Annual Plan

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CRN: [North East and North Cumbria] Annual Plan 2015-16

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Contents

Table 1

LCRN plans and goals for contributing to NIHR CRN High Level Objectives 2015-16

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Table 2

LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty Objectives 2015-16

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Table 3

LCRN plans against the Operating Framework 2015-16

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Table 4

LCRN Patient and Public Involvement and Engagement (PPIE) Plan 2015-16

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Table 5

LCRN Continuous Improvement Action Plan 2015-16

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Table 6

LCRN Workforce plan

6a – Learning and Development Plan

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6b – Workforce Intelligence Plan

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Appendix 1

Risk Register

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Table 1. LCRN plans and goals for contributing to NIHR CRN High Level Objectives 2015-16

Objective Measure CRN

Target

LCRN Goal

Specific key local activities for 2015-16 Timescale

1 Increase the number of participants recruited into NIHR CRN Portfolio studies

Number of participants recruited in a reporting year into NIHR CRN Portfolio studies

650,000

33,625  Clinical Research Leads (CRLs) and Research Delivery Managers (RDMs) worked with Clinical Research Specialty Leads (CRSLs) to agree goals for each Specialty by Partner Organisation (PO)

 Goals were informed by current studies, plus those known to be opening in 2015-16  Specialties encouraged to set stretch goals

N/A

 Monthly reporting of all recruitment metrics (LCRN performance report), reviewed by Executive Group.

 In depth review of all performance metrics at Executive Group (division/month)

Monthly

Monthly reporting of recruitment metrics to CRSLs – where recruitment failing development of local action plans, jointly developed by CRSL, RDM and POs

Monthly

2 Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time

A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites

80% 80%  Production of local monthly reports (open studies) to indicate RAG status and dissemination across Specialty, Divisions and PO

 Monthly review of open studies that are red or amber and production of a locally agreed action plan to address the issues

 Feedback to the national industry team errors and discrepancies for amendment e.g. omissions, incorrect dates and targets

 Liaison with sponsors or CRA where appropriate to facilitate action plans. Carried out by industry team and liaison with RDMs

Monthly

Development of new collaborative ways of working and enhancing recruitment to commercial studies e.g. Gastrointestinal collaborative working, training and development of PIC site strategy

Launch 29/01/2015 – pilot for 12 months PIC strategy – launched for 12 months. Completion April 2016 B: Proportion of non-commercial studies achieving or

surpassing their recruitment target during their planned recruitment period

80% 80%  Production of local monthly report to indicate RAG status and dissemination across Speciality, Divisions and PO

 Monthly review of studies that are red or amber

 Follow the agreed NENC workflow regarding recruitment to time and target to include a locally agreed action plan to address the issues

 Liaison with Sponsors where required to facilitate action plans. Carried out by PO, R&D dept. and RDM

Ongoing monthly

Review success of locally agreed workflow to address issues around recruitment to time and target and amend as necessary RTT workflow introduced 10/2014 for 12 months. For review April 2015 3 Increase the number of

commercial contract studies delivered through the NIHR CRN

A: Number of new commercial contract studies entering the NIHR CRN Portfolio

600 n/a  Industry team to work to sustain the development of new industry studies by promoting industry work, training and developing new staff/teams and liaising with POs within R&D and existing study team in new clinical areas

 Monitor this on a monthly basis via ODP and the industry RAG reports

Ongoing monthly

Development of MedTech initiative to increase interactions with SME and Med Tech companies to develop an increasing number of commercial research projects in conjunction with the AHSN and other regional services to support this sector

Pilot for 12 months – review

end October 2015  Industry team work to increase the number of sites in NENC involved in commercial research

studies by proactively promoting the commercial agenda and potential studies via POs, Clinical

Monitored on monthly basis –

Objective Measure CRN Target

LCRN Goal

Specific key local activities for 2015-16 Timescale

Research Specialty Groups (CRSGs) and directly with clinical teams

 Harmonise set-up activities for studies running at multiple sites in the region e.g. streamline Site Initiation activities, share and harmonise set-up activities

evaluation at 6 and 12 months

B: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II–IV studies

75% n/a  Industry team work with sponsors and site teams to encourage commercial research to be submitted as NIHR portfolio studies – interaction via Principal Investigator (PI), study teams, R&D departments and direct with companies to intervene at the earliest possible opportunity and promote the NIHR portfolio

 See also MedTech initiative as mentioned above in 3A

Ongoing – reactive to opportunities

Training given to PI and study teams about the merits of portfolio research to allow for early identification of these additional opportunities

PO level training via existing research meeting and attendance at SG meetings 4 Reduce the time taken for

eligible studies to achieve NHS Permission through CSP

Proportion of eligible studies obtaining all NHS Permissions within 40 calendar days (from receipt of a valid complete application by NIHR CRN)

80% n/a Production of weekly report from local ‘Study Management System’ database for CRN NENC CI-led studies to ensure that 15 day performance indicator target is on track. Performance reviewed by NENC Study Support Team. In conjunction, production of weekly report regarding local PO performance to grant NHS permission to assess for potential delays or blocks and utilising this information, the Research Operations Manager to liaise with PO R&D managers regarding any local processes that may be affecting the timely permission process

Weekly review

All PO R&D managers to review local SOP re granting NHS permission to reflect forthcoming HRA approval. Interim office processes or addendums to existing office processes or SOPs will be introduced with the intention of introducing a collaborative SOP across NENC

Monthly feedback reports

Utilising the above 2 actions we would strive to maintain the target of 80% by year end Monthly review 5 Reduce the time taken to

recruit first participant into NIHR CRN Portfolio studies

A: Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites

80% 80% Monitor Site opening/ Site Initiation date and first consent date of research studies on a local study basis. Collate local intelligence on adherence to recruitment within 30 days of opening and support local teams to achieve this within the first month of opening studies.

Monthly feedback minimum from

site teams Share any dates with national industry team via RAG study update notes process or on an ad hoc basis

with industry national Co-ordinating Centre.

Monthly

Highlight any First European or First Global patients as soon as in receipt of this information As received B: Proportion of non-commercial studies achieving first

participant recruited within 30 calendar days of NHS Permission being issued

80% 80%  Monthly production of dashboard LCRN report (RAG rated) and utilising this information, the Research Operations Manager to liaise with PO R&D managers regarding any local processes that may be affecting effective first patient recruited.

