NIHR Guideline B01
Research & Development Operational Capability Statement V 5 2015 - 16
Updated March 20145Version History
Version number Valid from Valid to Date approved Approved by Updated by
RDOCS 001 V5 01/04/2015 31/03/2016 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 contactsName of Organisation
R&D Lead / Director (with responsibility for reporting on R&D to the Organisation Board)
Role: R&D Manager
Name: Geraldine Landers
Contact Number: Contact Email: Role: Name: Contact Number: Contact Email:
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Information on staffing of the R&D Office
R&D Office Roles
(e.g. Governance, Contracts, etc) Whole Time Equivalent
R&D Director 1 PA /per week
R&D Manager 0.8WTE
Research Nurse Cancer and Generic 1 WTE
Data Manager / Clinical Trials Coordinator 1WTE Haematology Research Nurse/Trial Coordinator 1WTE
Cardiology / Diabetes research nurse 1 WTE
Research Nurse Stroke 0.6WTE
Research Midwife 0.6 WTE
Other project specific research staff
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Band 6 funded by the CRN
R&D Director & he is also a Cardiology Consultant
Band 6 funded from commercial research income and CRN
Funded by the individual study centre Band 6 funded by CRN
R&D Team
Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details
Band 5 funded by the CRN Organisation Details
Commments
indicate if part time/full time/shared/joint etc
Band 8b 30 hours/ week Contact 1:
Band 7 part funded by North West London: Clinical Research Network core funds (CRN) (0.2WTE) [email protected]
Dr Simon Dubrey
Band 7 funded from commercial research income and CRN The Hillingdon Hospital
01895 279021
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Research Networks
Research Network (name/location) NIHR CRN: North West London
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Current Collaborations / Partnerships
Organisation Name
Informal - Brunel University
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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)
This network encompasses all clinical specialities and provides funding to support the infrastructure and management of NIHR adopted clinical trials.
Lorraine Desouza [email protected]
Reporting Structures
Information on collaborations and partnerships for research activity (e.g. BRC, BRU, Other NHS Organisations, Higher Education Institutes, Industry) Role/relationship of the Research Network e.g. host Organisation
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.
Head of School for Health and Social Care on R&D Steering Group. Collaborative research undertaken developing research ideas and submitting joint
research grants.
Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.)
Details of Collaboration / Partnership (e.g. University/Organisation Joint Office, external provider of pathology services to Organisation, etc, effective dates)
Email address
Organisation Study Capabilities
Information on the types of studies that can be supported by the Organisation to the relevant regulatory standards
CTIMPs (Phases 2, 3, 4)
Clinical Trial of a Medical Device
Other Clinical Studies Human Tissue: Tissue Samples Studies
Study Administering Questionnaires
Qualitative Study
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
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Which licences does the organisation hold which may be relevant to research?
Licence Name
Example: Human Tissue Authority Licence
None
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PCT ONLY: Information on the practices which are able to conduct research
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Yes
Number/notes on General Practitioner (GP) Practices
Types of Studies Organisation has capabilities in (please tick applicable)
NA
OTHER
Organisation Licences
yes
Licence Start Date (if applicable)
yes
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.
Service Department Contact Name within
Service Department
Contact number
Pathology Racheal Scofield ext. 3599
Radiology Graham Smith
Dr Zarni Win
ext. 3329
Pharmacy Andrew Caunce ext. 3722
Cardiology Alison Rochelle ext. 2601
01895 279021
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Information on key management contacts for supporting R&D governance decisions across the organisation.
