OxB01 v1.00. R&D Operational Capability Statement

Transcription

1 OxB01 v1.00 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by OxB01 v /03/ /03/ /03/2011 Board of Directors 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) Oxleas NHS Foundation Trust Dr Ify Okocha (R&D Chair and Medical Director) Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: Name: Contact Number: Research and Knowledge Manager: research governance lead, research contracts lead, CSP lead, NHS permissions signatory, research passport lead, industry study lead x5032

2 Contact Contact 2: Role: Name: Contact Number: Contact Head of Quality and Audit: to be contacted in the absence of the Research and Knowledge Manager Rhoda Iranloye Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) Research governance lead Whole Time Equivalent Commments indicate if part time/full time/shared/joint etc Contracts lead CSP lead NHS permissions signatory 1.0 WTE (Research and Knowledge Manager) Full time Research passport lead Industry study lead 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 Trust has an R&D Steering Group, the Chair of which is the Medical Director. The Group meets quarterly and is accountable to the Clinical Effectiveness Group (CEG), to which it submits quarterly summary reports of research activities occurring within the Trust, including current levels of local recruitment to NIHR portfolio studies and other NHS Research Ethics Committee-approved research. The CEG in turn reports to the Trust's Executive Board.

3 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) Comprehensive Local Research Network (CLRN) London (South) Mental Health Research Network (MHRN) South London and South East Hub Dementias and Neurodegenerative Diseases Research Network (DeNDRoN) South Coast Hub Role/relationship of the Research Network eg host Organisation Collaborator Collaborator Collaborator 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 Contact Name address Tizard Centre, University of Kent Research for Patient Benefit grant co-applicant Professor Glynis Muprhy g.h.murphy@kent.ac.uk Imperial College, University of London Health Technology Assessment co-applicant Carol Paton c.paton@imperial.ac.uk Salomon's Centre for Applied Social and Psychological Development, University of Canterbury Knowledge Transfer Partnership, Research for Patient Benefit grant co-applicant Dr Douglas MacInnes doug.macinnes@canterbury.ac.uk South London Health Innovation and Education Cluster HIEC membership Dr Adrian Treloar adrian.treloar@oxleas.nhs.uk 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 study Administering Questionnaires Qualitative study As Sponsoring Organisation As Participating Organisation III, IV As Participant Identification Centre III, IV

4 Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Example: Human Tissue Authority Licence None Licence Details N/A Licence Start Date (if applicable) N/A PCT ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices Not applicable Organisation Services Information on key clinical services contacts and facilities/equipment which may be used in studies for suporting R&D governance decisions across the organisation. Clinical Service Departments Service Department Specialist facilities that may be provided (eg number/type of scanners) Contact Name within Service Department Contact Contact number Pharmacy None Carol Paton x5876 Information on key management contacts for suporting 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 Please liaise with contact for further details Terry Folkes Data management support Please liaise with contact for further details Matthew Finch x5054 Finance Please liaise with contact for further details Diane Pincott Information Technology Please liaise with contact for further details Lee Christie x5019

5 Legal Please liaise with contact for further details Caroline Hall Personnel Please liaise with contact for further details Janna Maxfield x5800 Information governance and data protection Please liaise with contact for further details Julie Lucas Organisation R&D Interests Information on the areas of research interest to the Organisation Organisation R&D Areas of Interest Area of Interest Details Contact Name Contact Anxiety Asperger's syndrome Assertive outreach in community mental health Attachment disorders Attention Deficit Hyperactivity Disorder Autism Bipolar disorder Care navigation in acute hospitals Complex needs Delirium Dementia

6 Depression District community nursing Early intervention in psychosis Forensic mental health services Healthcare needs in mental health or learning disabilities Improving access to psychological therapies Intermediate care beds Learning disabilities Obsessive-compulsive disorder Outcomes Panic disorder Patient experience Perinatal psychiatry Personality disorder Phobias Post-traumatic stress disorder Psychiatric intensive care

7 Psychopharmacology Psychosis Recovery Schizophrenia Self-harm Service configuration Sexual disorders Social inclusion Substance misuse Suicide Urgent care centre 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 group) Contact Name Contact Local Local Age and aging Neurosciences Dr Adrian Treloar Dr Adrian Treloar adrian.treloar@oxleas.n hs.uk adrian.treloar@oxleas.n hs.uk Organisation R&D Planning and Investments

