NIHR Guideline B01 Research & Development Operational Capability Statement V Updated March 20145

Transcription

1 NIHR Guideline B01 Research & Development Operational Capability Statement V Updated March Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCS 001 V6 01/05/ /03/2018 Trust Board 31st March 2018 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 The Hillingdon Hospital R&D Lead / Director (with responsibility for reporting on R&D to the Dr Simon Dubrey Organisation Board) Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: R&D Manager Name: Geraldine Landers Contact Number: Contact geraldine.landers@nhs.net Contact 2: Role: Name: Contact Number: Contact Information on staffing of the R&D Office R&D Team R&D Office Roles Comments Whole Time Equivalent (e.g. Governance, Contracts, etc) indicate if part time/full time/shared/joint etc R&D Director 1 PA /per week R&D Director & he is also a Cardiology Consultant R&D Manager 0.8WTE Band 8b 30 hours/week funded by the North West London (NWL) Clinical Research Network (CRN) Research Nurse Cancer and Generic 1 WTE Band 7 funded by NWL CRN Activity Based Funding (ABF) and by NWL CRN core funds (0.2WTE) Data Manager / Clinical Trials Coordinator 1WTE Band 5 funded by NWL CRN ABF Haematology Research Nurse/Trial Coordinator 1WTE Band 6 funded by NWL CRN ABF, commercial research income and CRN core funds (0.4WTE) Cardiology / Diabetes Research Nurse 1 WTE Band 7 funded by NWL CRN ABF and commercial research income Research Nurse Stroke 0.6WTE Band 6 funded by NWL CRN ABF and CRN core funds (0.3WTE) Research Midwife 0.6 WTE Band 6 funded by CRN core funds (0.6WTE) Ophthalmology Clinical Trials Coordinator 1 WTE Band 5 funded by NWL CRN ABF and surgery division Clinical Trials Pharmacists 1.5 WTE Band 7 funded by NWL CRN ABF, commercial research income and CRN pump prime of 25,530 in 17/18 Other project specific research staff Funded by the individual study centre

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3 Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.) Reporting Structures R&D Manager > R&D Director > Medical Director /Chief Executive R&D Steering Group is chaired by the R&D Director and feeds into the Trust Board via the Medical Director and the Regulation and Compliance Committee Chief Executive formally delegated project approval to the R&D Director The R&D Steering Group meet quarterly and take a strategic lead for Research and Development in the Trust. It is made up from senior managers in the Trust and our academic partners. Information on Research Networks supporting/working with the Organisation. Information on how the Organisation works with the National Institute of Health Research Clinical Research Network (NIHR CRN) Research Networks Research Network (name/location) NIHR CRN: North West London Role/relationship of the Research Network e.g. host Organisation This network encompasses all clinical specialities and provides funding to support the infrastructure and management of NIHR adopted clinical trials. 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 (e.g. University/Organisation Joint Office, external provider of pathology services to Organisation, etc, effective dates) Contact Name address Contact Number Informal - Brunel University Pro-Vice Chancellor, Equality, Diversity and Staff Development Professor of Rehabilitation. Member of Trust R&D Steering Group. Lorraine Desouza lorraine.desouza@brunel.ac.uk Brunel University The proposed collaboration between Hillingdon Hospital, Central and North West London Mental Health Trust (CNWL) and Brunel University offers an exciting opportunity to significantly drive forward the R&D ambition of the Trust. Some of the priorities are: Deliver a sustainable Academic Centre for Health Sciences (ACHS) Increase research and education interactions (Joint conferences, research grants, sessional lecturing or participation, pump priming research, collaborative research) Create an environment of innovation

4 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 (Phases 2, 3, 4) Device Samples Studies Questionnaires As Sponsoring Organisation No No Yes No Yes Yes As Participating Organisation Yes Yes Yes Yes yes yes As Participant Identification Centre Yes Yes Yes Yes yes yes OTHER Yes yes yes Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Licence Details Example: Human Tissue Authority Licence None Licence Start Date (if applicable) Licence End Date (if applic CCG ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices NA

5 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 North West London Pathology Specialist facilities that may be provided (e.g. number/type of scanners) General Pathology Services Contact Name within Service Department Mark Busby Sonia DeCastro Contact Contact number Details of any internal agre There are no internal agree pathology support is requir is sought by a memb and discussed at the R&D Radiology General X-ray Services, MRI, CT, Ultrasound Dr Ziad Meer Dr Zarni Win Zmeer@nhs.net Zarni.Win@imperial.nhs.uk Pharmacy General Pharmacy Services Andrew Caunce Andrew.caunce@nhs.net ext Cardiology ECG, ECHO 24 hour tapes Alison Rochelle a.rochelle@nhs.net ext via ext There are no internal agree radiology support is require is sought by a memb from De Zaid Meer or his d discussed at the R&D Fea There are no internal agree clinical trails pharmacy su by is sought by a me and discussed at the R&D Outsourcing of some servi Compounding unit at Moun Compounding Chemothera use for the Haematologica There are no internal agree cardiology support is requi is sought by a memb and discussed at the R&D PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager geraldine.landers@nhs.net 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 External contract for the Archiving of Closed Clinical Trials Files Humphreys Plus orders@datamanagement.co.uk Contracts Geraldine Landers geraldine.landers@nhs.net 3021 Data management support Geraldine Landers geraldine.landers@nhs.net 3021 Finance Suzanne King suzanne.king1@nhs.net 3963 Information Technology IT Help Desk thh.itservicedesk@nhs.net 4400 Legal Geraldine Landers geraldine.landers@nhs.net 3021 Personnel Binu Arora binu.arora@nhs.net 3418 Statistical support Paul Bassett paul@statsconsultancy.co.uk Details of any internal agre Geraldine Landers R&D M Trust R&D Archivist. See National templates used We employ 1 WTE Data M cross-divisional multi-centr studies. Please contact R& Support with Budget mana costing other than when th template is being used (co commercial and local proje they have Service Manage the completion of the NIHR None None National Research Passpo External statistician paid o PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager

