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North Thames LCRN TRANSITION PLAN TO 1 APRIL 2014 Draft Version 0.3
Host Organisation: Barts Health NHS Trust
Partner
Organisations:
(NHS Trusts only)
1. Barking, Havering And Redbridge University Hospitals NHS Trust
2. Barnet And Chase Farm Hospitals NHS Trust
3. Barnet, Enfield And Haringey Mental Health NHS Trust
4. Basildon And Thurrock University Hospitals NHS Foundation Trust
5. Camden And Islington NHS Foundation Trust
6. East London NHS Foundation Trust
7. Great Ormond Street Hospital For Children NHS Foundation Trust
8. Hertfordshire Community NHS Trust
9. Homerton University Hospital NHS Foundation Trust
10. Luton And Dunstable Hospital NHS Foundation Trust
11. Mid Essex Hospital Services NHS Trust
12. Moorfields Eye Hospital NHS Foundation Trust
13. North East London NHS Foundation Trust
14. North Middlesex University Hospital NHS Trust
15. Royal Free London NHS Foundation Trust
16. Royal National Orthopaedic Hospital NHS Trust
17. South Essex Partnership University NHS Foundation Trust
18. Southend University Hospital NHS Foundation Trust
19. Tavistock And Portman NHS Foundation Trust
20. The Princess Alexandra Hospital NHS Trust
21. The Whittington Hospital NHS Trust
22. University College London Hospitals NHS Foundation Trust
23. West Hertfordshire Hospitals NHS Trust
Other affiliated
partners identified:
1. NHS Hertfordshire Valleys CCG
2. NHS Luton CCG
3. NHS Mid Essex CCG
4. NHS Thurrock CCG
5. NHS West Essex CCG
6. NHS Basildon and Brentwood CCG
7. NHS Castle Point, Rayleigh and Rochford CCG
8. NHS Southend CCG
9. NHS Barking & Dagenham CCG
10. NHS Barnet CCG
11. NHS Camden CCG
12. NHS City and Hackney CCG
13. NHS Enfield CCG
14. NHS Haringey CCG
15. NHS Havering CCG
16. NHS Islington CCG
17. NHS Newham CCG
18. NHS Redbridge CCG
19. NHS Tower Hamlets CCG
20. NHS Waltham Forest CCG
21. City University
22. Queen Mary, University of London
23. London School of Hygiene & Tropical Medicine
NIHR CRN: North ThamesNIHR CRN: North ThamesNIHR CRN: North ThamesNIHR CRN: North Thames
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24. University College London
Host Accountable Officer for the LCRN
Name: Peter Morris, CEO Email: [email protected], Tel: 020 7092 5466
Transition Facilitation Lead for the LCRN
Name:
Kristina Duggleby
West London Cancer Research Network Manager and Local
Transition Facilitation Lead, (North Thames)
National Institute for Health Research Cancer Research
Network (NCRN)
Level 6, Room 6L 28 Lab Block
Charing Cross Hospital
Fulham Palace Road W6 8RF
Tel: 020 3313 0289
M: 07825826639
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1 Engagement with existing clinical staff, Partner Organisations and Stakeholders
Progress already made
Regular meetings have taken place with all Network Lead Clinicians and Research Network Managers across the
CRN: North Thames geography. Transition presentations have taken place at various meetings to update key
stakeholders on progress to date and future plans. This includes both Central and East London (CEL) Executive
Board, Essex & Herts CLRN Board, CEL Pilot Hub Leads Meetings, CEL Pilot Divisional Meetings as well as
meetings at request. West Anglia CLRN Board members (representing Luton & Dunstable University NHS
Foundation Trust)were invited to be members of the Transition Strategy Group and regular communication over
staff resource requirements have taken place.
A Communication and Engagement Strategy was agreed to assist with planning and prioritisation of key events
needed to ensure that all Partners were updated on Transition. This included the following:
• R & D Stakeholder Event with representation from all 24 Trusts. The agenda and workshop feedback is
included at Appendix 1
• Planning of a Network wide Stakeholder Event for up to 250 network staff
• Regular Updates sent to all Partner organisations and stakeholders for further circulation
• Development of the CRN: North Thames portal space on the NIHR Website to assist with sharing of
documents, minutes of meetings and calendar to show future meetings. Links to access documents and
portal training being circulated and provided by existing Network staff
• A series of Divisional Clinical Leadership meetings in CEL Pilot have been extended to include relevant
research staff across the whole CRN: North Thames geography
Actions planned for 2013-14
Second R & D Stakeholder Event in January 2014 Transition Team* Dec 2103
CRN: North Thames Launch Event in March 2014 Transition Team Jan 2013
Further development of NIHR CRN: North Thames portal space Transition Team ongoing
Clinical Leadership Engagement Event CD (once appointed) Dec 2013
Continuation of the various workstream activity Transition Team then
COO (once appointed)
Mar 2014
Update of UCLPartners NIHR webpage Transition Team Mar 2014
*The Transition Team includes the Host R & Director and Project Manager, the Host Transition Lead, the NIHR Transition
Lead and support from existing Network staff (when required) and CEL Project Manager.
Risks identified and mitigations planned
Insufficient and inadequate communication to all Partners – regular and informative updates and
bi-weekly Host Newsletter
Partners not receiving communications and updates – extensive circulation lists produced
2 Transition to LCRN Governance Arrangements
Progress already made
A priority has been to establish the key Groups to support the establishment of the CRN: North Thames and ensure
that all Partners have a voice. A Transition Strategy Group (interim Executive Group) was formed once the Host was
announced and comprises of Clinical Directors and Chairs of both CEL and Essex & Herts CLRN, UCLPartners, the Host
Executive and R & D Director and the NIHR Transition Lead. This Group has CEO representation from two Partner
Trusts and has been fundamental in providing leadership and agreement across the LCRN.
