nihr guideline b01 research & development operational ......band 8b 30 hours/week funded by the...
TRANSCRIPT
NIHR Guideline B01
Research & Development Operational Capability Statement V 6 2017 - 18Updated March 20145
Version History
Version number Valid from Valid to Date approved Approved by Updated by
RDOCS 001 V6 01/05/2017 31/03/2018 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
Name 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:
Add further lines as required
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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
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
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Band 6 funded by NWL CRN ABF and CRN core funds (0.3WTE)
R&D Director & he is also a Cardiology Consultant
Band 6 funded by NWL CRN ABF, commercial research income and CRN core funds (0.4WTE)
Funded by the individual study centre
Band 6 funded by CRN core funds (0.6WTE)
R&D Team
Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details
Band 5 funded by NWL CRN ABF
Organisation Details
Comments
indicate if part time/full time/shared/joint etc
Band 8b 30 hours/week funded by the North West London (NWL) Clinical Research Network (CRN)
Contact 1:
Band 7 funded by NWL CRN Activity Based Funding (ABF) and by NWL CRN core funds (0.2WTE)
Dr Simon Dubrey
Band 7 funded by NWL CRN ABF and commercial research income
The Hillingdon Hospital
01895 279021
Contact 2:
Add further lines as required
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Research Networks
Research Network (name/location)
NIHR CRN: North West London
Add further lines as required
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Current Collaborations / Partnerships
Organisation Name
Informal - Brunel University
Brunel University
Add further lines as required
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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.
Role/relationship of the Research Network e.g. host Organisation
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.
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)
Pro-Vice Chancellor, Equality, Diversity and Staff Development
Professor of Rehabilitation. Member of Trust R&D Steering Group.
Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.)
01895 268755
Details of Collaboration / Partnership (e.g. University/Organisation Joint Office,
external provider of pathology services to Organisation, etc, effective dates)Email address
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
Contact Name Contact Number
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
Add further lines as required
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CCG ONLY: Information on the practices which are able to conduct research
Add further lines as required
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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
Licence Details Licence End Date (if applicable)
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
North West London Pathology Mark Busby
Sonia DeCastro
020 331 17100
Radiology Dr Ziad Meer
Dr Zarni Win
via ext. 3329
Pharmacy Andrew Caunce ext. 3722
Cardiology Alison Rochelle ext. 2601
01895 279021
Add further lines as required
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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 Humphreys Plus 01923 252447
Contracts Geraldine Landers 3021
Data management support Geraldine Landers 3021
Finance Suzanne King 3963
Information Technology IT Help Desk 4400
Legal Geraldine Landers 3021
Personnel Binu Arora 3418
Statistical support Paul Bassett 07905 530446
Management Support e.g. Finance, Legal Services, Archiving
Specialist facilities that may be provided (e.g. number/type of scanners)
Clinical Service Departments
General Pathology Services
General X-ray Services, MRI, CT, Ultrasound
General Pharmacy Services
There are no internal agreement templates, where
cardiology support is required for trials, approval by
email is sought by a member of the R & D Team
and discussed at the R&D Feasibility Meeting
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
and discussed at the R&D Feasibility Meeting
External statistician paid on a per project basis [email protected] National Research Passport documentation
None
We employ 1 WTE Data Manager who supports
cross-divisional multi-centre portfolio adopted
studies. Please contact R&D Manager for support
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
[email protected] National templates used
Details of any internal agreement templatesContact 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 De Zaid Meer or his deputy Dr Zarni Win and
discussed at the R&D Feasibility Meeting
There are no internal agreement templates, where
clinical trails pharmacy support is required, approval
by email is sought by a member of the R&D Team
and discussed at the R&D Feasibility Meeting.