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7 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 Recruitment into multi-centre portfolio adopted research in Haematology Cancer Multi-centre portfolio adopted studies undertaken commercial and non Dr Richard Kaczmarski commercially funded Other Cancers Multi-centre portfolio adopted studies undertaken Mariam Nasseri Melinda Holden or Ext 2826 Paediatrics and neonatal research Multi-centre portfolio adopted studies undertaken Dr Richa Ajitsaria Other non cancer studies eg surgery Multicentre portfolio adopted studies undertaken Mariam Nasseri Critical Care Multi-centre portfolio adopted studies undertaken Elisa Kam Anaesthesia Multi-centre Observational portfolio adopted studies undertaken Ophthalmology Multi-centre portfolio adopted studies undertaken commercial and non commercially funded Sheena George and Stroke Multi-centre portfolio adopted studies undertaken Melinda Holden Ext 2826 Reproductive Health and Childbirth Multicentre portfolio adopted studies undertaken Dr Shruti Mohan Ext 2597 Cardiology, diabetes, Venous Thrombosis Embolism (VTE) Multi-centre portfolio adopted studies undertaken commercial and non commercially funded Natasha Mahabir or Ext 2342 Neurology Multi-centre Observational portfolio adopted studies undertaken in Parkinson's, MS and neuro rehab contact via Geraldine Landers Donated Paed equipm Musculoskeletal, Rheumatology Multi-centre Observational portfolio adopted studies undertaken Dr Michelle Fernando Information on Local / National Specialty group membership within the Organisation which has been shared with the NIHR CRN. Specialty Group Membership (Local and National) National / Local Specialty Group Specialty Area (if only specific areas within group) Contact Name Contact NIHR CRN: North West London Cancer Outer North West London Trusts Dr Richard Kaczmarski r.kaczmarski@nhs.net NIHR CRN: North West London Ophthalmology North West London Trusts Dr Sheena George sheena.george@nhs.net

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9 Organisation R&D Planning and Investments Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Training Description of Planned Investment In-house ICH GCP Training electronic, and face to face in groups and one to one for both CTIMPS and non CTIMPS/informed consent Value of Investment Compliance with ICH GCP guidelines Indicative dates Contact R&D Manager

10 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number R&D001 V1 R&D002 V1 SOP Title Generation Issue and Control of SOPs Template SOP SOP Details Valid from R&D003 V1 Sponsorship Review of new studies R&D004 V1 Host Site Feasibility Review of new studies R&D005 V1 R&D File Set up and Maintenance R&D006 V1 Study review of NHS ability to deliver R&D007 V1 Study Monitoring and oversight R&D008 V1 Pharmacovigilance reporting R&D009 V1 Serious Breach Reporting R&D010 V1 Processing of Amendments R&D011 V1 Closure of a study R&D012 V1 Study Archiving R&D013 V1 Non-compliance Escalation Process R&D014 V 5 Case Record Form(CRF) Completion Trust Research SOP for Researchers R&D015 V 5 Definition of Responsibilities Trust Research SOP for Researchers R&D016 V 3 Honorary contracts and Letters of Access Trust Research SOP for Researchers R&D017 V 4 Preparation for Inspection by the Regulatory Bodies Trust Research SOP for Researchers R&D018 V 5 Study Files and Filing Trust Research SOP for Researchers R&D019 V 4 Taking Informed Consent Trust Research SOP for Researchers R&D020 V 4 CT1 - CT24 Policy V1 Training Pharmacy SOP's Research Governance Policy Trust Research SOP for Researchers 24 pharmacy SOP's for use in Pharmacy by pharmacy personnel conducting and managing clinical trials in pharmacy - Managed and held in Pharmacy and currently being reviewed Provides a framework for research which complies with good research practice as detailed the Research Governance Framework for Health and Social Care (2nd edition) 2005 Currently being redrafted Currently redrafted and for review at the R&D Steering Group and ratification by the Patient Safety Committee Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports The R&D Manager receives information from the researchers in the form of Research Passport document (HE employees) with appropriate attachments. NHS employees provide a signed NHS to NHS proforma (from their Trust HR) confirming employment status with CV and GCP documents are checked for completeness and appropriateness of CRB level against the protocol requirements and study methodology by the R&D Manager. If satisfactory the R&D Manager completes the Honorary Research Contract document using the national templates or the let of access or the HRC is then ed to a named HR Manager (currently Binu Arora)and a hard copy is kept in the HR files. A copy of the letter of access or the HRC is sent by the R&D Manager to the researcher and their employer. The letter and HRC templates are held on the R

11 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 Manager assesses all projects and advises the R&D Director of any issues. These issues are then discussed fully between the R&D Manager and the R&D Director. This decision is then discussed with the Researcher by the R&D Manager. If the researcher is unhappy with set up with the R&D Manager, R&D Director and the Researcher to discuss the issue and its resolution. The R&D Director consults the Medical Director or other expert in the organisation for advice and a joint decision will be made which will be final. If the situation is of a strategic natu evaluation in the future (e.g. whether the organisation should be sponsor of CTIMP Studies) it would be reviewed at the next R&D Steering Group meeting and if appropriate recommendations will be made to the Trust Board.

12 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. 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) The R&D Office uses the Local Portfolio Management System (LPMS) EDGE database to maintain a register of all research undertaken in the organisation. In addition the Trust has web pages on the intranet and internet sites where much of the information is held regarding policies Research SOP's Contact details, Staff publications and R&D Processes

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