Discussion Assurance Approval Regulatory requirement Mark relevant box with X Prepared by: Carole Paley

Transcription

1 Report to: Board of Directors Date of Meeting: 26 February 2014 Report Title: Research and Development Operational Capability Statement (revision) Status: For information Discussion Assurance Approval Regulatory requirement Mark relevant box X X with X Prepared by: Carole Paley Executive Sponsor Ann Wagner (presenting): Appendices (list if applicable): N/A Purpose of the Report To provide an operational capability statement for research and development which is regularly updated and published externally. Key points for discussion The current RDOCS has recently been reviewed and several changes made as follows: Addition of new SOPs Change of staff contacts Changes to telephone numbers Change of title for Research Manager Change from R&D Committee to Research & Innovation Strategy Group Recommendation Action required by the Board of Directors The Board of Directors is asked to approve the recent revisions to this document, approve it for publication on the Trust external website and the DH website and to delegate authority to Ann Wagner to sign off this version on behalf of the Board.

2 v1c NIHR Guideline B01 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Updated by RDOCS 002 V /02/ /12/2014 Carole Paley 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 Signed on behalf of the Trust Board Signed by The Director of Strategy and Business Development, Ann Wagner 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 Number: Contact Other relevant information: Airedale NHS Foundation Trust Ann Wagner, Director of Strategy and Business Development Dr. Carole Paley, Head of Research & Innovation Airedale NHS Foundation Trust Research Office, Ward 12, Skipton Road, Steeton, Keighley, BD20 6TD (Direct line) carole.paley@anhst.nhs.uk Page 1 of 13

3 Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: Name: Contact Number: Contact Contact 2: Role: Name: Contact Number: Contact Contact 3: Role: Name: Contact Number: Contact Research Governance Manager Mechele Couch-Upite Research Governance Officer Lucy Sootheran Research Admin Assistant Hazel Calcott Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) Head of Research and Innovation 0.82 Research Governance manager 1 Research Governance Officer 0.8 Research Admin Assistant 0.2 Whole Time Equivalent Comments indicate if shared/joint/week days in office etc Working days: Monday, Wednesday, Thursday and Friday Working days: Monday - Thursday Flexible working Mon-Fri Wednesdays only Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.) Reporting Structures Page 2 of 13

4 The Research and Innovation Strategy Group meets quarterly and reports into the Quality and Safety Operational Group (Q-SOG) and Quality and The Executive Assurance Group which have delegated powers from the Foundation Trust Board. An annual report is also submitted to the Trust Board. In addition, quarterly KPIs are reported to the board. Internal assurance and monitoring is through the quarterly Quality and Safety Report. A flowchart showing the reporting structure is included below. Trust Board Executive Assurance Group Quality & Safety Operational Group Research & Innovation Strategy Group Research Team Clinical multidisciplinary Teams Page 3 of 13

5 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 Yorkshire CLRN Yorkshire Cancer Research Network Yorkshire Stroke Research Network Diabetes Research Network Medicines for Chridren Research Network Role/relationship of the Research Network eg host Organisation Member Organisation Member organisation Member Organisation Collaborating site Collaborating site Add lines in the table as required by selecting and then copying a whole Excel row which is a part of the table (note: select and copy the row not cells in the row). Then select a row in the table and 'insert copied cells'. (Please do not select and copy individual cells or groups of cells as this does not preserve formatting.) Information on collaborations and partnerships for research activity (e.g. Biomedical Research Centre/Unit, Other NHS Organisations, Higher Education Institutes, Industry) Current Collaborations / Partnerships Details of Organisation Name Contact Name address Contact Number Collaboration / Bradford Institute for Health Research (BIHR) BIHR are CLRN cluster lead. For West Tracy Watson tracy.watson@bthft.nhs.uk Add lines in the table as required by selecting and then copying a whole Excel row which is a part of the table (note: select and copy the row not cells in the row). Then select a row in the table and 'insert copied cells'. (Please do not select and copy individual cells or groups of cells as this does not preserve formatting.) 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 Study Administering Questionnaires As Sponsoring Organisation N/A N/A As Participating Organisation (phases 2-3) As Participant Identification Centre (phases 2-4) OTHER Add lines in the table as required by selecting and then copying a whole Excel row which is a part of the table (note: select and copy the row not cells in the row). Then select a row in 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 4 of 13

