NIHR Guideline B01 R&D Operational Capability Statement - Colchester Hospital University NHS Foundation Trust

Transcription

1 NIHR Guideline B01 R&D Operational Capability Statement - Colchester Hospital University NHS Foundation Trust 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 RDOCS /01/ /12/ /06/2012 Trust Board A Caldeira RDOCS /01/ /03/ /11/2013 Trust Board A Caldeira RDOCS /04/ /03/ /11/2014 Trust Board A Caldeira 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 Colchester Hospital University NHS Foundation Trust R&D lead / Director (with responsibility for reporting on Dr Sean MacDonnell, Medical Director R&D to the organisation Board) R&D office details: Research & Development Address: Colchester Hospital University NHS Foundation Trust, Colchester General Hospital, Villa 3, Turner Road, Colchester CO4 5JL Other relevant information: The R&D office provides support in all aspects of the research process and peforms the research management and governance of NIHR portfolio and non-portfolio studies to gain NHS permission within national timelines and to permit research activity to be conducted within the trust. All research projects (including student research) involving hospital staff, patients and/or facilities at the trust must have gained both ethics and R&D management approval before the study can start at the trust. If you do not have this letter of approval you may not begin a research project and doing so constitutes research misconduct. The trust is a member CRN: Eastern, hosted by Norfolk & Norwich Foundation Trust. The R&D office is also responsible for the research governance on behalf of North Essex Partnership Foundation Trust. The trust has an established research team who are responsible for the set-up and delivery of all clinical trials. The trust has a proven track record with industry studies, developing patient iniatatives and works towards NIHR high level objectives including NHS permission within 30 days, first patient recruit within 70 days and recruitment to time and target for the duration of the study. Key contact details e.g. Research governance lead, NHS Permissions signatory contact details Contact 1: Role: Medical Director Dr Sean Macdonnell Sean.Macdonnell@colchesterhospital.nhs.uk Contact 2: Role: Director of R&D - NHS Permission Signatory & Chairman of R&D Committee Dr Tony Elston Tony.Elston@colchesterhospital.nhs.uk Contact 3: Role: R&D Manager Ayres Caldeira Contact 4: Page 1 of 9

2 Role: Research Trials Nurse Manager Page 2 of 9

3 Contact 5: Role: Oncology Clinical Trials Manager 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.) Information on staffing of the R&D office. R&D team R&D office roles Whole time (e.g. Governance, contracts, etc) equivalent Director 1 PA Session R&D Manager 1 Research Managers 2 Comments indicate if shared/joint/week days in office etc Signatory for NHS Permissions & Chairman of R&D Committee Research advice, costings, contracts, signatory for amendments approvals, study performance, Feasibility, study set-up, delivery and performance 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 R&D Steering Group manages research activity on behalf of the Trust and is accountable to the People, Organisational & Development Committee. The steering group is chaired by the Director of R&D and its membership includes representatives from active clinical / non-clinical areas and external stakeholders. The steering group committee members meets quarterly to review research activity and to agree research strategy. All decisions on sponsorship of research and NHS permissions are delegated to the Director of R&D on behalf of the R&D Steering Group. Page 3 of 9

4 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) CRN: Eastern Role/relationship of the research network e.g. host organisation Host network to include funding and overall reponsibility for the delivery and performance of research activity Information on collaborations and partnerships for research activity (e.g. Biomedical Research Centre/Unit, other NHS organisations, higher education institutes, industry). Page 4 of 9

5 Current collaborations / partnerships Organisation name Anglia Ruskin University University of Essex Essex Biomedical Sciences Institute (EBSI) Details of collaboration / partnership (e.g. Research Collobarations Research Collobarations Research Collobarations Contact name address Prof. James Hampton-Till James.Hampton-Till@anglia.ac.uk Prof.Elena Klenova klenovae@essex.ac.uk Dr Beverley Wilkinson bwilk@essex.ac.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 x x x x As participating organisation Phase II - IV As participant identification centre Phase II - IV OTHER Academic Student Research Non-portfolio commercial research Information on any licences held by the organisation which may be relevant to research. Organisation licences Licence name Licence details Example: Human Tissue Authority licence Licensable Activity: Making of a post mortem examination, removal of relevant material, Human Tissue Authority Post Mortem Licenses storage of a body or relevant material. Licensing number: 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. Page 5 of 9