8 Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Recruitment Description of Planned Investment Placement of one 1.0 WTE Clinical Studies Officer from the South London MHRN within the Trust to support NIHR portfolio studies Value of Investment TBA Recruitment Placement of one 0.6 WTE Clinical Studies Officer from the South London MHRN within the Trust to su TBA Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details Valid from OxB01 Manage R&D Operational Capability Statement Describes the procedures the Trust's R&D Office uses when managing the content of the R&D Operational Capability Statement OxB01 R&D Operational Capability Statement Provides a Board level operational framework which empowers the Trust's R&D Office to undertake the management of R&D OxP02 Manage study Participating Planning Tool v1 Describes the procedures the Trust's R&D Office uses when completing a quick assessment using the Participating Organisation study Planning Tool OxP02 Planning Toolkit for Participating Organisation v1 Helps the Trust's R&D Office to assess any concerns about a study which may delay NHS Permission or cause issues with study delivery OxP03 Confirm study Approvals v1 Describes the procedures the Trust's R&D Office uses when confirming that study approvals have been completed OxP04 Setup and Control External Agreements v1 Describes the procedures which the Trust's R&D Office uses when setting up and controlling External Agreements prior to study start Describes the procedures the R&D Office uses when setting up and OxP05 Setup and Control Internal Agreements v1 controlling Internal Agreements with services and staff within the Trust prior to study start OxP06 Setup and Control study Processes v1 Describes the procedures which the R&D Office uses when setting up and controlling study processes OxP07 Give NHS Permission v1 Describes the procedures the Trust's R&D Office uses in order to issue NHS Permission OxP08 Oversee study v1 Describes the procedures the Trust's R&D Office uses when providing a proportionate level of oversight of a study

9 Describes the procedures the Trust's R&D Office uses when managing the OxP09 Site study Closedown v1 conclusion of a study Describes the procedures which the Trust's R&D Office uses when OxS02 Confirm study Definition v1 confirming the categorisation of a study Describes the procedures which the Trust's R&D Office uses to ensure the OxS03 Ensure study Protocol is Managed v1 study protocol is managed by the Senior Investigator Ensure study Funding and Approvals are Managed Describes the procedures which the Trust's R&D Office uses when ensuring OxS04 v1 study funding and approvals are confirmed Describes the procedures which the Trusts's R&D Office uses as a OxS05 Manage study Sponsor Planning Tool v1 Sponsoring Organisation when completing a quick assessment using the study Sponsor Planning Tool ( Planning Tool ) OxS05 Describes the procedures the Trust's R&D Office uses as a Sponsoring Planning Toolkit for SPONSORING Organisation Organisation when completing a quick assessment using the Sponsoring v1 Organisation study Planning Tool Describes the procedures which the Trust's R&D Office uses as a OxS06 Give Decision on Sponsoring v1 Sponsoring Organisation in order to give a sponsoring decision to the Investigator Describes the procedures which the R&D Office uses as a Sponsoring OxS07 Provide and Manage External Agreements v1 Organisation when providing and managing agreements with external parties such as Study Participating Organisations Describes the procedures which the Trust's R&D Office uses as a OxS08 Ensure NHS Permission is Received by the CI v1 Sponsoring Organisation to ensure that copies of the NHS Permission Letter for each Participating Organisation are received by the Chief Investigator Describes the procedures which the Trust's R&D Office uses as a OxS09 Ensure study Oversight v1 Sponsoring Organisation when overseeing a study throughout the study period OxS10 Ensure study Closedown is Managed v1 Describes the procedures the Trust's R&D Office uses as a Sponsoring Organisation to confirm that a study has been closed appropriately Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports The Trust follows, and is fully compliant with, the processes for managing Research Passports as outlined within the National Institute for Health Research (NIHR) document "Research in the NHS - Human Resources (HR) Good Practice Resource Pack". A dedicated spreadsheet records details of all issued access documents. Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes

10 Escalation Process When R&D governance issues cannot be resolved through normal processes they will be referred to the Medical Director (R&D Chair) who will raise such at the Clinical Effectiveness Group for resolution. Planned and Actual Studies Register The Trust uses the CSP RedA and ReDA databases to manage its planned and active research. Other Information For example, where can information be found about the publications and other outcomes of research which key staff led or callaborated in? Other Information (relevant to the capability of the Organisation) All publications authored or co-authored by Trust practitioners are listed yearly by the Knowledge Services department, irrespective of whether these publications are directly related to hosted NIHR portfolio studies.