It was agreed that a sub-group of UCLPartners’ Executive Group would act as the CRN: North Thames
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Partnership Group. Membership and NIHR ToR have been reviewed and agreed as interim but the existing UCLP
Executive Group ToR will need amending to include all Trusts across the geography, primary care and lay
representation. The scheme of delegation, assurance framework, risk management system and the escalation
process have been considered. The Governance arrangements have been agreed at the Partnership Group and
attached at Appendix 2.
A Host Operational Management Group has been established to determine key workstreams and review
progress on transition. A Network Operational Group has also been established with representation from all
Networks who deliver a research service within the CRN: North Thames geography. This was to ensure that all
Network staff had opportunity to engage with Transition.
Actions planned for 2013-14
Partnership group representation from Primary Care, Commissioning
organisations and lay people to be agreed
Partnership
Group Chair
Feb 2014
Partnership Group to agree minimum quorum levels Partnership
Group Chair
Feb 2014
The scheme of delegation, assurance framework, risk management
system and escalation process to be finalised
Partnership
Group Chair
Feb 2014
Partner organisations to set and agree the performance goals for
2014/15with the Host. These should be ambitious
Executive
Group/Partners
Mar 2014
The Partnership Group and Host Trust Board to agree the Business Plan
and Financial Plan for 2014/15
PG Chair/CD/ED Feb 2014
CD/CDs to Chair and formally establish the CRN: North Thames
Executive Group and agree membership/quorum levels
CD/CDs Dec 2013
Risks identified and mitigations planned
Agreement on appropriate Partnership Group membership – interim membership and consultation with all Partners.
3 Establishment of LCRN Leadership Team
Progress already made
The Accountable Officer of CRN: North Thames is Peter Morris, CEO. Barts Health NHS Trust Board have
delegated authority to Professor Joanne Martin, Director of Academic Health Sciences, to act on behalf of the
Host as the Executive Director for CRN: North Thames. The CRN: North Thames Clinical Director (CD) role outline
was reviewed and approved by the Transition Strategy Group (interim Executive Group) with an interview date
of 22nd November. The post was advertised widely and available on the NIHR, UCLPartners' and NHS jobs
website. A Stakeholder Panel, prior to interview, has been co-ordinated and will be Chaired by the COO of
Anglian Ruskin Health Partnership (ARHP).
The CRN: North Thames COO post has also been advertised widely and available on the NIHR, UCLPartners' and
NHS jobs website. Interviews are planned for the week beginning 16th
of December and will include the newly
appointed CD.
It is hoped that both key roles will have appointments and ideally be in post by the 1st
January 2014.
Actions planned for 2013-14
Develop the Business Plan for 2014/15 CD/COO/Host Feb 2014
Develop the Finance Plan for 2014/15 CD/COO/Host Feb 2014
Support the handover of work completed by the Transition team and workstreams COO Mar 2014
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Continue to provide planning and project support to the CD and COO Transition
Team
Mar 2014
Risks identified and mitigations planned
Failure to appoint to the CD or COO positions – advertise again
Delay to start date of COO position due to notice period – further support required from the LTFL and transition team.
4 Transition to LCRN Management Arrangements
Progress already made
Information about the workforce and mapping to specialty and Trust/s location has been carried out
across the LCRN geography. This information is currently being used to inform a consultation with
partner organisations about the LCRN set up and possible organisational structures. Any emerging
options will be costed to assist the Host, Partnership Group and Leadership team with agreeing a
preferred model.
This has been developed to assist the LCRN Host in developing a structure that can deliver on
expectations of the LCRN contract. Also, so that it can achieve the expected performance whilst
providing a robust assurance framework for the Partnership Group. This will include some assurances
that appropriate professional management for all LCRN funded staff is considered in all partner
organisations. An optional model will be presented to the Transition Strategy Group on the 18th
November, feedback and wider engagement will be used to inform the local transition HR consultation
process. The model has been developed with consideration of the key functions and requirements within the
Performance and Operating framework and these are included at Appendix 3.
The HR consultation cannot begin until a preferred model is agreed by all stakeholders and the Key
appointments are in place. Lessons learnt from the CEL LCRN Pilot Report will be incorporated.
The current model does not include detail of research delivery infrastructure at an individual trust level.
Job titles and WTE are provisional and for consultation purposes. There is no expectation that existing
research support staff will need to change their current employer or transfer to the LCRN Host.
Consideration has been given to incorporate some of the proposed remits into existing research
delivery roles, any such arrangements will be supported through formal agreements between the LCRN
Host and relevant employer.
Clinical Research Specialities
Clinical research specialties have been established within the CEL Pilot but these currently do not match to the
NIHR preferred Divisions. Extensive research support has been provided to all Specialties within CEL and has
been extremely beneficial in developing a ‘new’ research enthusiasm.
Research Delivery Divisions
Research Delivery Divisions have been established within the CEL Pilot but these currently do not match the
NIHR preferred model. A divisional management team was established and were responsible for the
development of the divisional spending plan. Clinical Enabling Groups (CEGs) have been added to the CEL Pilot
Divisional model to provide specialty-related knowledge to aid strategic development. Invitations to attend the
CEG Meetings have been extended to the Specialty Leads and Managers within Essex & Herts.
Research Delivery Cross-Management Teams
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Information gathering and options have been discussed and will be formally consulted and agreed once the CD &
COO are in post. The model will be developed with consideration of the key functions and requirements within
the Performance and Operating framework and lessons learnt from the CEL LCRN Pilot Report.
LCRN Support Team
Information gathering and options discussed and will be formally consulted and agreed once the CD & COO are in post.
LCRN Management Groups
An interim Executive Group has been established with representatives for CEL and Essex & Herts CLRN Chairs and CDs,
the COO of UCLPartners, The Host Executive Officer and R & D Director as well as the Local Transition Facilitation Lead.
