north thames lcrn transition plan to 1 april 2014 draft...

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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

E: [email protected]

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


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.


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


Agreement on appropriate Partnership Group membership – interim membership and consultation with all Partners.

3 Establishment of LCRN Leadership Team


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.


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


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


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.


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


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


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.


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


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


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.


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


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


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.


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


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


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.


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


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


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.


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


HR consultations delayed and subsequent delay in form decisions over Network Core management posts –

interim planning

10 Establishing robust financial managements arrangements


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.


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


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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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


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


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


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.


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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


None noted

13 Transitional arrangements for ensuring Information Governance Standards


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.


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


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

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• 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.

18

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

19

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)

20

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.

21

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.

22

NHS Permission CEL Infrastructure

24

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).

25

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

26

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.

north thames lcrn transition plan to 1 april 2014 draft...

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