6 Number/notes on General Practitioner (GP) practices Under the E&H CLRN members trusts, the following Practices are research active NHS NEE:Bluebell, Creffield Medical Centre, Mill Road, Mersea Road, Parsons Heath NHS MEE: Elizbath Courtauld, Freshwells, Great Notley, Little Waltham 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 John Livermore Radiology Paul Hudson Pharmacy Richard Needle Cardio-Respiratory Sharon Archer Chemotherapy Vanessa Bradbury Radiation Protection Adrian Porter & Mandy Moreton & & Radiology - Breast Unit Monica Dale Monica.Dale@colchesterhospital.nhs.uk Radiotherapy Physics Mark Porter mark.porter@colchesterhospital.nhs.uk Nuclear Medicine Chris Nottage chris.nottage@colchesterhospital.nhs.uk Radiotherapy Sonia Tankard sonia.tankard@colchesterhospital.nhs.uk Details of any internal agreement templates and other comments 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 Outsourced (OASIS UK) Ayres Caldeira Lorna.Dewar@colchesterhospital.nhs.uk Contracts & costings (NIHR Model Agreements) Ayres Caldeira Study Delivery Recruitment, Performance Metrics Ayres Caldeira Lorna.Dewar@colchesterhospital.nhs.uk Debbie.Campbell@colchesterhospital.nhs.uk Finance CRN Budget Simon Oliver Simon.Oliver@colchesterhospital.nhs.uk Finance R&D commercial income, CRN Budget Ayres Caldeira Information Technology LPMS, ReDA, CSP, ODP Ayres Caldeira Legal Contracts, CDA, Ayres Caldeira Details of any internal agreement templates and other comments Page 6 of 9

7 HR Staff contracts Joanne Dickman Statistical support and advice SPSS, Literature reviews, Publications Andy Richardson Training and Development ICH-GCP, Informed Consent, RM&G Ayres Caldeira 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 The Trust has network funded clinical research team who support NIHR studies within the following interest areas. Area of interest Cancer (incl Haematology) Stroke Details Dedicated research team Dedicated research team Contact name Contact Surgery Paediatrics Dedicated research team Dedicated research team Other (Renal, Gastronterology, Opthalmology) Dedicated research team Information on local / national specialty group membership within the organisation which has been shared with the network Specialty group membership (local and national) National / local Specialty group Specialty area (if only specific areas within Contact name group) Contact Ayres Caldeira Lorna CRN Eastern Topuc Specific Dewar Debbie Lorna.Dewar@colchesterhospital.nhs.uk Campbell Debbie.Campbell@colchesterhospital.nhs.uk Organisation R&D planning and investments Planned investment Area of investment (e.g. Facilities, training, recruitment, equipment etc.) Training of researchers R&D research database (ReDA) PPI Description of planned investment GCP Training facilitated through network Annual licence fee payable by R&D Materials, Marketing, Events Value of investment Mandatory Training Indicative dates Refresher, Introductory and on-line Page 7 of 9

8 Research Centre Unit for research services (3-5 year plan) Organisation R&D standard operating procedures register Standard operating procedures SOP ref number SOP title SOP details Valid from Valid to 160 R&D procedure for Reporting Adverse Events and Reactions during a Research Study Approved by PDAC (version 4) 01/08/ /07/ Research & Development Procedures Approved by PDAC (version 5) 01/09/ /08/ Intellectual Property Procedure Approved by PDAC (version 3) 01/04/ /03/2015 Information on the processes used for managing research passports. Indicate what processes are used for managing research passports All application and approvals are facilitated via the R&D office and follows national guidance on the Research passports process. Information on the agreed escalation process to be used when R&D governance issues cannot be resolved through normal processes. Escalation process Issues on research governance that cannot be resolved by the R&D manager are escalated to the Director of R&D and/or to members of the R&D steering group as required. Page 8 of 9

9 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 The R&D department maintains details of all research activity recorded onto the ReDA database and conducts monitoiring of all active and in-follow-up projects. 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) The R&D intranet page records details of publications recied form research or via library services. Outcomes are recorded and reported to the Quarterly R&D Committee. Page 9 of 9