Actions planned for 2013-14
Once the CD and COO are appointed a plan will be developed to
move the Divisions into the NIHR preferred model
CD/COO (once
appointed)
Mar 2014
Establish a Clinical Leadership Group (once CD appointed) which
might be at a Divisional level meeting quarterly and an Annual
Clinical Leadership Event across all Specialties
CD Jan 2014
All Research leadership appointments will be extended across the
whole geography of the CRN partnership eg: Specialty Leads
CD/COO Mar 2014
The Research Delivery and Industry Manager role outlines to be
submitted for AfC banding.
Transition Team Dec 2014
R & D Advisory Group from CEL LCRN Pilot to be extended to
include all CRN: North Thames geography. ToR to be agreed
CD/COO/ Transition
Team
Dec 2014
Risks identified and mitigations planned
Delays in moving to the NIHR preferred Divisional model- early planning with CD and COO
5 Transition of Research Delivery functions to ensure delivery of functions required in Performing
and Operating Framework
Progress already made
A Research Delivery Workstream has been established with representation from CEL and Essex and Herts CLRN,
Topic Network Managers, the Host Transition Team and the LTFL. A joint paper has been produced exploring the
existing models and options for future delivery and is attached at Appendix 4.
Within CEL LCRN Pilot a new process for delivery of NHS Permissions was piloted firstly for commercial research
and then from August 2013 for all NIHR studies. Four permission centres were established to provide an NHS
permission service to CEL member organisations based upon the Harmonisation principles, including study wide
review. Collaborative working with the Divisional Teams to produce evidence of feasibility and costing and
contract review were key to the success of the process. Lessons learnt from the Harmonised process in CEL LCRN
Pilot and key requirements in the Performance and Operating Frameworks (version 0.5) are being considered in
future planning for CRN: North Thames.
Actions planned for 2013-14
Formal agreement by the Partnership Group on the preferred
model for Research Delivery Functions in CRN: North Thames
CD/COO (once
appointed)
Jan 2014
To agree the principle of working towards the role out of a
harmonised process with single sign-off throughout the geography
CD/COO (once
appointed)
Feb 2014
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attributed to CRN: North Thames
Agreement on the number of Permission Centres required to
provide a service to all Partners in CRN: North Thames
CD/COO (once
appointed)
Feb 2014
Implement the functions of supporting research ideas and study
development and planning into future Research delivery services
CD/COO (once
appointed)
Feb 2014
Develop a CRN Industry Strategy and implement across the
Divisional structures
COO/Industry Manager
(once appointed)
Feb 2014
Risks identified and mitigations planned
Agreement on levels of support required in Trusts as opposed to centralised Permission Centres – consult and
gain agreement from Partners
6 Transitional arrangements for Patient, Carer and Public Involvement and Engagement
Progress already made
Consideration and discussion have taken place around the PCPIE strategy. Attendance at the PCPIE Strategy
Regional Leads workshop has informed development of the local strategy. The Host has recognised that they
have a key duty to promote research opportunities and deliver a work plan with measurable targets for ensuring
that patient choice, equality and diversity, experience, leadership and involvement are integral to all aspects of
LCRN delivery. Within the CEL CLRN Pilot an outline strategy was developed. This recommended representation
in the Divisional structures with associated terms of reference for lay members; provision of a PCPIE research
training day for patients and carers and support for a cross divisional online patient group.
Contact has been made with UCLPartners’ about a coordinated approach encompassing the CLAHRC.
Actions planned for 2013-14
A joint event between CLARHC, LCRN and UCLP leadership teams to
involve all existing patient groups with the aim of developing a joint
programme moving forwards
Transition
Team
Jan 2014
Establish the CRN: North Thames PCPIE workstream with
representatives across the Network
Transition
Team
Dec 2014
CRN: North Thames to start using ShareIT portal to collate PPI activity
within the new geography
Host Jan 2014
Development of a PCPIE Strategy to reflect on recent research
experience surveys and success of PCPIE Champions and Patient
Ambassadors in Trusts
Transition
Team
Mar 2014
Appointment and development of a designated post within CRN: North
Thames to co-ordinate events, communicate activities, share good
practice and to maintain the momentum
CD/COO (once
appointed)
Mar 2014
Establish the importance of PCPIE within CRN: North Thames with
strong leadership and commitment to the Strategy
CD/COO (once
appointed)
Mar 2014
Risks identified and mitigations planned
Failure to develop the PCPIE Strategy as other critical workstreams take priority – identify key individual to lead
the workstream
Appointment to key post is delayed – prioritise collation of job descriptions
Appointment is from within existing Network teams rather than a dedicated person with passion and interest-
consider key criteria required for the post
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7 Transitional arrangements for Continuous Improvement in relation to LCRN activity
The approach taken by the North Thames Transition Operations Team is based on the following principles
• Building on good practice already in place in NIHR CRN LRNs;
• Engagement of expertise from existing LRNs and R&D staff from partner organisations;
• Engagement of investigators and wider research support workforce from across the North Thames area
to ensure the future CRN service delivers high quality service and is responsive to their needs;
• Documenting what works well, highlighting any emerging risks to services and logging issues arising;
• Consulting experts on matters relating to HR, Managing Change, Information Systems and Finance;
• Support on-going initiatives and staff who already contribute to national schemes and workgroups for
continuous improvement during the transition and beyond
Progress already made
All Networks within the CRN: North Thames contribute to the local transition process strategically and
operationally. All have great expertise in managing change and service improvement, which puts the CRN at
some advantage with regard to approaches to continuous improvement and service development:
• CEL CLRN Pilot has been a national cornerstone demonstrating commitment to continuous improvement
and innovation. The now tested models of managing a significant change, working in Divisions, engaging
clinical specialties, NHS Permission centres and implementing a single LPMS system have all offered
significant learning. The full report from the CEL Pilot has been fed into the Transition Board, shared with
CEL stakeholders and will inform future planning.
• E&H CLRN has been a flagship for several Productive CLRN Service Improvement and Workforce Capacity
and Competency Development Programmes. These programmes include Business Intelligence Systems,
Workforce Development, LEAN and behavioural change approaches to service re-design and improvement.