6 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) Administration of Radioactive Substances Advisory Committee (ARSAC) Licenses obtained as required for individual trials in association with the Radiological Protection Adviser. Varies according to individual trial. Varies according to individual trial. 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 Contact Specialist facilities that may be provided (eg Contact Name within Service Department Pathology number/type Clinical Chemistry of Dr Afruj Ruf Haematology/Blood Transfusion Dr Afruj Ruf Histopathology Dr Afruj Ruf Microbiology Dr Afruj Ruf Radiology CT: 2 scanners. 128 slice and 64 slice Martin Cobley martin.cobley@anhst.nhs.uk Details of any internal agreement templates and other comments MRI: 1 scanner.1.5 Tesla Martin Cobley martin.cobley@anhst.nhs.uk Plain film: 3 available units all linked to PACS Ultrasound: 3 available units DEXA: 1 scanner Fluoroscopy: 2 units Martin Cobley Martin Cobley Martin Cobley Martin Cobley martin.cobley@anhst.nhs.uk martin.cobley@anhst.nhs.uk martin.cobley@anhst.nhs.uk martin.cobley@anhst.nhs.uk Nuclear medicine Martin Cobley martin.cobley@anhst.nhs.uk This service is based at Bradford but contact may be made via Martin Cobley. Specialist radiological protection advice (based in Bradford) Sharan Packer Sharan.Packer@bradfordhospitals.nhs.uk A service-level agreement exists between Airedale NHS FT and the RPA advisor at St Lukes, Bradford. Pharmacy Aseptics, microbials Carl Booth carl.booth@anhst.nhs.uk Page 5 of 13

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 Contact Service Department Archiving Storage of archived materials, e.g. patient Carole Paley, Head Contracts notes. Review of clinical trial agreements and of Research & Innovation Carole Paley, Head Data management support main signatory Cancer team data management of Research & Innovation Helen Hothersall Details of any internal agreement templates and other comments Finance Controls R&D finance (income/exp) and Michelle Mansour provides budget and forecast information. Information Technology Advice on implementation of IT systems Tim Rycroft and software to support research and maintenance of current systems, accounts and internal Sharepoint. Legal Advice on contracts, indemnity insurance. HR Statistical support Head of HR. Will provide contact details of correct HR advisor on Hon contracts, research passports, letters of access, staffing. Occasional support/advice on statistics may be arranged. Nick Parker Carole Paley, Head of Research & Innovation Caldicott Guardian Caldicott Guardian Review Dr Justin Tuggey Healthcare Governance Risk Management and integrated Alison Fuller governance Formal organisational commitment to supporting the Research Passport scheme. Researchers are expected to organise their own statistical support. However, occasionally this is not possible and we have SPSS support and advice available for this eventuality. CQC registration Add lines in the table as required by selecting and then copying a whole Excel row which is a part of the table (note: select and copy the row not cells in the row). Then select a row in 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 6 of 13

8 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 Oncology (Medical) Consultant Medical Oncologist Dr Michael Crawford Consultant Medical Oncologist Oncology (Medical) Dr Shazza Rehman Oncology (Medical) Consultant Medical Oncologist Dr Andrew Conn Oncology (Medical) Consultant Medical Oncologist Dr Chris Bradley Consultant Medical Oncologist Oncology (Medical) Dr Sue Cheeseman Oncology (Medical) Consultant Medical Oncologist Dr Simon Brown Haematology Consultant Medical Oncologist Dr Ann Cuthbert Surgery Consultant Surgeon Mr Ian Hutchinson Surgery Consultant Surgeon Mr Ali Nejim Surgery Consultant Surgeon Mr Basit Khan Gastroenterology Consultant Gastroenterologist Dr Chris Healey Gastroenterology Gastroenterology Consultant Gastroenterologist Clinical Specialist IBD Nurse Dr Richard Shenderey Joanna McConnell Diabetes Consultant Diabetologist Dr Andrew Pettit Paediatrics Consultant Paediatrician Dr Pronab Bala Paediatrics Paediatrics Consultant Paediatrician Associate Specialist Paediatrician Dr Matthew Babirecki Dr Amanda Davey Paediatrics Consultant Paediatrician Dr Sarah Hayes Paediatrics Consultant Paediatrician Dr Gary Savill Page 7 of 13