 Develop clear lines of responsibilities through close collaborative working with Newcastle University Clinical Trials Unit to identify and resolve issues relating to ‘Red’ rated studies

Monthly reports

Monthly exception reporting from PO R&D managers to Research Operations Manager to include reasons for not achieving 30 day recruitment target (this would be the same choice of reasons as for the NHS 70 day benchmark)

Monthly feedback returns

Utilising the information gained from the above 2 interventions, work with local teams to support the achievement of this target of 80% by year end

Monthly

6 Increase NHS participation in NIHR CRN Portfolio Studies

A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies

99% 99% All of our POs are research active and have reported activity in each quarter in 2014-15, therefore this is business as usual supported through RDMs and CRSLs

Ongoing

B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies

70% 70% Monitor proportion using data from RAG reports and ODP to ensure that PO coverage remains greater than 70% (currently at 100%)

Quarterly

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Objective Measure CRN Target

LCRN Goal

Specific key local activities for 2015-16 Timescale

 Industry team to work consistently across all POs to ensure that commercial research activity is promoted in all POs

 Flag significant risk areas for reduction of commercial activity at PO level. Discussed between Industry Operations Manager (IOM) and Industry Manager as part of their monthly RAG feedback sessions and escalate as necessary

Monthly

C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies

25% 25% 46% of our General Medical Practices (GMPs) have recruited in 2014-15 (as at 20/02/15), and all 13 of our CCGs have more than one active practice, therefore to some extent this will continue to be business as usual. However this is not a consistent spread across all 13 CCGs (26-80% GMPs active), and recruitment in active practices ranges from 1 (a large number of Practices ~80 have only recruited a single participant) to 258. The Research Site Initiative scheme is being redesigned and replaced with the Research Delivery Programme locally to provide more appropriate support to GMPs and be more responsive to those practices with the greatest potential for consistent delivery. We will continue to actively monitor performance in this new scheme

Ongoing

Through the (already identified) CCG research leads/champions we will identify min. 1 GP to be mapped to each Clinical Research Specialty Group, to act as the information conduit/link across Primary care to facilitate GMPs recruiting to studies across all Specialties

End Q1

7 Increase the number of participants recruited into Dementias and

Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio

Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio

13,500 1,200  Promote and maximise use of Join Dementia Research (JDR) to identify participants for DeNDRoN studies

 Explore possibility of Continuous Improvement project across POs to enable easier access and cross-working to access records in response to JDR participants being identified as possible recruits to DeNDRoN portfolio studies

 Link into LCRN PPI and Comms cross-cutting teams to promote JDR across the network at all opportunities throughout the year

Ongoing

 Work closely with named Research Leads to support feasibility, ensure a rich and balanced portfolio and region-wide engagement with POs and clinical teams to prioritise dementia research  Working at a pre-application/pre-approval stage with local Chief Investigators to promote the use

of JDR and assist with wording for ethics submission.

 Ensure new studies are uploaded into JDR and search criteria are set to maximise effective recruitment.

 Promotion of JDR as a feasibility tool to CIs to gather intelligence on dementia populations providing more accurate feasibility

 To link into JDR at a national level to maximise recruitment opportunities for our region

 Enable Team Leaders to provide professional leadership to DeNDRoN delivery staff by ensuring time available to do this and to link into national Senior Leader groups.

 By ensuring sufficient resource is available to increase access to dementia research for people living in care homes the LCRN will aim to increase research capacity and increase its contribution to HLO7

Explore the possibility of a pilot scheme in Northumbria to establish Nursing Home Matrons as ENRICH champions. This will be timed to complement a locally led study in this geographical area and will be hand in hand in enrolling the care homes into the ENRICH programme.

Ongoing

 Capitalise on the Government’s priority for dementia by working into cross-cutting themes of PPI and communications to promote dementia research throughout the LCRN geography at all opportunities and via the LCRN newsletter and website www.makingresearchbetter as well as www.patientsinresearch.org.

Maximise use of feasibility tools as a possible mechanism of identifying patients in primary care who would be eligible for DeNDRoN portfolio studies

Ongoing

The proposed local goals for HLO7 have been informed by our local recruitment goals for the Dementias and neurodegeneration specialty.

 DeNDRoN CRSL and Team Leader reviewed local intelligence of the Portfolio of open and pipeline studies and this informed estimated recruitment goals

 Network divisional leadership team consulted POs and gathered intelligence on their estimated recruitment goals for the DeNDRoN specialty

 RDM reviewed all information with CRSL and agreed a local goal of 1200 which is also an appropriate share of the national target of 13,500 participants into the DeNDRoN Portfolio

CRN: [North East and North Cumbria] Annual Plan 2015-16

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Table 2. LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty Objectives 2015-16

GROUP 1: INCREASING THE BREADTH OF RESEARCH ENGAGEMENT IN THE NHS

Increasing the opportunities for patients to participate in NIHR CRN Portfolio studies

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s)

1.1 Cancer Increase the opportunities for cancer patients to take part in research studies, regardless of where they live, as reflected in National Cancer Patient Experience Survey responses

Number of LCRNs which have an action plan to increase access in each subSpecialty (eg by opening studies, increasing awareness and forming referral pathways for access to research)

15  A local Network strategy for Cancer was written in 2014 which identify priorities over three years. The Clinical Research Lead (CRL), Research Delivery Manager (RDM) and Clinical Research Specialty Leads (CRSLs) will develop an action plan to take these priorities forward eg to increase the number of studies for lung cancer  Having appointed subspecialty Leads we will formalise contact with

them (see 3.1)

 To work with those successful in receiving network support through the ‘Greenshoots’ scheme (small awards made to emerging researchers, not previously in receipt of Network funding with the aim of developing them to become PIs). This will expand cancer activity in Northumbria Healthcare NHS FT (NHCT), neuroradiology, urology surgery and early phase studies

 The CRL/CRSL and RDM attend Network Site Specific Group (NSSG) meetings to discuss research. A research bulletin and list trials will be provided to NSSGs and multi-disciplinary teams (MDTs)

 Progress towards identified actions in the plan will be reviewed by the leadership team on a quarterly basis

1.2 Children All relevant sites that provide services to children are involved in research

Proportion of NHS Trusts recruiting into Children’s studies on the NIHR CRN portfolio

95% Via our local Clinical Research Specialty Group (CRSG) the following actions will be taken during 2015-16 to ensure all relevant sites that provide services to children are research active:

 Currently some smaller acute NHS Trusts have no activity linked to the Children’s Specialty. We have identified a number of Clinicians within many of these Partner Organisations (POs) who we will engage with, in conjunction with Trust R&D teams, to ensure appropriate studies are identified and setup

 We will identify flexible resource to support activity where there is limited access to research delivery staff

 A consistent process for managing Expressions of Interest (EOIs) within the Network has now been established for non-commercial studies. This will ensure equity of access and support is available to appropriate studies

 There are a number of other POs, such as the Mental Health Trusts and Primary Care, which provide children’s services and already recruit children into Portfolio studies. However, this activity is reported under a different specialty and we will work with these POs to acknowledge and support this activity at a local level. We will also identify Children’s Specialty Portfolio studies which could be delivered within these organisations

 Identify activity attributed to other clinical specialties which involve children (e.g. diabetes, genetics, neurology) and ensure that this acknowledged at a local level

 Support Chief Investigators from within local POs and where possible ensure local collaborations are established to maximise the potential recruitment within the Network.