The CLRN also operates a range of stakeholder surveys and needs assessments. These programmes were
developed in conjunction with The King’s Fund and taken forward in collaboration with the local NHS
Providers and Topic LRN, with recommendations being fed into all aspects of the national plans for the new
NIHR CRN.
Actions planned for 2013-14
Identification of a senior leader for continuous improvement within CRN:
North Thames. This is likely to be part of a Research Delivery Managers role
CD/COO Jan
2014
The Continuous Improvement (CI) Lead will establish links and participate
with nationally agreed continuous improvement initiatives
CI Lead (once
identified)
Mar
2014
The Host will continue to promote and sustain a culture of innovation and
continuous improvement
CD/COO (once
appointed)
Jan
2014
Continuous improvement knowledge and skills will be incorporated as a
core competency for all Network staff and be embedded into the
Workforce Development strategy
WD
workstream
Mar
2014
Risks identified and mitigations planned
Delay in HR consultation and subsequent delay in identification of Continuous Improvement Lead – establish a
workstream of key individuals to consider future plans to support the CRN Leadership Team
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8 Transitional arrangements for Workforce Development
Progress already made
A workstream has been established to support workforce development across CRN: North Thames; this has
incorporated interested staff from across the geography. This has its first meeting planned for November 2013
and will incorporate CEL LCRN Pilot and all other existing learning from across the geography. CEL LCRN Pilot
developed a workforce development strategy and agreed the following key principles:
• Develop a workforce focussed on corporate objectives and patient priorities and with the skills and
innovation needed to exceed on expected research delivery and governance targets.
• Promote the benefits of a workforce strategy to all staff working for CEL LCRN and encourage
stakeholder engagement and develop a research community
• Monitor and evaluate the impact of workforce development to help determine if this improved staff
retention and job satisfaction
To date they have supported 4 staff Induction training sessions with 108 attendees to introduce the workforce to
NIHR historical perspectives, transition, PCPIE, Research Management and Governance, NIHR performance
management principles and opportunities for further training. The feedback will be used to support future strategy.
Actions planned for 2013-14
Continuation of CEL LCRN Pilot planned workforce development (WD)
activities that include generic staff induction training
CEL LCRN Team On going
Establish a CRN: North Thames Workforce Development Strategy WD workstream Feb 2013
Identification of a senior leader for workforce development within CRN:
North Thames. This is likely to be part of a Research Delivery Managers role
CD/COO (once
appointed)
Jan 2014
The workforce development (WD) Lead will establish links and participate
with NIHR CRN Learning and Development programmes
WD Lead (once
identified)
Mar 2014
The Host will ensure that all CRN: North Thames funded staff have
appropriate line management arrangements in place and have
opportunities to undertake learning and development
WD Lead (once
identified)
Mar 2014
Develop a Workforce Plan in collaboration with LETBs, UCLPartners’ and
other training providers for LCRN staff to enable a responsive and flexible
workforce to deliver the NIHR CRN portfolio studies.
WD Lead (once
identified)
Mar 2014
Risks identified and mitigations planned
Delay in HR consultation and subsequent delay in identification of Workforce Development Lead – establish a
workstream of key individuals to consider future plans to support the CRN Leadership Team
9 Establishing robust Corporate Support Services for the LCRN
Progress already made
The Host Board are aware of their responsibility to ensure that the needs of the LCRN are addressed by those
with corporate responsibility for the provision of the infrastructure required by the Network to deliver its
operational remit. Space has been identified to host the Core Management team at the Mile End site within
Barts Health NHS Trust. Until the appointment of the CD and COO and subsequent approval by the Partnership
group the exact details of the Core Team establishment are not confirmed.
A Finance Lead for the Host has been appointed and in place from the 14th
November and will provide dedicated
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and timely financial support.
The named senior HR representative at Bart’s Health has been named as Emily Hendon.
Actions planned for 2013-14
A survey to be carried out of existing workspace Transition
Team
Dec 2013
The Finance lead to develop a system for financial management and
reporting
Host/Finance
Lead
Mar 2014
The Host to establish appropriate Governance, risk and assurance
arrangements and information governance to support the function and
establishment of CRN: North Thames
Host Mar 2014
Space developed for the Core Management Team Host/CD/COO Jan 2014
Risks identified and mitigations planned
HR consultations delayed and subsequent delay in form decisions over Network Core management posts –
interim planning
10 Establishing robust financial managements arrangements
Progress already made
Work has commenced to re-structure current CEL CLRN accounts to reflect the Pilot divisional structure. This will
need to be amended to reflect the final NIHR Divisional structures.
Actions planned for 2013-14
The Host organisation, through the LCRN Executive Team will draw up an
annual financial plan. This must ensure value for money
CD/COO/Finance
Lead
Feb
2014
Establishment of separate, ring fenced account, managed by the Trusts
Joint Research Management Office
Finance Lead Jan
2014
Funds will be managed in line with the Trusts SFIs and expended
according to the budgets laid down by NIHR CRN CC
Finance Lead Mar
2014
The Host will put measures in place to provide assurances that LCRN funding
provided to Partner organisations is used solely for these purposes
Finance Lead Mar
2014
The Host will establish a Finance training plan to provide training on the
CRN Finance tool and financial management to all Partner organisations
Finance Lead Mar
2014
Establishment of delegation powers under Barts Health SFIs to empower
the CD and COO to manage financial transactions for CRN: North Thames
Host Jan
2014
Risks identified and mitigations planned
No identified finance Lead – appointed but awaiting confirmed name and start date
11 Transitional arrangements for ensuring required Information Systems are put in place
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Progress already made
CEL CLRN Pilot established and implemented a Local Portfolio Management System across the CEL geography.
Lessons learnt will be incorporated into future planning in CRN: North Thames.