9 Obstetrics and Gynaecology Consultant Obstetrician Dr Kathleen Graham Consultant Obstetrician Obstetrics and Gynaecology Mr Naren Samtaney Microbiology Consultant Microbiologist Dr Paul Godwin Histopathology Consultant Histopathologist Dr John O'Dowd Histopathology Consultant Histopathologist Dr Philip Da Costa Palliative Care Consultant in Palliative Medicine Dr Linda Wilson Consultant in Palliative Medicine Palliative Care Dr Helen Livingstone Stroke Consultant Stroke Physician/Medical Director Dr Andrew Catto Consultant Stroke Physician Stroke Dr Samantha Mawer Cardiology Consultant Cardiologist Dr Basel Hanbali Critical Care/Anaesthetics Consultant Anaesthetist Dr John Scriven Rheumatology Consultant Rheumatologist Dr Shabina Sultan Midwifery Head of Midwifery Claire Mathews Physiotherapy Professional Lead Physiotherapy Kelvin Whiting Elderly Medicine Consultant Elderly Medicine Dr Paul Milnes Occupational Therapy Head Occupational Therapist Ms Sue Siddons Cancer - haematology and oncology Lead research nurse and main contact for Alison Shaw alison.shaw@anhst.nhs.uk clinical trials for this area of interest. Cancer - haematology and oncology Clinical Nurse Specialist Haematology and Pat Dyminski patricia.dyminski@anhst.nhs.uk Oncology. Stroke Lead research nurse and main contact for Brigid Hairsine brigid.hairsine@nhs.net clinical trials for this area of interest. Cardiology Research nurse and main contact for Sally Doherty sally.doherty@anhst.nhs.uk clinical trials for this area of interest. Page 8 of 13

10 Gastroenterology Clinical Trials Coordinator and main Roman Galaska contact for clinical trials for this area of Diabetes interest. Clinical Trials Coordinator and main Roman Galaska contact for clinical trials for this area of Critical Care interest. Nurse consultant Rachel Binks Rheumatology Research nurse and main contact for Mandy Swanepoel clinical trials for this area of interest. Paediatrics/Medicines for children Research nurse and main contact for Mandy Swanepoel clinical trials for this area of interest. 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) Yorkshire Cancer Research Network (Local) Cancer N/A Contact Name Alison Shaw Contact Number Yorkshire Stroke Research Network (Local) Stroke N/A Brigid Hairsine Diabetes Research Network (National) Diabetes N/A Mandy Swanepoel Medicines for Children Research Network (National) N/A N/A Mandy Swanepoel Organisation R&D Planning and Investments Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) No additional investment is planned at present. Description of Planned Investment Value of Investment Indicative dates Page 9 of 13

11 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details Valid to RD/SOP/01 Preparation, Review and Approval of Standard Operating Procedures for Research Describes the procedures used when preparing SOPs. RD/SOP/02 Setup and Control External Agreements Describes the procedures used when setting up research agreements and contracts with external organisations. RD/SOP/03 Setup and Control Internal Agreements Describes the procedures used when setting up research agreements with internal departments within the Trust. RD/SOP/04 Setup and Control Study Processes Describes the checks and processes required in study set-up which enable the Trust to manage risks to itself, its staff and patients, and to the integrity of the Study RD/SOP/05 Granting NHS Permission for Research Projects that are NOT Clinical Trials of Investigational Medicinal Products (CTIMPS) Describes the processes involved when setting up trials which are not trials of investigational medical products. RD/SOP/06 Granting NHS Permission for Clinical Trials of Investigational Medicinal Products (CTIMPs) Describes the processes involved when setting up trials which are trials of investigational medical products (CTIMPS). RD/SOP/07 Study Quality Control and Management Describes the procedures the R&D office uses when providing a proportionate level of oversight of a study on behalf of the Trust. RD/SOP/08 R&D SAE/SUSAR Handling Procedure Describes the processes used when an expected or unexpected serious adverse event occurs. RD/SOP/09 Site Study Closedown Describes the process of closing a study. RD/SOP/10 Setting up and Controlling Finance Describes the financial processes involved prior to the start of a study. RD/SOP/11 Overseeing Organisational Study Finance Describes the overseeing of financial processes during the study and finalising the study finances on closedown Page 10 of 13

