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 V5 01/04/ /03/2016 Trust Board 31st March 2016 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@thh.nhs.uk Contact 2: Role: Name: Contact Number: Contact Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) R&D Director R&D Manager Research Nurse Cancer and Generic Data Manager / Clinical Trials Coordinator Haematology Research Nurse/Trial Coordinator Cardiology / Diabetes research nurse Research Nurse Stroke Research Midwife Other project specific research staff Whole Time Equivalent 1 PA /per week 0.8WTE 1 WTE 1WTE 1WTE 1 WTE 0.6WTE 0.6 WTE Commments indicate if part time/full time/shared/joint etc R&D Director & he is also a Cardiology Consultant Band 8b 30 hours/ week Band 7 part funded by North West London: Clinical Research Network core funds (CRN) (0.2WTE) Band 5 funded by the CRN Band 6 funded from commercial research income and CRN Band 7 funded from commercial research income and CRN Band 6 funded by the CRN Band 6 funded by CRN 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 > Chief Executive / Medical Director R&D Steering Group is chaired by the R&D Director and feeds into the Trust Board via the Medical Director 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 Details of Collaboration / Partnership (e.g. Organisation Name University/Organisation Joint Office, external provider of pathology services to Organisation, etc, Contact Name effective dates) Informal - Brunel University Head of School for Health and Social Care on R&D Steering Group. Collaborative research undertaken developing research ideas and submitting joint research grants. Lorraine Desouza address lorraine.desouza@brunel.ac.uk Contact Number

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 applicable) PCT 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 Contact Name within Service Department Pathology General Pathology Services Racheal Scofield ext Radiology Specialist facilities that may be provided (e.g. number/type of scanners) General X-ray Services, MR!, CT, Ultrasound Graham Smith Dr Zarni Win Contact Pharmacy General Pharmacy Services Andrew Caunce ext Contact number ext Details of any internal agreement templates There are no internal agreement templates, where pathology support is required for trials, approval by is sought by a member of the R & D Team from Rachel Scofield There are no internal agreement templates, where radiology support is required for trials, approval by is sought by a member of the R & D Team from Graham Smith and Dr Zarni Win Outsourcing of some services to Baxter's Compounding unit at Mount Vernon Hospital Compounding Chemotherapy Drugs for parenteral use for the Haematological patients Cardiology ECG, ECHO 24 hour tapes Alison Rochelle Alison.rochelle@thh.nhs.uk ext PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager geraldine.landers@thh.nhs.uk 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 Archiving External contract for the Archiving of Closed Clinical Trials Files Contact Name within Service Department Susan Shrumpton Humphreys Plus Contact orders@datamanagement.co.uk Contracts Geraldine Landers geraldine.landers@thh.nhs.uk 3021 Data management support Polly Needs Polly.needs@thh.nhs.uk 3021 Finance Suzanne King suzanne.king@thh.nhs.uk 3525 Contact number Information Technology IT Help Desk ithelpdesk@thh.nhs.uk 4400 Legal Geraldine Landers geraldine.landers@thh.nhs.uk 3021 Personnel Jacqui Scarlett jacqui.scarlett@thh.nhs.uk 3418 Statistical support Paul Bassett paul@statsconsultancy.co.uk Details of any internal agreement templates Geraldine Landers R&D Manager identified as the Trust R&D Archivist. See Archiving SOP National templates used Works mainly on Haematology and Cardiology multicentre portfolio adopted studies. Any other support required to be negotiated through R&D Manager Support with Budget management and project costing other than when the national costing template is being used (commercial research ) non commercial and local projects not formally costed if they have Service Manager approval. Also supports the completion of the NIHR Finance Tool None None National Research Passport documentation External statistician paid on a per project basis PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager

6 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 Predominately Multi-centre portfolio adopted studies Dr Richard Kaczmarski undertaken commercial and non commercially funded Other Cancers Predominately Multi-centre portfolio adopted studies Alexandra Diaz undertaken Paediatrics and neonatal research Predominately Multi-centre portfolio adopted studies undertaken Dr Richa Ajitsaria Other non cancer studies Multicentre portfolio adopted studies undertaken Alexandra Diaz Ophthalmology Predominately Multi-centre portfolio adopted studies undertaken commercial and non commercially funded Sheena George and Stroke Predominately Multi-centre portfolio adopted studies undertaken Melinda Holden Reproductive Health and Childbirth Multicentre portfolio adopted studies undertaken Dr Shruti Mohan Ext 2597 Cardiology and diabetes Predominately Multi-centre portfolio adopted studies undertaken commercial and non commercially funded Natahsha Mahabir 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 Contact Number NIHR CRN: North West London Cancer Outer North West London Trusts Dr Richard Kaczmarski Richard.Kaczmarski@thh.nhs.uk NIHR CRN: North West London Ophthalmology Dr Sheena George Sheena.George@thh.nhs.uk and

7 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

8 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details SOPV2 Archiving and Destroying Documents SOPV4 Case Record Form (CRF) Completion Audit for Research Governance Purposes and Study SOPV2 Monitoring SOPV2 Taking Informed Consent Preparation for Inspection by the Regulatory SOPV2 Authority SOPV2 Adverse Event Reporting Audit for Research Governance Purposes and Study SOPV2 Monitoring SOPV3 Definition of Responsibilities SOPV2 Study Files and Filing 24 pharmacy SOP's for use in Pharmacy by pharmacy personnel conducting CT1 - CT24 Pharmacy SOP's and managing clinical trials in pharmacy - Managed and held in Pharmacy and are currently being reviewed and will be updated by the expiry date. Provides a framework for research which complies with good research practice Policy V1 Research Governance Policy as detailed the Research Governance Framework for Health and Social Care (2nd edition) 2005 Valid from Valid to 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 certificate. The 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 letter of access and s them to a named HR Manager (currently Jacqui Scarlett) who signs the letter and sends it to the researcher. The hard copies of the documents sent by the researcher are sent to the HR Manager and kept in the HR Files. A copy of the letter of access or the HRC is sent to the R&D Manager by the HR Manager. The letter and HRC templates are held on the R&D shared drive. 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 the decision a meeting is set up with the R&D Manager, Director and the Researcher to discuss the issue and its resolution. The R&D Director consults the Chief Executive, Medical Director or other expert in the organisation for advice. The decision of the R&D Director is final. If the situation is of a strategic nature or may require a re-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.

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 collaborate in. 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) The R&D Office maintain a register of all research undertaken in the organisation. It has web pages on the Trust intranet and internet sites where much of the information is held regarding policies and procedures, Research SOP's Contact details, Staff publications and R&D Processes