An Information Systems workstream is in set up and will have representatives from across the geography of
CRN: North Thames including representation from the CEL LCRN Pilot LPMS Group. This group will review the
current systems in place across the geography and make recommendations to the Executive and Partnership
Group once the CD and COO are in place. Finance and HR systems within the Host need to accommodate the
functions and workings of CRN: North Thames
Actions planned for 2013-14
The host to make plans on the development and remit of a dedicated Business
intelligence function to provide LCRN information and data analysis
Host/CD/COO Feb 2014
The host to develop a plan to procure and implement a Local Portfolio
Management System (LPMS) that conforms with the NIHR CRN LPMS
System of Choice Framework
Host/CD/COO Feb 2014
The Host to provide access to an LPMS across the LCRN Host/CD/COO Mar 2014
The Host to undertake a Business Acceptance Test of the LPMS prior to full
operational role out.
Host/CD/COO Mar 2014
The Host to provide IT equipment to the core management team Host Mar 2014
The Host to ensure that all LCRN funded staff have access to IT and
appropriate systems to enable them to fulfil their role.
Host Mar 2014
Develop plans for the establishment of a CRN: North Thames service desk
and associated working practises.
CD/COO Mar 2014
Risks identified and mitigations planned
Lack of agreement on a single LPMS across the CRN: North Thames – consultation and agreement through the
Partnership Group.
Procurement and implementation costs excessive – monies to be identified from Host allocation.
Procurement process and associated implementation is slow and not in place by the required time – early
planning and resource allocated to support implementation and training.
12 Transitional arrangements for Communications support
Progress already made
A workstream has been established to provide communication support across CRN: North Thames; this has been
developed from existing skilled staff from across the geography. A key priority of the communication strategy
was to establish a shared workspace on the NIHR portal called CRN: North Thames. Both CEL and Essex and Herts
CLRN have uploaded documents to enable collaborative planning and develop joint proposals for future working.
This space has been shared and developed with the Strategy Group (interim Executive Group) and Partnership
Group with links provided to papers.
Further meetings are planned with UCLPartners’ and CLARHC to update the NIHR information on the UCLP
website and to provide a main space for all Partners to access current information and future plans. This will
have links to relevant documents.
Actions planned for 2013-14
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Establish an identified Communications Lead that reports to the CRN:
North Thames Executive
CD/COO (once
appointed)
Feb 2014
Develop a communication’s Delivery Plan that meets the expectations
of the LCRN Contract and its Partners
Communications
Lead
Mar 2014
Support the role out of the NIHR CRN: North Thames branding and
associated documents
CD/COO(once
appointed)
Feb 2014
A CRN: North Thames Webpage to be developed on UCLPartners site and
links provided to all 24 Trusts and other stakeholders in the geography.
Communications
workstream
Jan 2014
Continuation of Bi-weekly Newsletters to all member organisations Communications
workstream
On going
Further refinement of the Communication Strategy once the CD and COO
are appointed to fully engage with Patients, staff and the general public
CD/COO(once
appointed)
Jan 2014
Risks identified and mitigations planned
None noted
13 Transitional arrangements for ensuring Information Governance Standards
Progress already made
All Trusts within CRN: North Thames undertake statutory mandatory training to comply with the Department of
Health Information Governance Toolkit. This ensures research staff take responsibility for collection, handling
and storage of date in an appropriate manner.
Actions planned for 2013-14
The Host to establish a process to ensure that all Partners and associated
research staff undertake Information Governance training and comply
with the standards in the Information Governance Toolkit.
Workforce
Lead/COO/
Partnership
Group
Mar 2014
Collection of Information Governance Toolkit scores for 2013/14 for
Trusts
COO (once
appointed)
Mar 2014
Develop a Plan to consider the following:
• Reporting process for low Information Governance Toolkit scores
• Reporting process for incidents for LCRN activities to CRN CC
• Process for sharing of commercially sensitive information
• Process for sharing information across organisations
COO (once
appointed)
Mar 2014
Identification of an Information Governance Lead within the Host Executive
Officer
Jan 2014
Risks identified and mitigations planned
Incidents for failure to comply with IG standards – remedial action plan to be established
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Plan approved on behalf of the Host Organisation Accountable Officer
Name: Professor Jo Martin Email: [email protected]
Tel: 02070925391
Role: Executive Director, CRN: North Thames
National Clinical Director of Pathology NHS England,
Professor of Pathology, Queen Mary University of London,
Director of Academic Health Sciences, Barts Health NHS Trust.
Signature:
Date: 22/11/13
Plan submitted by
(This is the person actually sending the report to the CRN Coordinating Centre and who should be contacted in case of any
technical/formatting issues with the plan only.)
Name: Kristina Duggleby Email: [email protected]
Tel: 07825826639
Role: CRN: North Thames Transition Facilitation Lead
Date: 25/11/13
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Appendix 1 R & D Stakeholder Event - The agenda and workshop feedback
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Appendix 2 Governance arrangements
CRN: North Thames governance functions
General Principles
The CRN exists to improve access to research for all patients across the UCLP geography, and in partnership
with UCLP, to promote the implementation of research into practice in alignment with the AHSN.
The governance principles below are in accordance with the recent guidance from NIHR.
Barts Health NHS Trust Board is accountable through this contract for the good governance of the CRN.
Barts Health NHS Trust Board shall apply, in a proportionate and appropriate way, the principles of good
governance and thereby promote:
• Robust, transparent and accountable CRN governance
• Effective and supportive CRN hosting arrangements
• Effective and proportionate contracts with Partners and other organisations in receipt of CRN
funding or resources
• A structure that ensures effective local performance management, Partner participation and
engagement, research delivery and value for money.
Scheme of Delegation and Host Board Controls and Assurances
• Barts Health NHS Trust Board shall agree a specific delegation of authority to the CRN Leadership
Team
• As part of the delegation to the CRN Leadership Team, Barts Health NHS Trust Board shall identify
and agree appropriate Board-level controls and assurances around CRN activities
• They must ensure the proper management of the CRN in terms of compliance with the governance
framework and processes of the Host, including human resources, standing financial, audit and
standards of business conduct instructions. The Host organisation shall ensure that internal policies
and standing financial instructions, as they affect the CRN, do not unreasonably diminish the
efficient management of the CRN.