1.3 Critical Care Increase intensive care units’ participation in NIHR CRN Portfolio studies

Proportion of intensive care units recruiting into studies on the NIHR CRN Portfolio

80%  In 2014-15 all acute Trusts recruited into a critical care study and we would expect this to continue in 2015-16

 By their nature some studies are not suitable for smaller units but we will continue to ensure all acute trusts have the opportunity to express interest and work with POs to ensure capacity and resource to support 1.4 Dermatology Increase NHS participation in Dermatology studies on the

NIHR CRN Portfolio

Number of sites recruiting into Dermatology studies 150



Recruitment from 7 (of 9) acute Trusts within the Network is targeted through ‘hub and spoke’ model with hubs at Newcastle upon Tyne Hospitals NHS FT (NuTH), County Durham and Darlington NHS FT

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) (CDDFT) and South Tees Hospitals NHS FT (STees). In addition, recruitment from minimum of one AQP/GP Practice per CCG (13)  Opportunities to develop research activity within Cumbria supported

through cross-specialty network nurse resource is being explored. Additional support via increased in consultant sessional support in North Cumbria University Hospitals (NCUH) will also be explored  A Dermatology Research Nurses forum is being supported for sharing

of good practice and opportunity as well as attention to patient burden on groups of studies often introduced together.

1.5 Ear, Nose and Throat (ENT)

Increase NHS participation in Ear, Nose and Throat studies on the NIHR CRN Portfolio

Proportion of acute NHS Trusts recruiting into ENT studies on the NIHR CRN Portfolio

40%  In 2014-15, 4 of 5 Trusts providing ENT services in the Network recruited to ENT studies

 The 5th Trust has made a recent appoint of a new Consultant with a keen interest in ENT research, therefore we envisage that all acute Trusts providing ENT services will be able to recruit

1.6 Gastroenterology Increase NHS participation in Gastroenterology studies on the NIHR CRN Portfolio

Proportion of acute NHS Trusts recruiting into Gastroenterology studies on the NIHR CRN Portfolio

90%  In 2014-15 all acute Trusts recruited into a Gastroenterology study  Each Trust has a nominated Gastroenterology lead with an agreed local

action plan for 2015-16

 We areworking with low recruiting POs to support existing PI's and one PO has accessed support from another

 We will continue to support cross-working as capacity demands - our newly established Nursing group within the CRSG will also support less experienced nurses and provide support and advice to the newer teams 1.7 Haematology Increase NHS participation in Haematology studies on the

NIHR CRN Portfolio

Proportion of eligible NHS Trusts undertaking Haematology studies in each LCRN

50% We are already achieving this target within NHS Trusts which provide

haematology services but will continue to work towards engaging more sites in haematology research in anticipation of a more challenging goal next year 1.8 Injuries and

Emergencies

Increase NHS major trauma centres’ participation in NIHR CRN Portfolio studies

Proportion of NHS major trauma centres recruiting into NIHR CRN Portfolio studies

100%  Our two major Trauma centres (NuTH and STees) both recruit into I&E studies

 Both centres have good links with the North East Ambulance Service (NEAS) and we keen to work with all 3 institutions to further develop their respective portfolios

1.9 Injuries and Emergencies

Increase NHS emergency departments’ participation in NIHR CRN Portfolio studies

Proportion of NHS emergency departments recruiting into NIHR CRN Portfolio studies

30%  In 2014/15 all emergency departments within our Trusts recruited into NIHR CRN Portfolio studies and we expect to maintain that level in 2015-16

 A new large emergency centre is due to open in NHCT and we are hoping to develop a research portfolio there

 We will continue to ensure all Trusts with an emergency department have an opportunity to express interest and work with PO’s to ensure capacity and resource to support

1.10 Musculoskeletal Increase NHS participation in Musculoskeletal studies on the NIHR CRN Portfolio

Number of sites recruiting into Musculoskeletal studies on the NIHR CRN Portfolio

300  Recruitment will be targeted in all 9 acute NHS Trusts and at least one General Medical practice per CCG (13)

 Primary care recruitment is being promoted and driven by securing specialist interest GP and community physiotherapist representation on to the CRSG

 Plan to include developing activity NCUH with selected ‘entry-level’ studies and also for North Tees and Hartlepool NHS FT (NTH) and STees collaborative musculoskeletal research delivery to be supported  A Rheumatology co-lead has been appointed to work with MSK CRSL

to engage all regional consultants in the Group and spread the opportunity of NuTH led studies region-wide where feasible 1.11 Ophthalmology Increase NHS participation in Ophthalmology studies on

the NIHR CRN Portfolio

Proportion of acute NHS Trusts recruiting into Ophthalmology studies on the NIHR CRN Portfolio

60%  In 2014-15 all 5 of our Trusts providing Ophthalmology services recruited to Portfolio studies

 We will continue to ensure that all of these POs have an opportunity to express interest and work with them to ensure appropriate capacity and resource are available

 We are also keen to work with Optometrists in Primary care and will explore this as an area for expansion in 2015-16

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) We hope to establish an Ophthalmology Trainee network similar to Intensive Care and Anaesthesia Audit and Research Network North East Trainees (INCARNNET)

 INCARNNET (Anaesthesia)

 At Sunderland Eye Infirmary (part of City Hospitals Sunderland NHS FT), trainee participation is actively encourage with 4 out of 6 trainees currently actively participating in study recruitment

 Participation of trainee doctors in these clinical trials has not only improved their understanding of ethical research but promoted development of essential skills for best medical practice and ignited their enthusiasm for future research

 As a network we are keen to emulate this trainee involvement in all of our active Trusts

1.12 Renal Disorders Increase the proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which actively engage renal and urological patients in research

Proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which implement Patient Carer & Public Involvement and Engagement (PCPIE) strategies for Renal Disorders research

25%  The renal research group at NuTH produces regular newsletters for patients. These will continue to be developed in collaboration with Tyneside Kidney Patients Association who, in the future, will circulate the newsletters with their regular bulletins

 In 2015-16 this will be supported by the CRN Communications Team to develop this further so other contributing renal units benefit

 Tyneside Kidney Patients Association will be invited to attend SG meetings

The CRSL lead is co-lead on the national Specialty Group for communication and has been involved in the development of the Renal Disorders website. 1.13 Stroke Increase the proportion of NHS Trusts, providing acute

