templates and other comments Clinical trials pharmacy Page 6 of 10

7 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 Service Department Contact Contact number Archiving Carol Beattie Contracts Tracy McCranor Finance Costing of research/activity/proposals and R&D Finances Ruth Kisby R&D Approvals Tracy McCranor Approvals involving CTIMPs (additional approval) Chief Pharmacist, Shiraz Haider Industry costing template Tracy McCranor Details of any internal agreement templates and other comments Information on the areas of research interest to the Organisation Organisation R&D Areas of Interest Area of Interest Details Contact Name Contact Contact Number General adult services: - Acute care Acute inpatient care Community mental health service teams Crisis resolution & home treatment In-reach service Memory assessment Older Adult and dementia care Recovery All NIHR portfolio studies LPFT Clinical Studies Officer/Research Nurse team Page 7 of 10

8 Social day care Psychological therapies & primary care Adult mental health Bulimia nervosa service Chaplaincy services Child, adolescent & family Chronic fatigue syndrome Complex mental health & psychosis Dynamic psychotherapy Forensic Learning disability- Neuropsychology Personality Disorder Child & adolescent mental health services: - Community teams Inpatient, outreach & day care Children Looked After service Primary mental health service Youth offending service nurse specialists Specialist Services: - Assertive outreach Early intervention in psychosis (STEP) Anorexia Nervosa service Forensic services Learning disabilities Personality disorders Prison healthcare service Rehabilitation Drug & alcohol service Team Working and Organisational Working, Innovation and Evaluation All NIHR portfolio studies relating to NHS Trusts LPFT Clinical Studies Officer/Research nurse team All NIHR portfolio studies LPFT Clinical Studies/Research Nurse team All NIHR portfolio studies LPFT Clinical Studies/Research Nurse team All NIHR portfolio studies LPFT Clinical Studies/Research Nurse team INDUSTRY All NIHR portfolio studies LPFT Clinical Studies/Research Nurse team Page 8 of 10

9 Information on Local/National Speciality group membership within the Organisation which has been shared with the CLRN Speciality Group Membership (Local and National) National/Local Speciality Group Speciality Area (if only specific areas within NOT FINISHED) Contact Name Contact Contact Number Research and Innovation Patient and Public Involvement (PPI) Group Patient and public involvement in research All areas of LPFT business as detailed above (R&D areas of interest) Dianne Tetley Organisation R&D Planning Investments Planned Investment Area of investment (e.g. Facilities, Training, Recruitment, Equipment etc) Recruitment Description of Planned Investment 1 Consultant PA to support dementia research and recruitment Value of investment Indicative dates 12, Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details Valid from Valid to Page 9 of 10

10 Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports The Assistant Director of Research, Innovation and Effectiveness also has delegated HR responsibility with regard to managing research. LPFT R&D department act as a one-stop shop in relation to research passports, receiving and processing all requests with regard to Research Passports, Letters of Access, Honorary Contracts and the issue of NHS to NHS pro-formas where appropriate. Assistant Director of Research, Innovation and Effectiveness is the signatory for all verifications of Research Passports; Research Coordinator is deputy signature. Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes Escalation Process All research governance issues should be report to the RM&G Lead/Research Coordinator in the first instance; issues are escalated where appropriate to the Assistant Director of Research, Innovation and Effectiveness who will seek advice from the Medical Director (Corporate Lead responsibility for research) 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 collaborate in Comments LPFT operates ReDA; all research studies, planned or actual (portfolio or non-portfolio) are entered onto ReDA further information from Research Coordinator in the first instance. LPFT actively seeks to host and facilitate NIHR studies and work in collaboration with others to develop research submissions to NIHR funding streams contact Research Coordinator in the first instance. 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) LPFT Research Department offer a one stop shop in that feasibility, permissions, facilitation and close-down are supervised from one small team. We aim to offer a quality service, completing approval and recruitment to NIHR time and target standards. All enquiries via the Research Coordinator in the first instance. Information can be viewed via the LPFT public website; via SHARON (staff intranet). A database of staff publications is available via the R&D Department. LPFT is strong in the development and implementation of innovations contact Assistant Director of Research, Innovation and Effectiveness in the first instance. LPFT has an active and dynamic Research and Innovation Public and Patient Involvement (PPI) Group contact Assistant Director of Research, Innovation and Effectiveness in the first instance. Page 10 of 10