Assurance Framework and Risk Management System
• The CRN shall develop and maintain an assurance framework and a risk management system
• The assurance framework will be scrutinised by the CRN Leadership Team at their regular meetings,
and shared with the CRN Partners at all Partnership Group meetings
• Annually, Barts Health must review its role in discharging the Department of Health contract for
hosting the CRN and provide a report on this within the CRN Annual Report. This report shall be
shared with the CRN Partnership Group
NIHR CRN: North ThamesNIHR CRN: North ThamesNIHR CRN: North ThamesNIHR CRN: North Thames
16
• The Host must ensure that CRN activity is included in the local internal audit programme
of work.
Escalation Process
• Barts Health NHS Trust shall implement and maintain a documented CRN escalation process
• Escalation routes and levels are:
– CRN Clinical Director;
– Host Organisation Executive Director for the CRN;
– Host Organisation Chief Executive Officer;
– Nominated contact in the national CRN Coordinating Centre.
The Partnership Group
• The Partnership Group will hold all NHS Trusts, and other research active NHS organisations,
including the Host, to account for research performance and transparency.
• It will review and agree CRN business plans and reports, including annual financial and business
plans, development plans and the Annual Report.
• It will be informed by financial and activity data, give active oversight and make a constructive
mutual challenge of CRN activity and performance, including delivery performance compared to
funding allocated
• It will monitor any compliance required of Partner organisations.
The Executive Group
• The Executive Group will ensure oversight and make management decisions about
CRN business
• It will formulate CRN strategy, and ensure it is guided by the CRN principles outlined in the
Operational Framework
• It will receive advice from, and liaise with, the Clinical Research Leadership and Operational
Management Groups on strategic and operational issues for the CRN
• It will oversee CRN performance against objectives, development and implementation of
performance improvement plans
• It will ensure patient, carer and public involvement and engagement is embedded in the activities
and structures of the CRN.
The R&D Advisory Group
The R&D Advisory Group will provide advice to the Executive Group (and above) on issues from the
perspective of Trust R&D offices. This will support the Executive Group’s work as set out above.
The Operational Management Group
The Operational Management Group will provide advice to the Executive Group (and above) on issues from
the perspective of the CRN’s Research Delivery Managers and Core team. This will support the Executive
Group’s work as set out above.
The Clinical Advisory Group
The Clinical Advisory Group will provide advice to the Executive Group (and above) on issues from the
perspective of the Speciality Themes. This will support the Executive Group’s work as set out above.
17
Accountable Officer
• The Chief Executive Officer of the Host organisation is the Accountable Officer for the CRN contract.
Nominated Executive Director
• Will act as the accountable individual between the Host organisation’s Board and the CRN; this
individual will be the line manager for the CRN Clinical Director
• The nominated executive director should not be the senior officer responsible for research
leadership within the Host Organisation; there must be a clear separation between accountability
for the CRN and accountability for the Host Organisation’s own research activities
• Will delegate responsibility to the CRN Clinical Director and CRN Chief Operating Officer for the
leadership, management and oversight of the CRN.
Clinical Director
• The Clinical Director shall be the senior officer, responsible for clinical leadership in the CRN,
engaging the wider clinical and research community (including local NIHR Faculty members),
promoting research and building clinical research capacity
• The Clinical Director may be employed by the Host organisation or one of the Partner organisations
within the CRN area, on condition that the provision of the Clinical Director and lines of reporting
and accountability are clearly set out in a documented agreement with the Host organisation.
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CRN: North Thames proposed extended governance structure
NIHR CRN
Co-ordinating Centre
Barts Health
NHS Trust Board
CRN: North Thames
Partnership Group
CRN: North Thames
Executive Group
CRN: North Thames
Operational
Management Group
Chair – CEO of member
Trust
Membership = Trust R&D
Directors or R&D Managers
CRN: North Thames
R&D Advisory
Group
CRN: North Thames
Clinical Leadership
Group
Chair – Clinical Director
Membership = Speciality
Theme Leads
Chair – Chief Operating
Officer
Membership = Research
Delivery Managers & Core Team
Frequency - quarterly Frequency - monthly Frequency - quarterly
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Appendix 3 Functions required from the Performance and Operating Framework
Research Delivery (including RMG) based on the Draft NIHR CRN Performance and Operating Framework 2014-15 v0.5
Supporting the research delivery pathway
Stage 1) Research ideas Stage 2) Study
Development & Planning
Stage 3) Study set-up and
start-up
Stage 4) Study Recruitment and
follow-up
Stage 5) Study Closure
• Early advice on study
design, study funding,
activity attribution,
costing and feasibility
• Study feasibility
• Set-up in NHS Support
Service Departments
(e.g. pharmacy,
radiology and
laboratories)
• Processing applications for
NHS Permission, (via CSP)
• Supporting other
regulatory approvals
• Allocation of NHS support
resources
• Other aspects of site set-up
and site initiation
• Identification and recruitment
of study participants
• Management of participants
and follow-up
• Collection of research data (as
defined in AcoRD)
• Collection of performance
management data
• Activities delivered
following the last
patient/ last visit through
to the archiving of the
study
Research Management and Governance
Use of NIHR Coordinated
System for NHS
Permission
Provision of clear and
consistent regulatory
advice
Set-up &management of
honorary research contracts
and letters of access
Provision of a Coordinated
Service to support the set-up and
delivery of research
Systematic approaches to
review and improve internal
processes
Quality, consistency and
customer services Streamlining through
reliance on assurances
Harmonised processes across
NHS Providers
Sharing of data and samples Note HRA Assessment and
Approval business case
Life Sciences Industry
Single point of contact Feasibility Study Delivery Promotion of Industry National Strategy
Notes
High Level Objectives: Recruitment (national 650,000) 2) Recruitment to Time and Target (80%) 3) Proportion of studies requiring MHRA authorisation delivered via NIHR CRN (75%), 4) Studies
gaining NHS Permission in 40 days from receipt of valid complete application (80%), 5) First patient first visit in 30 days from later of NHS Permission or Site Initiation Visit (80%), 6) NHS Trust
participation in NIHR CRN Portfolio Studies (98% NHS Trusts for any portfolio research, 70% for commercial portfolio research and primary care metric to be determined)
Objectives for Cross-cutting activities: 1) Customer (Host, participants, patients/ cares/ other etc) via survey and assessment, Financial (variance and return on time), Internal Business
Processes (upload data). Learning and Development (flexible and trained workforce), Promoting research participation and culture (all providers increase recruitment)
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Appendix 4 Research Delivery/RM& G Functions
Draft North Thames Transition Strategy Group: Options for Provision of RMG to support Study Delivery
Purpose To suggest options for the delivery of the National Institute for Health Research Coordinated System for Gaining
NHS Permission (NIHR CSP) in the North Thames CRN.