Stroke care, recruiting to Stroke studies on the NIHR CRN Portfolio

Proportion of NHS Trusts, providing acute Stroke care, recruiting participants into Stroke studies on the NIHR CRN Portfolio

80% All Trusts providing acute care are recruiting into NIHR CRN Stroke studies and we expect to maintain this activity in 2015-16

1.14 Surgery

Increase NHS participation in Surgery studies on the NIHR CRN Portfolio

Proportion of acute NHS Trusts recruiting patients into Surgery studies on the NIHR CRN Portfolio

85%  In 2014-15, 8 of our 9 acute Trusts recruited to Surgery studies. The one remaining Trust has recruited well to a study jointly supported by Surgery

 In 2015-16 we expect all acute Trusts to recruit to a surgery study  We will continue to ensure all trusts have an opportunity to express

interest and work with PO’s to ensure appropriate capacity and resource are available

GROUP 2: PORTFOLIO BALANCE

Delivering a balanced portfolio (across and within Specialties) that meets the needs of the local population and takes into account national Specialty priorities

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s)

2.1 Ageing Increase access for patients to Ageing studies on the NIHR CRN Portfolio

Proportion of Ageing-led studies which are multicentre studies

50%  This target has already been exceeded locally, with 4 multi-centre studies open within the Network

 2 new multicentre studies led or co-led from the Network will open in the coming year:

1. Health Services and Delivery research funded ‘Acute Hospital Care for Older People.’

2. EME funded LACE trial, ACE inhibitor and leucine in sarcopenia For other recently funded Ageing trials, NENC has been identified as a site including:

3. BICARB Trial (renal) – a multicentre trial to be opened in NENC, led by Ageing

 Many more studies are supported by Ageing and through engagement with ENRICH programme, it is envisaged that this number will increase  GP membership on the CRSG is also designed to enable rapid

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 2.2 Cancer Increase the number of cancer patients participating in

studies, to support the national target of 20% cancer incidence

Number of LCRNs recruiting at or above the national target of 20%, or with an increase compared with 2014-15

15  Implementation of sub Specialty Lead action plan within each tumour area to increase recruitment to open trials

 Active portfolio management to highlight poor recruitment and engage with PIs

 Explore opportunities with PIs and local CIs for development of locally-led portfolio studies

 Regular information updates to site specific MDTs, Strategic Clinical Networks and NSSGs about open studies to ensure network wide recruitment.

2.3 Cancer Increase the number of cancer patients participating in interventional trials, to support the national target of 7.5% cancer incidence

Number of LCRNs recruiting at or above the national target of 7.5%, or with an increase compared with 2014-15

15  Implementation of sub Specialty Lead action plan within each tumour area to increase recruitment to open trials

 Active portfolio management to highlight poor recruitment and engage with PIs

 Regular information updates to site specific MDTs, CNSs and NSSGs about open studies to ensure network wide recruitment.

2.4 Cancer Deliver a Portfolio of studies including challenging trials in support of national priorities

Number of LCRNs recruiting into studies in:  Cancer Surgery

 Radiotherapy

 Rare cancers (cancers with incidence <6/100,000/year)

 Children's Cancer & Leukaemia and Teenagers & Young Adults

15  We intend to maintain our current broad portfolio, which already includes Cancer Surgery studies, and ensure active recruitment in each area through contact with PIs. In particular;

Radiotherapy - CRSL has been appointed for radiotherapy research within the Network. Each site has a radiotherapy lead that will be responsible for a portfolio of studies at their site, promotion of research at MDTs and supporting registrar involvement (identification of registrar champions for radiotherapy trials with the aim of improving recruitment). Children’s Cancer & Leukaemia – a ‘Northern Network’ is establishing for children and young people with Cancer which will serve the North East and Cumbria, Scotland and North Ireland. This will offer a network approach to trials opening within this geography. By covering a larger population it will be feasible to open studies for patients with rare cancers. The aim will be to double the number of early phase studies across the spectrum of disease areas.

Teenagers & Young Adults (TYA) – working with the TYA Lead, MDTs, NSSGs and Children and Young People Co-ordinating Group to develop and implement strategies to improve recruitment of patients within this age group

2.5 Cardiovascular Disease

Increase access for patients to Cardiovascular Disease studies on the NIHR CRN Portfolio

Number of LCRNs recruiting into multi-centre studies in at least five of the six Cardiovascular Disease subSpecialties

15  The Network already contributes to studies across all of the sub-Specialties in 10 of the 14 POs in the geography (only the 3 Mental H Health and Ambulance Trusts have not recruited to these studies)  We have appointed a senior nurse (theme) lead with responsibility for

overseeing the delivery of multicentre studies across the CRN. The combination of this appointment and the fact that the delivery workforce has been maintained means that the expectation is that all POs will recruit in 2015-16 and this target will be met

2.6 Diabetes Increase support for areas of Diabetes research where traditionally it has been difficult to recruit

Number of LCRNs recruiting into diabetic foot studies on the NIHR CRN Portfolio

15 There are currently 3 sites recruiting into diabetic foot studies in the Network and we are looking to expand involvement to at least one other PO

2.7 Diabetes Increase access for people with Type 1 Diabetes to participate in Diabetes studies on the NIHR CRN Portfolio early after their diagnosis

Number of LCRNs approaching people with Type 1 Diabetes to participate in interventional Diabetes studies on the NIHR CRN Portfolio within six months of their diagnosis

15  The CRN has an existing designated nurse supporting ADDRESS 2 that recruits newly diagnosed T1 diabetic patients into a registry for future studies

 In the last 12 months 20 patients have been recruited into ADDRESS 2 - we will continue to support this study as it is the main tool for

identifying patients diagnosed with T1DM and approaching them for other interventional trials within the 6 month window.