Outsourcing of some services to Baxter's
Compounding unit at Mount Vernon Hospital
Compounding Chemotherapy Drugs for parenteral
use for the Haematological patients
External contract for the Archiving of Closed Clinical Trials Files
Contact email Details of any internal agreement templates
[email protected] Geraldine Landers R&D Manager identified as the
Trust R&D Archivist. See Archiving SOP
PLEASE NOTE: All contact must be made through Geraldine Landers R&D Manager
Add further lines as required
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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 Cancer 01895 279796
Other Cancers 01895 279021 or Ext
2826
Paediatrics and neonatal research
Other non cancer studies eg surgery
Critical Care 01895 279238
Anaesthesia
Ophthalmology
Stroke
Reproductive Health and Childbirth
Cardiology, diabetes, Venous Thrombosis Embolism (VTE)
Neurology contact via Geraldine Landers
Donated Paed equipment frm Durston House Ball – Richa/Sophie plaque/event/photo? – contact Richa for date for photo
Musculoskeletal, Rheumatology
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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
NIHR CRN: North West London Dr Richard Kaczmarski
NIHR CRN: North West London Dr Sheena George
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Dr Richard Kaczmarski
Mariam Nasseri
Melinda Holden
Multi-centre portfolio adopted studies undertaken
01895 238282 Ext 2597
Multi-centre portfolio adopted studies undertaken commercial and non
commercially funded
Specialty Group Membership (Local and National)
01895 279021 or Ext 2342
Cancer
01895 279611 and 01895 279549
Natasha Mahabir
Mariam Nasseri
01895 279987
01895 279021
Organisation R&D Areas of Interest
Contact Email
Dr Richa Ajitsaria
Specialty Area (if only specific areas within group)
Ophthalmology North West London Trusts
Multi-centre portfolio adopted studies undertaken
Multicentre portfolio adopted studies undertaken
Outer North West London Trusts
Multi-centre portfolio adopted studies undertaken
Multi-centre Observational portfolio adopted studies undertaken
Multi-centre portfolio adopted studies undertaken commercial and non
commercially funded
Elisa Kam
Multi-centre portfolio adopted studies undertaken
Multi-centre portfolio adopted studies undertaken commercial and non
commercially funded
Ext 2826
[email protected] Holden
Sheena George
Multicentre portfolio adopted studies undertaken
Multi-centre Observational portfolio adopted studies undertaken in Parkinson's,
MS and neuro rehab
Multi-centre Observational portfolio adopted studies undertaken
Dr Shruti Mohan
Dr Michelle Fernando [email protected]
Organisation R&D Planning and Investments
Area of Investment
(e.g. Facilities, Training, Recruitment, Equipment etc.)
Training
Add further lines as required
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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 Procedures
SOP Ref Number
R&D001 V1
R&D002 V1
R&D003 V1
R&D004 V1
R&D005 V1
R&D006 V1
R&D007 V1
R&D008 V1
R&D009 V1
R&D010 V1
R&D011 V1
R&D012 V1
R&D013 V1
R&D014 V 5
R&D015 V 5
R&D016 V 3
R&D017 V 4Preparation for Inspection by the Regulatory Bodies
R&D018 V 5
R&D019 V 4
R&D020 V 4
CT1 - CT24
Policy V1
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Information on the processes used for managing Research Passports
Add further lines as required
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SOP Details Valid from
30.06.17
Generation Issue and Control of SOPs New Trust Research SOP for Researchers
30.06.17
SOP Title
30.06.17
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
Study Archiving
New Trust Research SOP for Researchers
Trust Research SOP for Researchers
New Trust Research SOP for Researchers
Non-compliance Escalation Process
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. The letter
of access or the HRC is then emailed 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&D shared drive.
