NIHR Guideline B01 R&D Operational Capability Statement

Transcription

1 NIHR Guideline B01 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCS /04/ /03/2014 xx/yy/zzzz xxx vhughes RDOCS /09/ /09/2011 xx/yy/zzzz xxx vhughes 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) Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Contact 2: Contact 3: Contact 4: Contact 5: Hinchingbrooke Healthcare NHS Trust Dr Ingo Hille R&D Manager Dr Goher Ayman goher.ayman@nhs.net R&D Co-ordinator Maxine Glover-Bennett maxine.gloverbennett@nhs.net Lead Clinician R&D - NHS permissions signatory, contract signatory Dr Ingo Hille ingo.hille@nhs.net Deputy Chair R&D Committee - NHS permissions signatory, contract signatory Stephen Cook stephen.cook@nhs.net Medical Director - NHS signatory, contract signatory Dr catherine Hubbard and Mr Hisham Abdel-Rahman catherine.hubbard@nhs.net hisham.abdel-rahman@nhs.net Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) R&D Manager - contracts, finance, staffing R&D Co-ordinator - governance Lead Clinician, R&D Whole Time Equivalent 0.2 wte 0.8 wte 0.05 wte Commments indicate if part time/full time/shared/joint etc part-time part-time part-time

2 Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.) Reporting Structures Please see flow diagram attached for the reporting structure of the R&D Steering Committee within the Trust structure.. The R&D Steering Committee consists of a Lead Clinician (Chair), a deputy chair, R&D Manager, Research Governance Co-ordinator, CLRN representatives and representatives from the research active areas within the Trust. 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) West Anglia CLRN West Anglia Cancer Research Network Thames Stroke Research Network Dendron Research Network Diabetes Research Network Role/relationship of the Research Network eg host Organisation The Lead Clinician for R&D sits on the West Anglia CLRN board. Funding is provided via West Anglia CLRN for Research Governance of portfolio studies. This supports the Research Governance Co-ordinator post at Hinchingbrooke. West Anglia CLRN provide a part-time Research Facilitator to assist in the setting up of studies. Hinchingbrooke hosts a number of West Anglia CLRN Research Nurses who run portfolio studies within the Trust. RM&G support is provided via a RM&G Manager who attends the Steering Group meetings and provides support, in particular, for implementation of new policies. Provide funding for 1 full time research nurse + 1 part time Administrator Ongoing discussion s are being held to set-up up additional stroke studies within the Trust (with Christopher Hille) The trust participates in research within this networks portfolio The trust participates in research within this networks portfolio Information on collaborations and partnerships for research activity (e.g. BRC, BRU, Other NHS Organisations, Higher Education Institutes, Industry) Current Collaborations / Partnerships Details of Collaboration / Partnership (eg Organisation Name University/Organisation Joint Office, external provider of pathology services to Organisation, etc, Contact Name effective dates) Anglia Ruskin University Collaboration with the Vision & Eye Research Unit, Anglia Ruskin Univerisity, Cambridge Prof Shahina Pardhan address shahina.pardhan@anglia.ac.uk Contact Number Papworth Hospital Have a service level agreement with Papworth Hospital to provide R&D Management & Support Dr Ian Smith ian.smith@papworth.nhs.uk Peterborough Hospital Service Level Agreement in place to provide Haematology Research Nurse cover 1.5 days per week Lyndsay Carter Lyndsay.Carter@pbh-tr.nhs.uk ext Peterborough Hospital Pathology at Peterborough Hospital provides histopathology services to the Trust Jo Horsley jo.horsley@pbhtr.nhs.uk

3 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 Clinical Trial of a Medical Other Clinical Studies Human Tissue: Tissue Study Administering Qualitative Study (indicate Phases) Device Samples Studies Questionnaires As Sponsoring Organisation to be agreed on an no individual basis yes yes yes yes As Participating Organisation phases 2-4 yes yes yes yes yes As Participant Identification Centre yes yes yes yes yes yes OTHER Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Example: Human Tissue Authority Licence Licence Details Licence Start Date (if applicable) Licence End Date (if applicable) PCT ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices

4 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 Pathology Radiology Pharmacy Ophthalmology / studies involving use of rooms within the Treatment Centre Oncology Specialist facilities that may be provided (eg number/type of scanners) Contact Name within Service Department David Marshall Dr Tony Booth Stephen Cook Jill Southerden Lynda Hall Contact david.marshall@nhs.net tony.booth@nhs.net stephen.cook@nhs.net jill.southerden@nhs.net lynda.hall@nhs.net Contact number Details of any internal agreement templates 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 No facilities at Hinchingbrooke - all non- Maxine Glover-Bennett maxine.gloverbennett@nhs.net Hinchingbrooke studies must arrange their own archiving off-site Contracts For studies using the model agreements with no Sophie Jackson sophie.jackson@papworth.nhs.uk changes contracts are agreed at Hinchingbrooke. More complex contracts or costings are reviewed bu the R&D Finance Manager at Papworth via a service level agreement. Details of any internal agreement templates Service Level Agreement in place Finance Information Technology Legal Personnel Statistical support Finance Department at Hinchingbrooke involved in budget setting, some invoicing, and advice on finance issues R&D Finance Manager at Papworth available for more complex study related issues. Papworth Hospital holds research accounts for 1 Hinchingbrooke member of staff Specialist services not available. For general IT issues contact the IT Helpdesk Hinchingbrooke does not have specialist legal services. If these were required they would need to be outsourced Support with HR and Research Passport issues Statistical help with writing a grant is available from Papworth Hospital - Linda Sharples or via the Research Design Service Umar Molvi Sophie Jackson IT Helpdesk Jo Patrickson owen.dunn@nhs.uk sophie.jackson@papworth.nhs.uk IT.HD@nhs.net jo.patrickson@nhs.net

5 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 Contact Number Ophthalmology Glaucoma Prof R Bourne rb@rupertbourne.co.uk Oncology Colorectal; Breast; Pancreatic; Haematological Sue Donnelly susan.donnelly@nhs.net Malignancies Respiratory COPD Dr N Simler nicky.simler@nhs.net Obstetrics & Gynacology Janet Driver janet.driver@nhs.uk Gastroenterology Dr Catherine Hubbard Mr Hisham Abdel-Rahman catherine.hubbard@nhs.net hisham.abdelrahman@nhs.net 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 Contact Number Mr Rupert Bourne Ophthalmology Glaucoma Rupert Bourne rb@rupertbourne.co.uk

6 Organisation R&D Planning and Investments Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Training of R&D Team Description of Planned Investment The Trust will provide investment in the R&D team by providing resources for staff to attend regional and national meetings. This will enable staff to keep up-to-date with changing policies within research management and governance. Investment will be provided through study leave and funding of meetings. Value of Investment Indicative dates 1 / 2 times per year per member of staff

7 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOPs currently all under review SOP Title SOP Details Valid from Valid to Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports The Trust complies with the Research Passport scheme Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes Escalation Process Escalation process is as follows: 1. Detailed discussion with investigator to ensure there is no misunderstanding 2. Discussion with CLRN RM&G Manager to see if similar issues have been raised elsewhere and if siimilar support mechanisms can be put into place 3. R&D Manager and Lead Clinician for R&D meet with the Manager and Clinical Director of the service/ area in which the problem has been identified 4. If an agreement cannot be reached the Medical Director / Finance Director will be involved depending if the issue is clinical or financial 5. If agreement cannot be reached the Chief Executive will be involved

8 Planned and Actual Studies Register An up-to-date list of planned and actual studies which have been approved by Hinchingbrooke Hospital is kept on the R&D web-based database (ReDA). A copy is on the Research & Development noticeboard in the library and following the finalisation of the new R&D Intranet pages a copy will be available on the hospital Intranet. 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) Hinchingbrooke Hospital hosts a team of West Anglia CLRN nurses who are active in setting-up and running studies within the Trust. The Trust has an active Ophthalmology Research Team who successfully lead and participate in a number of single and multi-centre glaucoma studies. A number of the services within the Trust are run by Cambridgeshire Community Services and there is a close working relationship between the Trust and CCS R&D departments ensuring smooth R&D Approval for studies which overlap both areas.