2.8 Gastroenterology Increase the proportion of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio

Number of participants (per 100,000 population), recruited into Gastroenterology studies on the NIHR CRN Portfolio

15  In 2015-16, we are confident that we will increase the number of participants recruited into Gastroenterology Studies from our current level of 10 per 100,000

 Each acute Trust has a nominated Gastroenterology lead with an agreed local action plans for 2015-16

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s)  A locally-led study ‘Adenoma’ recently opened across a number of sites

in our Network, which is expected to yield large recruitment numbers  The CRSG are leading on an Industry GI Collaborative which will

enable us to pool patient resource across the network, enabling all patients the opportunity of accessing commercial studies as well as the more complex early phase 1&2 studies run within the network

2.9 Genetics Increase access for patients with rare diseases to

participate in Genetics studies on the NIHR CRN Portfolio

Number of LCRNs recruiting into multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium

14 We already recruit to multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium and this will continue throughout 2015-16

2.10 Haematology Increase access for patients to Haematology studies undertaken by each LCRN

Number of LCRNs recruiting into studies in at least three of the four following Haematology subSpecialties :

Haemoglobinopathy, Thrombosis, Bleeding disorders, Transfusion

15  We currently recruit to thrombosis and bleeding disorders studies within the Network

 Due to the low prevalence of haemoglobinopathies (e.g. sickle cell disease, thalassaemia) within the demographic of our catchment population it is unlikely that a study in this clinical area would be feasible

 We will therefore focus on maximising engagement with Portfolio studies in transfusion- at least one such study is due to open in NUTH during 2015

2.11 Hepatology Increase access for patients to Hepatology studies on the NIHR CRN Portfolio

Number of LCRNs recruiting into a multi-centre study in all of the major Hepatology disease areas (including Viral Hepatitis, NAFLD, Autoimmune Liver Disease, Metabolic Liver Disease)

15  In 2014-15, 7 of our 9 acute Trusts in the Network recruited to Hepatology studies and we are recruiting to studies in all major Hepatology disease areas

 We are working closely with all our acute Trusts and have agreed leads in each Trust keen to take forward and develop their own local

portfolios

 We will continue to ensure all acute Trusts have an opportunity to express interest and work with PO’s to ensure appropriate capacity and resource are available

2.12 Infectious Diseases and Microbiology

Increase access for patients to Infectious Diseases and Microbiology studies on the NIHR CRN Portfolio

Number of LCRNs recruiting into antimicrobial resistance research studies on the NIHR CRN Portfolio

15  In 2014-15, 5 of our 9 acute Trusts recruited to Infectious Diseases (ID) and Microbiology studies

 The 3 main ID centres (NuTH, NHCT, STees) are now collaborating as a group to review and ensure as a region we are coordinating relevant trials

 We will work with all Trusts for microbiology studies to ensure they have the opportunity to express interest and that there is appropriate capacity and resource

 In 2015-16 we also plan to develop the Genital Urinary medicine (GUM) ID portfolio and will work with interested PIs‘s within Trusts and across primary care to do this

2.13 Metabolic and Endocrine Disorders

Increase access for patients with rare diseases to participate in Metabolic and Endocrine Disorders studies on the NIHR CRN Portfolio

Number of LCRNs recruiting into established studies of rare diseases in Metabolic and Endocrine Disorders on the NIHR CRN Portfolio

15  Through regional meetings, e-mails and personal contact from CRSL we continue to interact with endocrinologists across the Network so they are aware of research activities in rare diseases

 Ensure local PIs have support in obtaining approvals by increasing access to CRN Study Support team

 In 2015-16 our local target is to increase the number of POs recruiting to M & E studies

2.14 Oral and Dental Increase access for patients and practitioners to Oral and Dental studies on the NIHR CRN Portfolio

A: Proportion of Oral and Dental studies on the NIHR CRN Portfolio recruiting from a primary care setting

20%  Primary Care Dental Research Forum CPD event for GDPs across the region is planned for June 2015 and an appropriately tailored form of Research Site Initiative (RSI) scheme to be introduced for community dentists

 Pipeline of community based research for dental is currently not evident however with 2 large studies recently complete

B Proportion of participants recruited from a primary care setting into Oral and Dental studies on the NIHR CRN Portfolio

30%  Subject to available pipeline, a role of dental facilitator will be explored with focus on Primary Care

 CRSG is exploring the use of NIHR publicity with associated HEI partnerships being used within community settings.

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 2.15 Primary care Increase access for patients to NIHR CRN Portfolio studies

in a primary care setting

Proportion of NIHR CRN Portfolio studies delivered in primary care settings

15%  Implementation of feasibility tools across the Network to increase access to primary care populations for all CRSGs

 Re-design of the RSI scheme to ensure that resource follows activity and opens up all potential primary care sites including e.g. pharmacy  Increase the proportion of GPs as members of CRSGs, aiming for full

coverage of all Specialties

 Commissioning Support Unit delivery staff also supported to join Specialty Groups across the Divisions

2.16 Renal Disorders Increase NHS participation in Renal Disorders studies on the NIHR CRN Portfolio

A. Proportion of acute NHS Trusts recruiting into multi-centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio

30%  Currently there are 9 RCTs open and recruiting across 5 of our 9 acute Trusts within the Network and therefore we have exceeded (and expect to maintain) this target

 There is a move locally to expand the Benign Urology portfolio and we envisage that this will open up new opportunities for other POs to contribute

 The commercial pipeline is healthy and the target is to open up at least one further PO to commercial recruitment during 2015-16.

B. Proportion of Renal Units recruiting into multi-centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio

80%  100% of Renal Units within our Network (4 of 4) are recruiting into m/c RCTs, our expectation is that this will continue

2.17 Respiratory Disorders

Increase access for patients to Respiratory Disorders studies on the NIHR CRN Portfolio

Number of LCRNs recruiting participants into NIHR CRN Portfolio studies in the Respiratory Disorders main disease areas of Asthma, COPD or Bronchiectasis

15  In 2014-15, 7 of our 9 acute Trusts in the network recruited to Respiratory studies.

 We are working with all our Trusts and Primary Care to identify local leads keen to take forward and develop local portfolios inclusive of Asthma, COPD and Bronchiectasis

 We feel there is significant potential to further develop the Network’s Respiratory Portfolio and will continue to ensure all Trusts have an opportunity to express interest and work with PO’s to ensure appropriate capacity and resource are available to support 2.18 Stroke Increase the proportion of patients recruited into Stroke

randomised controlled trials on the NIHR CRN Portfolio

Number of patients (per 100,000 population) recruited into Stroke randomised controlled trials on the NIHR CRN Portfolio

8 This level is already exceeded, with the Network currently recruiting 20 patients per 100,000

2.19 Stroke Increase activity in NIHR CRN Hyperacute Stroke Research Centres (HSRCs)

A: Number of patients recruited to Hyperacute Stroke studies on the NIHR CRN Portfolio in each NIHR CRN HSRC

50 Review of the patient pathways leading to rapid transfer within the region

B: Number of patients recruited to complex Hyperacute Stroke studies on the NIHR CRN Portfolio in each NIHR CRN HSRC

15 Reconfiguration of the research support infrastructure and MRI availability at the Royal Victoria Infirmary (Newcastle upon Tyne Hospitals NHS FT) as host for the HSRC

GROUP 3: RESEARCH INFRASTRUCTURE

Developing research infrastructure (including staff capacity) in the NHS to support clinical research

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s)

3.1 Cancer Establish local clinical leadership and a defined portfolio across the cancer subSpecialty areas

Number of LCRNs with, for each of the 13 Cancer subSpecialties, a named lead and a defined portfolio of available studies