12 RD/SOP/12 Processing and managing Amendments Describes the processes involved in checking and agreeing study amendments RD/SOP/13 Archiving of Study Documents Describes the process for archiving all study documents locally RD/SOP/14 Application Process of An Honorary Contract, Research Passport or Letter of Access Describes the processes involved in agreeing access to researchers from outside the trust. Describes how trial site files should be set up, what they RD/SOP/15 Site File Set-Up and Maintenance 29/08/2013 should contain and the procedures for maintaining them. RD/SOP/16 Obtaining Informed Consent in Clinical Trials Describes the process involved in obtaining informed consent for participants taking part in clinical trials Gives a description of how departmental authorisation is Costing and trial authorisation procedure RD/SOP/17 obtained prior to trial set-up and how trials should be 04/09/2013 for Key Service Support Departments costed. Describes how clinical trials are set up and managed Set-up and management of clinical trials RD/SOP/18 (hosted studies) from the receipt of a site specific 04/09/2013 (hosted studies only) information form and throughout the course of the trial. Describes the process of booking out, retrieving and RD/SOP/19 Handling of medical records 04/09/2013 returning medical records. RD/SOP/20 Histopathology Procedures Describes the processes involved when samples such as tumour blocks need to be retrieved from Histopathology. 04/09/2013 Page 11 of 13

13 Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports Research Passports (RPs) are managed by the R&D Office and HR in accordance with the current guidance: HR Good Practice Resource Pack ( The flowchart for processing research passports and letters of access (LOAs) is shown below. Where no RP is in place, request researcher to complete RP form and submit to lead NHS HR Dept together with copies of CV, CRB form, OH clearance and other relevant ID documents. HR completes relevant checks, including issue of HRC if necessary and validates RP. HRC issued where necessary Researcher provides RP along with research documentation to R&D at participating NHS site. NHS is researcher s substantive employer Non-NHS employee (e.g. University student) Researcher liaises with R&D at their employing Trust to request an NHS to NHS proforma confirming pre-engagement checks Researcher provides host trust R&D office with a copy of CV and the signed NHS to NHS proforma for review. Researcher has direct patient contact R&D assesses RP and determines whether researcher will have direct or indirect patient contact Researcher has indirect patient contact (e.g. questionnaires) or will not come on site OH Clearance obtained Letter of permission issued for research sent to PI Is RP/HRC in place? Obtain OH clearance ID badge issued YES Obtain OH Clearance NO HR to do preengagement checks and issue HRC Letter of Access issued. ID badge issued ID Badge issued ID badge issued Note: The boxes highlighted in blue show actions to be done at lead NHS site. HRC will be issued by lead site if researcher is carrying out research on that site; if not, a LOA will be issued. Page 12 of 13

14 Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes Escalation Process The R&D Strategy Group, chaired by the Director of Innovation, Research and Development, will discuss any issues arising which cannot be resolved through day to day governance processes. Depending on the issue, the matter may also be referred to the relevant specialist, e.g. the Trust legal representative, the Caldicott Guardian, Risk Manager, Medical Director or Assistant Director of Healthcare Governance. The matter may also be discussed by the Quality and Safety Advisory Group or the Quality and Safety Operational Group. If the issue is a Suspected Unexpected Serious Adverse Reaction (SUSAR) this will be reported via the Risk Department and escalated through the Serious Untoward Incident procedure within the Trust. All adverse reactions are automatically reported to the trials office for the Trial concerned. 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 The trust holds an internal database and tracker which lists all the current and planned studies. In addition to this all studies undergoing the approval process are tracked at each stage and studies currently running are monitored for level of patient recruitment and performance against target recruitment. All National Portfolio studies currently running are listed on Sharepoint, together with their protocols and other study doumentation. 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) Information regarding publications, conference presentations/posters and the outcomes of research are held in the R&D Office. A register of IP is also held in the R&D office. Page 13 of 13