Department Specialist services that
may be provided
Contact Name within Service Department
Contact number
Archiving Susan Shrumpton
Humphreys Plus
01923 252447
Contracts Geraldine Landers 3021
Data management support Polly Needs 3021
Finance Suzanne King 3525
Information Technology IT Help Desk 4400
Legal Geraldine Landers 3021
Personnel Jacqui Scarlett 3418
Statistical support Paul Bassett 07905 530446
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Specialist facilities that may be provided (e.g. number/type of scanners)
[email protected] [email protected] Clinical Service Departments
None General Pathology Services
General X-ray Services , MR! , CT, Ultrasound
General Pharmacy Services
PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager ECG, ECHO 24 hour tapes
There are no internal agreement templates, where pathology support is required for trials, approval by email is sought by a member of the R & D Team from Rachel Scofield
Works mainly on Haematology and Cardiology multi-centre portfolio adopted studies. Any other support required to be negotiated through R&D Manager
External statistician paid on a per project basis [email protected]
Management Support e.g. Finance, Legal Services, Archiving
Details of any internal agreement templates
[email protected] Geraldine Landers R&D Manager identified as the Trust R&D Archivist. See Archiving SOP
[email protected] National templates used
External contract for the Archiving of Closed Clinical Trials Files
Contact email
Details of any internal agreement templates Contact email
There are no internal agreement templates, where radiology support is required for trials, approval by email 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
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
[email protected] None
National Research Passport documentation [email protected]
Organisation R&D Interests
Information on the areas of research interest to the Organisation
Area of Interest Details Contact Name Contact Email Contact Number
Recruitment into multi-centre portfolio adopted research in
Haematology 01895 279796
Other Cancers 01895 279021
Paediatrics and neonatal research
Other non cancer studies
Ophthalmology
Stroke
Reproductive Health and Childbirth Dr Shruti Mohan
Cardiology and diabetes
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Information on Local / National Specialty group membership within the Organisation which has been shared with the NIHR CRN.
National / Local Specialty Group Contact Name Contact Number
NIHR CRN: North West London Dr Richard Kaczmarski 01895 279796
NIHR CRN: North West London Dr Sheena George 01895 279611 and 01895 279549
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Dr Richard Kaczmarski
Alexandra Diaz Predominately Multi-centre portfolio adopted studies
undertaken
01895 238282 Ext 2597
[email protected] Predominately Multi-centre portfolio adopted studies
undertaken commercial and non commercially funded Cancer [email protected] Contact Email 01895 279987 01895 279021 01895 279611 and 01895 279549 Natahsha Mahabir Organisation R&D Areas of Interest
Specialty Group Membership (Local and National)
Specialty Area (if only specific areas within group)
Ophthalmology
[email protected] [email protected]
[email protected] Predominately Multi-centre portfolio adopted studies
undertaken
Sheena George
Outer North West London Trusts
01895 279021 Alexandra Diaz
Dr Richa Ajitsaria
Multicentre portfolio adopted studies undertaken Predominately Multi-centre portfolio adopted studies undertaken
[email protected] [email protected] Predominately Multi-centre portfolio adopted studies
undertaken commercial and non commercially funded
Predominately Multi-centre portfolio adopted studies undertaken commercial and non commercially funded
01895 279021 [email protected]
[email protected] Melinda Holden
Organisation R&D Planning and Investments
Area of Investment
(e.g. Facilities, Training, Recruitment, Equipment etc.) Training
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Description of Planned Investment
Compliance with ICH GCP guidelines Value of Investment
Contact R&D Manager In-house ICH GCP Training electronic, and face to face in groups and one to one for both CTIMPS and
non CTIMPS/informed consent
Indicative dates Planned Investment
Organisation R&D Standard Operating Procedures Register
Standard Operating ProceduresSOP Ref Number Valid to
SOPV2 31.07.15 SOPV4 31.07.15 SOPV2 31.07.15 SOPV2 31.07.15 SOPV2 31.07.15 SOPV2 31.07.15 SOPV2 31.07.15 SOPV3 31.07.15 SOPV2 31.07.15 CT1 - CT24 31.12.15 Policy V1 31.12.2015
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Information on the processes used for managing Research Passports
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Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes
SOP Details Valid from
01.08.13 01.08.13
Archiving and Destroying Documents Trusts Research SOP's for researchers 01.08.13
SOP Title
01.08.13 Taking Informed Consent
Audit for Research Governance Purposes and Study
Monitoring Trusts Research SOP's for researchers
Trusts Research SOP's for researchers Case Record Form (CRF) Completion
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. 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 emails 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.
01.08.13
01.08.13
01.08.13
01.08.13
2.11.09 - 01.04.10
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
01.08.13 Definition of Responsibilities
Study Files and Filing
Pharmacy SOP's
Trusts Research SOP's 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 are currently being reviewed and will be updated by the expiry date.
01.12.2011 Trusts Research SOP's for researchers
Trusts Research SOP's for researchers
Trusts Research SOP's for researchers
Trusts Research SOP's for researchers
Trusts Research SOP's for researchers
Research Governance Policy
Preparation for Inspection by the Regulatory Authority
Adverse Event Reporting
Audit for Research Governance Purposes and Study Monitoring
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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.
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Other Information
For example, where can information be found about the publications and other outcomes of research which key staff led or callaborated in?
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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