15

Sub-Specialty Leads have been identified and the leadership team will maintain regular contact with sub-Specialty Leads with two monthly updates from each including feedback from national meetings

3.2 Anaesthesia, Perioperative

Establish links with the Royal College of Anaesthetists’ Specialist Registrar networks to support recruitment into

Number of LCRNs where Specialist Registrar networks are recruiting into NIHR CRN Portfolio studies

4  We are actively engaged with the trainee network

 Dr Ed Pugh is chair of the local trainee network (INCARNNET) and is a member of our CRSG

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) Medicine and Pain

Management

NIHR CRN Portfolio studies  Dr Mark Callaghan appointed as in-programme research fellow for 6

months in February 2015 and will have 1 day per week to develop INCARNET; he will also be leading on POPULAR an observational portfolio study

 We are encouraging the trainee network to apply for a small research grant in Spring 2015 supported by consultant members of the CRSG 3.3 Dementias and

Neurodegeneration (DeNDRoN)

Optimise the use of “Join Dementia Research” to support recruitment into DeNDRoN studies on the NIHR CRN Portfolio

The proportion of people identified for DeNDRoN studies on the NIHR CRN Portfolio via “Join Dementia Research”

3%  Maintain delivery staff training (currently >70% trained) & support to enable access and use of JDR.

 Continue links & promotion of JDR through memory clinic research champions

 Continue to support our JDR Champion in promoting public awareness of JDR

 Ongoing promotion to clinical teams in POs to raise awareness of JDR  Ongoing involvement in national monthly teleconferences

 Ensuring use of JDR where appropriate in all recruitment strategies  Promote JDR ‘success stories’ in LCRN newsletter

 Link to JDR on Network supported PPIE website: www.makingresearchbetter.co.uk

3.4 Dementias and Neurodegeneration (DeNDRoN)

Increase the global and psychometric rating skills and capacity of LCRN staff supporting DeNDRoN studies on the NIHR CRN Portfolio

Proportion of LCRN staff who support DeNDRoN studies who have successfully completed Rater Programme Induction and joined the national Rater database

40%  50% of staff who support DeNDRoN studies have completed the Rater Programme Induction and have joined the national Rater database  These levels will be monitored to ensure ongoing compliance with this

measure by ensuring new staff have access to training and that all staff have access to Rating opportunities where possible, to maintain skills  Resource has been included In the Network’s Learning and

Development programme to fund attendance at a ‘Train the Trainer’ session should this become available nationally. The Network will then add the Rater Programme Induction to the Learning and Development programme locally

3.5 Infectious Diseases and Microbiology

Maintain research preparedness to respond to an urgent public health outbreak

Number of LCRNs maintaining a named Public Health Champion

15 Dr David Chadwick – [email protected]

 The Network has developed and actively promoted an Urgent Health Care Research Delivery Plan

 To ensure business continuity processes are maintained we will work with POs to ensure essential business processes can be maintained including covering major staff absence, and prioritisation of business activities

 The NHS Permissions process for expediting ‘sleeping studies’ is now established and local R&D departments are aware of their role in expediting this, and we are confident they will be able to respond quickly and initiate and report on studies related to the pandemic /outbreak, including EBOLA studies (NB NuTH is a designated EBOLA treatment centre)

 A network working group has been convened to meet in the case of an urgent public health outbreak. This group will also review the plan and list of studies on an annual basis. The group includes representation from Public Health England

3.6 Mental Health Maintain and enhance the skills and capacity of staff supporting Mental Health studies on the NIHR CRN Portfolio in frequently used Mental Health study eligibility assessments (e.g. PANSS, MADRS, MCCB)

Number of staff trained in frequently used Mental Health study eligibility assessments

139

 9 out of 14 staff members supporting MH studies are trained and have used PANSS eligibility assessments.

 Staff members supporting MH studies have had training and opportunity to use other frequently used MH study eligibility assessments eg AIMS, CGI-S, EQ-5D, ASCQ, CDSS

 Ian MacMillan, Consultant Psychiatrist and local PI has been identified as a trainer for the national CRN: Mental Health PANSS Training program.

 We will identify a local training facilitator to participate in the Train the Trainer programme and deliver PANSS training locally thereafter.  We will monitor staff skills and capacity to maintain and enhance

ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 3.7 Neurological

Disorders

Increase clinical leadership capacity and engagement in each of the main disease areas in the Neurological Disorders (MS; Epilepsy and Infections) Specialty

Number of LCRNs with named local clinical leads in MS; Epilepsy and Infections

15  MS Lead – Dr Joe Guadagno

 Epilepsy Lead } We do not yet have identified leads for these areas  Infections Lead} and will work to identify them in year

3.8 Reproductive Health and Childbirth

Increase engagement and awareness of the Reproductive Health and Childbirth Specialty

Number of LCRNs with a named midwifery lead to increase engagement and awareness

15  Network Midwife Champion appointed – Fiona Yelnoorkar, and attendance at national meetings will continue to be supported

 Process underway to identify RH&C Nurse Champion to work with the Midwife Champion to ensure awareness and engagement across the entire RH&C portfolio

 Local Nurse/Midwife research forum held quarterly to aid engagement, sharing best practice and personal and professional development.

CRN: [North East and North Cumbria] Annual Plan 2015-16

15

Table 3. LCRN plans against the Operating Framework 2015-16

POF Area Operating Framework requirement Operating

Framework Reference

Information required Planned LCRN actions/activities for 2015-16 or other

requested information

Milestones & outcomes once complete

Timescale

LCRN Governance The Host organisation shall develop and maintain an assurance

framework including a risk management system

3.12 Assurance that a framework and system are in place to be provided by the Host organisation nominated Executive Director’s signature on Annual Plan coversheet and submission of a copy of the latest version of the LCRN’s risk register as Appendix 1 to the Annual Plan

N/A N/A N/A

The Host organisation will ensure that robust and tested local business continuity arrangements are in place for the LCRN. This is to enable the Host organisation to respond to a disruptive incident, including a public health outbreak, e.g. pandemic or other related event, maintain the delivery of critical activities / services and to return to ‘business as usual’. Business continuity arrangements should be in line with guidance set out by the national CRN

Coordinating Centre.

3.14 Assurance that robust and tested local business continuity arrangements are in place for the LCRN to be provided by the Host organisation nominated

Executive Director’s signature on Annual Plan coversheet

N/A N/A N/A

The Host organisation must ensure that appropriate arrangements are in place to support the rapid delivery of urgent public health research, which may be in a pandemic or related situation. It shall ensure that the LCRN has an Urgent Public Health Research Plan which can be immediately activated in the event that the Department of Health requests expedited urgent public health research. The Host must also appoint an active clinical investigator as the LCRN’s Public Health

Champion to act as the key link between the LCRN and the national CRN Coordinating Centre and support the Urgent Public Health Research Plan in the event of it being activated.