Currently redrafted and for review at the R&D
Steering Group and ratification by the Patient Safety
Committee
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
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
Trust Research SOP for Researchers 30.06.17
New Trust Research SOP for Researchers
Pharmacy SOP's
30.06.17
01.05.2017
30.06.17
Taking Informed Consent
Research Governance Policy
Study review of NHS ability to deliver
Study Monitoring and oversight
Honorary contracts and Letters of Access
Study Files and Filing
Training
Definition of Responsibilities
30.06.17
30.06.17
30.06.17
Template SOP
Case Record Form(CRF) Completion
30.06.17
30.06.17
Sponsorship Review of new studiesNew Trust Research SOP for Researchers
Serious Breach Reporting
Processing of Amendments
Closure of a study
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
New Trust Research SOP for Researchers
Host Site Feasibility Review of new studies
R&D File Set up and Maintenance
Pharmacovigilance reporting
30.06.17
30.06.17
30.06.17
Trust Research SOP for Researchers
Trust Research SOP for Researchers
Trust Research SOP for Researchers
Trust Research SOP for Researchers
Trust Research SOP for Researchers
30.06.17
30.06.17
30.06.17
30.06.17
30.06.17
30.06.17
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, 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 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.
Add further lines as required
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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.
Go to top of document
Other Information
For example, where can information be found about the publications and other outcomes of research which key staff led or collaborated in?
Add further lines as required
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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 and procedures,
Research SOP's Contact details, Staff publications and R&D Processes
Other Information (relevant to the capability of the Organisation)
Band 6 funded by NWL CRN ABF and CRN core funds (0.3WTE)
R&D Director & he is also a Cardiology Consultant
Band 6 funded by NWL CRN ABF, commercial research income and CRN core funds (0.4WTE)
Funded by the individual study centre
Band 6 funded by CRN core funds (0.6WTE)
R&D Team
Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details
Band 5 funded by NWL CRN ABF
Organisation Details
Comments
indicate if part time/full time/shared/joint etc
Band 8b 30 hours/week funded by the North West London (NWL) Clinical Research Network (CRN)
Contact 1:
Band 7 funded by NWL CRN Activity Based Funding (ABF) and by NWL CRN core funds (0.2WTE)
Dr Simon Dubrey
Band 7 funded by NWL CRN ABF and commercial research income
The Hillingdon Hospital
01895 279021
Contact 2:
This network encompasses all clinical specialities and provides funding to support the infrastructure and management of NIHR adopted clinical trials.
Role/relationship of the Research Network e.g. host Organisation
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.
Reporting Structures
01895 268755
Contact Number
Yes
Number/notes on General Practitioner (GP) Practices
NA
OTHER
yes
yes
Licence End Date (if applicable)
Management Support e.g. Finance, Legal Services, Archiving
Clinical Service Departments
There are no internal agreement templates, where
cardiology support is required for trials, approval by
email is sought by a member of the R & D Team
and discussed at the R&D Feasibility Meeting
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
and discussed at the R&D Feasibility Meeting
External statistician paid on a per project basis
National Research Passport documentation
None
We employ 1 WTE Data Manager who supports
cross-divisional multi-centre portfolio adopted
studies. Please contact R&D Manager for support
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
National templates used
Details of any internal agreement templates
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 De Zaid Meer or his deputy Dr Zarni Win and
discussed at the R&D Feasibility Meeting
There are no internal agreement templates, where
clinical trails pharmacy support is required, approval
by email is sought by a member of the R&D Team
and discussed at the R&D Feasibility Meeting.
Outsourcing of some services to Baxter's
Compounding unit at Mount Vernon Hospital
Compounding Chemotherapy Drugs for parenteral
use for the Haematological patients
Details of any internal agreement templates
Geraldine Landers R&D Manager identified as the
Trust R&D Archivist. See Archiving SOP
Donated Paed equipment frm Durston House Ball – Richa/Sophie plaque/event/photo? – contact Richa for date for photo
Contact Number
01895 279796
01895 279611 and 01895
279549
01895 238282 Ext 2597
Specialty Group Membership (Local and National)
01895 279021 or Ext 2342
01895 279611 and 01895 279549
01895 279987
01895 279021
Organisation R&D Areas of Interest
Ext 2826
Contact R&D Manager
Indicative dates
Planned Investment
Valid to
01.05.2019
3 years from release
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. The letter
of access or the HRC is then emailed 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&D shared drive.
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
2 years from release
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, 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 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.
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 and procedures,
Research SOP's Contact details, Staff publications and R&D Processes
Other Information (relevant to the capability of the Organisation)