Background NIHR CSP is the national system used to provide ‘R&D Approval’ for studies on the NIHR Portfolio. The North
Thames CRN has options as to how best to deliver NIHR CSP. The chosen model should preserve and build upon the best
of pre-existing processes. It should support researchers to set up and successfully deliver research to time and target based on accurate local feasibility.
There are currently two models that are running across North Thames area (details in the Appendices 1 and 2)
• Integrated Research Offices based around NHS Trusts is a successful model in Essex and Hertfordshire (E&H).
• Central and East London (CEL) successfully operates a harmonised model, which partners R&D Offices,
clinical divisions and permission centres in undertaking coordinated reviews across multiple Trusts.
There are two main options:
Comments
1) Delivery
via Trust
R&D Offices
• Would provide continuity for existing E&H R&D staff but would require significant resourcing in the
majority of R&D offices across CEL not currently responsible for CSP.
2) Delivery
via
Permission
Centres
(PREFERRED
OPTION)
• Uses skilled staff working to a single standard and offering quick approval times for all research.
• Has a generally positive feedback from the stakeholders (Appendix 3).
• Streamlines processes involving medical exposure, costing, contracting and pharmacy review.
• Extends access to research to multiple Trusts under a single review.
Note When using this option, the impacts that need to be mitigated include :
• To deliver on DH '70 days' target, we would need to build on current models linking governance
checks and planning study/site initiation/ 1st patient recruitment, local feasibility.
• Re-allocation of functions and funding from R&D offices to Permission Centres to avoid duplication.
There are a
number of
choices
under
option 2
How many Permission Centres?
1a. Maintain 4 Permission centres with expanded
geographical remit.
1b. Increase to 5 permission centres.
1c. Have a single NHS Permission centre.
Who is responsible for local feasibility?
2a. CRN research delivery division (as per non-
commercial harmonisation in CEL).
2b. R&D staff in the permission centre/s,
supported by divisional staff (as per commercial
harmonisation in CEL).
2c.Continuation of the above two options, split by
commercial/non-commercial.
2d. Locally based staff (as per E&H model).
Core Team and Division responsibilities
3a. Continuation of a Lead RM&G core team functions,
in support of the industry operations manager,
retaining responsibility for allocation and performance
management of CSP reviews.
3b. Full devolution of responsibility for managing CSP
(under the Chief Operating Officer and Industry
Operations Manager) to the individual research
delivery divisions and permission centre/s.
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Details of the RMG Models across North Thames
NIHR CSP Arrangements (NHS Permission, Assurance and PIC Agreement)
Central and East London Comprehensive Local Research Network
CEL CLRN have ‘harmonised’ the way in which NHS Permission is undertaken1. Instead of multiple local R&D
reviews of the same study, UCLP Harmonisation provides a single review, and single permission, across multiple
CEL Trusts.
The aim of harmonisation is to eliminate red-tape, redirect resource to the front-line, deliver permission in a
speedy and efficient manner and ensure that as many Trusts as appropriate are opened to research without
duplication of review.
The UCLP harmonisation pilot concluded in May 2013, in which time 96% of harmonised permissions were
issued within 30 days. Harmonisation has now been implemented as the CEL CLRN delivery mechanism for all
NIHR CSP activity.
How Does it Work?
Instead of reviews being undertaken within the local R&D Office of the site/s where the research is to take
place, one of four permission centres is allocated the review, based on the clinical specialty of the study. The
permission centre, regardless of the number of sites within CEL, undertakes:
• One Costing and Contract Review (Max 30 days)
• Study Wide CSP Review (where CEL is the lead) (Max 30 days)
The core team of CEL CLRN coordinates
• One Medical Exposure Review (Max. 24 days)
• One Pharmacy Review (Max. 22 days)
All of the above apply to all CEL sites that are to undertake the study, no duplication is required.
In addition, the Clinical Divisions of the network are tasked with supporting the review by assuring that the
study is feasible at site (and suggesting additional sites where appropriate). For non-commercial research, this
local feasibility, undertaken by the clinical divisions, provides the information to satisfy the NHS Organisation
(Local) governance checks in RDMIS CSP Module. Local feasibility includes seeking local clinical department
authorisation for the study at each site.
When the review is complete, the NHS Permission letters and contracts are signed by the permission centre on
behalf of all local research sites. All CEL Trust CEOs have delegated their authority to the four permission centres
to sign non-disclosure agreements, site contracts and NHS Permission letters on their behalf.
1 Within CEL, harmonisation applies to ALL commercially sponsored research and all NIHR Portfolio non-commercial
research. Non-commercial, non-NIHR portfolio research remains a matter for local Trusts.
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NHS Permission CEL Infrastructure
23
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Essex and Hertfordshire Comprehensive Local Research Network
Approach to Support Researchers and Research Delivery
Purpose
To describe the approach developed by the Essex and Hertfordshire CLRN to deliver RMG so as to
inform a discussion on the development of the North Thames CRN.