3.15 Assurance that the LCRN has an Urgent Public Health Research Plan in place to be provided by the Host organisation nominated Executive Director’s signature on Annual Plan coversheet

Existing plan to be activated upon request As per plan Not known

Confirm name and contact details of LCRN’s Public Health Champion against Specialty objective 3.5

Provided via completion of Table 2 N/A N/A

The Host organisation must ensure that LCRN activity is included in the local internal audit programme of work

3.17 Date of planned audit or anticipated timescale if exact date not yet known

Scheduled for Q3

2014-15 audit report received 23 December 2014. Management response provided March 2015.

N/A Q3

Research Delivery The Host organisation shall ensure that all LCRN organisations adhere to

national systems, Standard

Operating Procedures and operating manuals in respect of research delivery as specified by the national CRN Coordinating Centre. The Host organisation shall ensure that the

6.1-6.20 Provide confirmation that the LCRN has a link person for the CRN Study Support Service programme and describe how information is cascaded to relevant colleagues

Sharon Dorgan, Research Operations Manager is the assigned link person for the LCRN and is a member of the national Study Support Service links working group and has already participated in the first national meeting.

Information on the service has been cascaded through a variety of routes: to R&D managers via regional LCRN chaired research meetings, to the LCRN Operational

Management Group, to the LCRN Executive and information will be shared with the wider research community via a

Link person in place

Meeting dates & venues have been set and details circulated for 2015

01/12/2014

LCRN management team provides excellent study performance management, in line with the standards and guidance issued by the national CRN Coordinating Centre, in order to ensure that all NIHR CRN Portfolio studies recruit to agreed timelines and targets.

poster presentation at a NENC network event to be held in February 2015.

Provide a brief outline (1-2 paragraphs) of the LCRN’s plans for implementation and delivery of the Study Support Service

A rebranding exercise, to incorporate the terminology of ‘Study Support Service’ has already taken place within the LCRN. This term is now used to describe the personnel that were formally known as the core ‘RM&G’ team, alongside those of the Research Study Coordinating team.

This amalgamated team now has established weekly teleconference meetings and monthly face to face meetings to review progress of studies along the research pathway. The central email inboxes of the former 2 teams have also been amalgamated into one and comprise the term ‘study support’ within the email address.

The next plan for the service is to include a review of new potential models of working whilst remaining a cross-cutting theme. A survey to assess NENC chief investigators support requirements is also being prepared as well as piloting the benefits of a Chief Investigator support champion across the LCRN.

On-going management & development

Central point of contact established for the service

Clear indication of support requirements so that the service can be tailored accordingly 01/01/2015 on-going 01/01/2015 Survey to be circulated 02/15. Review of CI service July 2015

Provide a summary of expertise and skills that you have available locally to support implementation of AcoRD including the number of individuals able to provide advice on the attribution of activities in line with the Attributing the costs of health and social care Research & Development (AcoRD) guidance1 and a description of the model(s) the LCRN has used to date in providing advice

CRN NENC has an AcoRD Specialist and training to support implementation of AcoRD was initially offered to R&D managers back in 2014. The RDS, AcoRD Specialist, R&D Managers and their finance teams in all POs can be contacted for advice on the attribution of activities. This model will continue alongside the local development of the study support service

Effective and responsive service available to Chief Investigators wherever they intersect with the LCRN

Ongoing

Provide a brief outline of local plans for supporting CSP BAU activities within local delivery structures in accordance with POF, and noting clauses 5.28 & 5.29 when planning RM&G local delivery structures

The LCRN Study Support Team will continue to provide central study wide governance support until this function is transferred across to the HRA during 2015. In the meantime processes are under continuous review to identify any areas for smarter working practices and removal of duplication of effort.

Research Operations Manager to actively engage in planned NIHR workshops regarding HRA readiness plans.

A series of LCRN led teaching sessions regarding the CSP amendments process are being delivered to support local understanding.

Should network funded CSP governance related posts become vacant, the LCRN and POs are in discussion as to how best manage such vacancies and to review appropriate revision of job descriptions to reflect the change in emphasis from governance to delivery moving forward.

On-going management & support

NIHR led workshops and working with other RMG national Leads.

On-going engagement with R&D managers

Monthly review during 2015 to assess progress of HRA plans 02/2015 – 03/2015 Monthly The Host organisation will ensure

that all LCRN Partner organisations adopt NIHR CRN research

management and governance operational procedures.

The Host organisation will ensure that quality, consistency and customer service are central to the LCRN’s purpose in the

implementation, delivery and oversight of NIHR CRN research management and governance services.

The Industry Operations Manager will work closely with the Chief Operating Officer to establish and enable the implementation of the NIHR CRN Industry Strategy within the LCRN. The Industry Operations Manager will establish and lead the

6.21 Provide an outline for the performance management of the provision of local feasibility information (site intelligence and site identification) for commercial contract studies. To include action plans for improvement in performance2.

There is a region wide industry team who are accessed via the single point of contact email and working under the IOM to deliver a robust and consistent feasibility and performance management process throughout the POs and across divisions.

Full cross Divisional and PO coverage in place

01/11/2014

1

Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/351182/AcoRD_Guidance_for_publication_May_2012.pdf

2

cross-divisional Industry function, including the single point of contact service, within the LCRN. The Industry Operations Manager will work closely with each Divisional Research Delivery Manager across all research divisions to ensure consistency of feasibility, study delivery and coordination across all divisions within the LCRN. The Industry Operations Manager will be responsible for the promotion of the Industry agenda to LCRN Partner organisations and investigators, delivering aspects of a national NIHR CRN Industry Strategy within the LCRN.

Feasibility is issued and collated by the industry team in collaboration with the site study teams/ research nurses, potential Principal Investigators (PIs) and Trust R&D Managers or teams. Historical performance information is kept on the industry active PIs and used to populate both site identification and site intelligence. Information is also kept on Trust support systems by the nominated industry team member to complete the forms. Every endeavour is made to adhere to timelines for submission of Site Identification and Site Intelligence and if there are any delays then this is communicated with the CC team to ensure that they are aware of likely late returns and the reasons to communicate to the sponsor.

Local data is monitored not only on successful delivery of time to target and FPFV, but also on trends in EOI outcome (% submitted versus % won by the site) – the intention is that this will show areas of strength and necessary improvement requirements for the industry team to work on.

Recruitment to time and target, and overall industry study performance is monitored via a localised version of the national industry monthly RAG reports, which are

disseminated on a Divisional, Specialty Group and PO basis. These reports include both national data and also local performance data which is amended by POs and fed back to the national industry team via the Industry Study Update Notes on a monthly basis. Amendments include identifying studies missing from the open portfolio, updating dates and targets.

When a study is ‘Red’ for one month or more a local action plan is devised to clarify the nature of the recruitment issue (if there is one) and plan to rectify it. The RAG reports are discussed on a monthly basis on a one-to-one meeting with the IOM by each of the Industry team and escalated where necessary to the region wide industry team meeting for discussion across the team as a whole (where issues are not limited to a single site in the region), escalated to the IOM or Industry Clinical Lead for action, or to the RDM.

Trends and repetitive issues are noted and examined and this information is used to inform the ongoing feasibility process for teams in the future. The local industry team takes part in national teleconferences with Coordinating Centre staff to discuss performance with sponsors/ CROs and feeds back written information/ escalates into the national team where appropriate as well.

Feasibility process pathway developed for Divisions 2, 3, 5 and 6. In progress for

Divisions 4 and 1

LPMS system to enhance this – currently interim Study

Management System in place

Local RAG reports available monthly +2 weeks from National report release or less

Local Escalation plan process in place from 2014 – formalise in writing after evaluation

Strategic analysis of EOI performance and RTT performance – process to be in place and monitored 01/04/2015 01/04/2015 ongoing Monthly April 2015 Review by 31/03/2015 – ongoing monthly thereafter

Provide details of local strategies for achieving LCRN wide usage and adoption by Host and Partner

organisations of the NIHR CRN costing template

Baseline Status

The NIHR CRN costing template is the sole mechanism for negotiating industry costs in all POs across the Network - the process has been wholly adopted by all organisations in this area.

Strategic Development

There is a region-wide, industry team led Finance

Management Group which is continuing to develop strategies for income distribution and management of industry income within the region. This has a membership of representatives of the LCRN Industry team, Continuous Improvement Lead

Complete July 2014 – ongoing management and development

Capacity building spend strategy – agreed by Executive and Partnership Group by 08/01/2015 31/07/2014 Launch 01/04/2015 – yearly return

and Research Management team and also all POs (R&D Manager, R&D Director or Finance Manager).

This group has been working on mechanisms to demonstrate the usage of Capacity Building element of industry costs, and also in development is a region wide joint costing process (using the NIHR costing template) for studies which have more than one site within the NENC region.

Future topics include standard contracts (when the mCTA has been altered but has been legally reviewed and accepted by one or more organisation in the region for a particular sponsor) and invoicing processes.

Region wide costing being developed from 12/02/2015. Informal pilot in place from then onwards. Formal pathway to be agreed Invoice process in development Launch 01/10/2015 Delivering on the Government Research Priority of Dementia

The Host organisation will ensure the LCRN supports this strategy by: Identifying and nominating clinical Research Leads in each of these disease areas (dementias, Parkinson’s disease, Huntington’s disease and motor neurone disease) to support the delivery of the

Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio through local clinical leadership and participation in national activities, including national feasibility review

7.1-7.7 _{Please provide names and contact} details for identified clinical Research Leads for each of these disease areas

Dementias: Dr Andrew Byrne

[email protected] Parkinson’s disease: Dr Richard Walker

[email protected] Huntington’s disease: Dr Suresh Komati

[email protected] Motor neurone disease: Dr Tim Williams

[email protected]

Patient and Public Involvement and Engagement (PPIE)

The Host organisation will support the development and implementation of the NIHR CRN Strategy for PPIE and deliver a workplan with

measurable targets for ensuring that patient choice, equality and diversity, experience, leadership and

involvement are integral to all aspects of LCRN activity, in partnership across NIHR CRN.

8.1-8.6 Provide a comprehensive patient and public involvement and engagement plan in line with agreed format and guidance

Provide via completion of Table 4

The Host organisation must identify a senior leader to take responsibility for Patient and Public Involvement and Engagement (PPIE) within the LCRN. The identified lead will participate in nationally agreed PPIE initiatives and support the delivery of an integrated approach to PPIE across the NIHR CRN.

Provide the name and contact details for the senior leader with identified

responsibility for patient and public involvement and engagement

Hilary Allan – Research Delivery Manager/functional lead for PPIE

[email protected] Chris Elliott – PPI Manager

[email protected]

N/A N/A

Continuous Improvement (CI)

The Host organisation will promote and sustain a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance

9.1-9.6 Provide an assessment of the LCRN’s current position in relation to Continuous Improvement

Continuous improvement (CI) is integral to all that we do in the Network, with significant buy-in across all levels of staff in the central team and transformation being a high priority across the NHS organisations in the North East and North Cumbria. The CI Working Group meets quarterly to discuss CI initiatives and allocate tasks for members to

undertake. The Group is composed of the following members:  CI Lead  Industry representative  RDM  PPI representative  Communications representative

 4 PO representatives (R&D and delivery)

There are two areas of work within CI:

Improving performance and measurement

This looks to identify the appropriate metrics to monitor and show performance towards our objectives, looking for more sensitive measures of performance and local priority measures.

So far, the focus has been on two areas of Network

business: industry and PPIE, looking at incentives to improve commercial funding transparency and recycling and research awareness raising activities within POs. The awareness raising includes badges and cardboard cut outs for use by research staff in POs, and work has started on improved website information, accessible to patients, and research wording on clinic letters.

Culture change and empowerment

This activity utilises Network events to promote CI and start to empower staff at all levels to get involved in improvement projects and creating a CI community, getting suggestions for improvement projects from those at the ‘frontline’ within POs.

This will be backed by training, tapping into the courses already provided by PO ‘lean’/ transformation teams and running NIHR CRN CI training courses. Two members of staff are currently undertaking the Green Belt training provided by the national Coordinating Centre, looking at ways to visualise the workforce from a job role and task viewpoint, working towards resource scenario planning; plus looking at how to embed and widen the use of the NIHR Hub across all the work we do and improve acceptability of it as a tool to share resources.

In February 2015, at the annual Network event ‘Moving from Good to Great’, awards were given out for innovative and collaborative ways of working that have impacted on research delivery in the region. In addition to thanking our research workforce for their dedication, this has enabled us to highlight good practice that we can share across the other specialties and trusts, allowed us to find the innovators who go ‘above and beyond’ to invite into the CI community, and has given us many great stories for use in communications and promotional material. These examples will also be shared nationally through the CI Hub site and with the other CI Leads.

We intend to develop incentivisation mechanisms for POs achieving specific CI targets

Provide an action plan for promoting and sustaining a culture of innovation and continuous improvement across all areas of LCRN activity, including the LCRN’s approach to developing capacity and capability of the LCRN workforce (the latter to be evidenced in the LCRN’s submitted workforce development plan)