Essex and Hertfordshire CLRN (EH CLRN) Approach
In EH CLRN there are 7 NHS Trusts that will become part of North Thames CRN. These Trusts are
supported by a single CLRN Integrated Research Delivery Office based at 7 locations. The activities at
each location are co-ordinated and supported by the Core Team which also provides a central RMG Hub
function.
Location Designated NHS Trust
• Basildon Basildon & Thurrock University Hospitals NHS Foundation Trust
• Chelmsford Mid Essex Hospital Services NHS Trust & Primary Care
• Laindon South Essex University Partnership NHS Foundation Trust
• North East London North East London Foundation Trust
• Southend Southend University Hospital NHS Foundation Trust & Primary Care
• Epping / Harlow Princess Alexandra Hospitals NHS Trust & Primary Care
• Watford / Hemel West Hertfordshire Hospitals NHS Trust
EH CLRN-funded staff work together as a network via Weekly Study Delivery teleconferences and
monthly Operational Management Group meetings. Whilst each location is primarily associated with
providing a service to their designated NHS Trust, the workload is managed between locations to ensure
optimum performance and also to ensure that each Trust has access to all of the CLRN-funded expertise.
Our approach has provided support to all specialties and Topic areas as there are no other networks in
the area other than Cancer.
The EH CLRN approach adds value rather than duplicating Trust R&D functions and has the following features:
• A 5 day a week research governance and delivery support service covering all sectors (Acute,
Mental Health, Primary care) using both clinical and non-clinical perspective with staff working to a
standard approach to ensure robust, speedy and cost effective research delivery.
• Provision of support to commercial and non-commercial research for study feasibility, set-up and
delivery.
• Research delivery to time and target based around feasibility, governance, site initiation and
management of recruitment performance through joint working of clinical and non-clinical CLRN-
funded staff.
• Completion of Study-wide checks, Local checks, Co-ordinated Network Support Service,
Management of Devolved Nation studies, Assurance to Primary Care, Processing of Amendments
and Patient Identification Centre (PICs) information, HR Good Practice (Research Passports), Advice
Service, Excess Treatment Costs
• Professional development for staff (including GCP and Proportionate & Pragmatic Training RMG
Training) and peer working (e.g. costing assurance).
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EH CLRN Integrated Research Delivery Model
EH CLRN Research Delivery Office Locations
Model to show staff and principal duties for the EH CLRN Core Team and CLRN-funded staff in Trusts
EH CLRN
Core
Team
• CLRN Research Delivery Lead Manager (Band 8b) – Overall study delivery performance management,
RMG Advice and professional support, supervision and development for RMG Staff
• CLRN Lead Research Nurse (Band 8a) – Co-ordination of Recruitment to Time and Target performance
monitoring, research feasibility and delivery advice, workforce competency development and
professional management.
• CLRN Life Sciences Industry Lead / Industry Manager (Band 8a) – Co-ordination of Industry Studies set up
and performance monitoring; production of monthly site specific performance statements
• CLRN Finance and Performance Manager (Band 7) – Costing support; monitoring of RIS scheme for
primary care; AcoRD Specialist
• CLRN CSP Lead (Band 7) – Delivery of NHS Permission and the EH CLRN local portfolio management
system.
Close working between EH CLRN Core Team and Integrated Research Delivery Office staff
employed and working in Trusts to provide the local delivery of a national service
Integrated
Research
Delivery
Offices
in Trusts
• RMG Facilitators (Band 7) – Study-wide and Local Checks (CSP Module), Costing of studies, Research
Passport and related activities, Co-ordinated Network Support Service, advice service.
• Site Co-ordinators (Band 7) – Senior clinical trial specialist responsible for co-ordination of the workload
within research delivery, local study feasibility and advice service; assessment of patient flows at a site,
advice service and support to SSI Form completion
• Research Nurses (Band 6) – Study feasibility (inc Assessment of patient flows at a site), use of site
intelligence to inform opening of a study set-up and delivery. Assessment of patient flows at a site,
advice service, support to SSI Form completion
• Data Managers (Band 5) – Local data entered onto national and local systems, monitoring of recruitment
target attainment. Occasional contribution to studies involving non-patient contact.
• Pharmacy, Radiology and Pathology staff – Contribute to internal capacity, supported via direct CLRN
payment.
• Use of standard costing template and research delivery manual
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EH CLRN Performance 2013/4 (April-Sept)
Study-wide Process NHS Permission
• Median 9.5 days, 100% in 30 Days • Median 15 days, 85% in 30 Days
RMG activity by EH CLRN for Trusts within North Thames CRN
• Study-Wide Process = 10 during 2011/2 and 2012/3
• NHS Permissions = 276 during 2011/2 and 2012/3
• Primary Care Assurance (based on a single assurance to cover Essex and Herts) = 56 studies in
2013/4 to date
• Amendments = 374 in 2013/4 to date
• Assessment of Patient Identification Centre information (PICs) = 37 during 2013/4 to date
• Research Passports / Letters of Access (138 during 2012)
A wide range of staff directly and indirectly contribute to the RMG process with 2013/4 EH CLRN
budget for N Thames CRN
• RMG Staff (approx. 7%), Site Co-ordinators (6%), Pharmacy (7%), Radiology and Pathology (4%), Data
Manager (4%), Research Nurse (38%)
Impact of the Transition
• Essex and Hertfordshire geographical and not based on Themes / Divisions.
• RMG and Study Delivery workforce rely on each other for expertise and provide a 5 day a week
service.
• Commercial and non-commercial studies managed via the same team (clinical and RMG).
• Workforce maybe fixed to locations but flexible in way of working; experienced in ‘functioning as a
single team’ and sharing workload if required.
• Primary Care RMG delivered via 3 Offices (Chelmsford, Southend and Epping) and payment of
service support directly to NHS Providers via Core Team. Issuing of governance assurance letters
which cover Study-wide and Local Checks and support to HR Good Practice (Research Passports) to
NHS Providers. High level of engagement with NHS England Local Area Teams and Clinical
Commissioning groups (CCGS). Processes in place for management of Excess Treatment Costs. Lack
of clarity going forward.