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CRN: Thames Valley and South Midlands Annual Plan 2015-16 Val Woods Chief Operating Officer

CRN: Thames Valley and South Midlands Annual Plan 2015-16

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CRN: Thames Valley and South Midlands

Annual Plan 2015-16

Val Woods

Chief Operating Officer

National lnstitute fotHeakh Research

Clini.al Research Networl

NIHR CRN: Thames Valley and South Midlands Annual Plan 2015-16

Host Organisation Oxford University Hospitals NHS Trust

PartnerOrganisations -Members of thePartnership Group

'1. Berkshire Healthcare NHS Foundation Trust2. Buckinghamshire Healthcare NHS Trust3. Milton Keynes Hospital NHS Foundation Trust4. Oxford Health NHS Foundation Trust5. Oxford University Hospitals NHS Trust6. Royal Berkshire NHS Foundation Trust

Other affiliatedpartners

(eg CCGs/Socialenterprises)

1. NHS Aylesbury Vale CCc2. NHS Bracknelland Ascot CCG3. NHS Chiltern CCG4. NHS Milton Keynes CCG5. NHS Newbury and District CCG6. NHS North and West Reading CCG7. NHS Oxfordshire CCGL NHS Slough CCG9. NHS South Reading CCG10. NHS Windsor, Ascot and Maidenhead CCG11. NHS Wokingham CCG

Host organisation Accountable Officer for CRN: Thames Valley and South Midlands

Name: Sir Jonathan l\richael Contact details

Chief Executive's Office,Level 3 John Radcliffe HospitalOxfordox3 gDUE m a il: J o n athan.M i c h ael @o uh. n hs. u kIel:01865 22'1000

Host nominated Executive Director for CRN: Thames Valley and South Midtands

Name: Dr Tony Berendt Contact details

Dr Tony BerendtI\4edical DirectorChief Executive's Office,Level 3 John Radcliffe HospitalOxfordox3 9DUE m a i I : to nv.beren dt@ou h,n h s. u kTel:01865 572876

Job title: lvledical Director

CRN: Thames Valley and South Midlands Clinical Director(s)

Name: Dr Belinda Lennox Contact details:Department of PsychatryUniversity of OxfordWarneford HospitalHeadingtonOxfordox3 7JX

E m a i t : be!!!!3!e!!9I@25Y9!E!4TeL o1a65 226491

Dr Andrew Protheroe

Co-Director

Contact detaib:University of Oxford Department of OncologyOxford Cancer & Haematology CentreThe Churchill HospitalHeadingtonOxfordox3 7LJ

Em aiL a nd rcw -proth e rce@ m e d on c, ox. ac. u k

Ielr 01865 572300

CRN: Thames Valley and South Midlands Chief Operating Officer

Name: Valerie Woods Contact details:NIHR CRN: Thames Valley & South MidlandsFirst Floor, The l\ranor HouseThe John Radcliffe HospitalOxfordox3 gDZ

Em ail : val.woods@ouh,nhs.uk

Tel: 01465223292

Mob: 07774 751572

To be completed by the Host organisation

Please briefly outline the process of engagement and consultation with LCRN Partnersand other stakeholders regarding the submifted LCRN 2015-16 Annual Plan and localrecruitment goals

As port ofthe plonning process we have-

-developed plon in conjunction with the LCRN Executive Group, Clinicol Reseotch Leods ond

O pe roti onal M o n og e me nt G rou p

-discussed plonning with trust R&D Monagers ot meeting in Februory 2015

-distributed both initiol ond finol droltto Partnership Group members and R&D Mdnogers for their

input ond comment

-metwith our Portnerchip Group PPIE representatives ond requested theirleedbock ond input to boththe initiol ond finol dtofts

-recruitment goolsfor eoch Speciolty ond the LCRN overullhove been informed by on onolysis ofcurrent studies. study pipelines ond potentiol Ior growth and in o series ol specific plonning meetingswith eoch divisionol Reseorch Delivety Monoger and Clinical Leod. Locol recruitment goolsforeoch

ttustwillbe discusse d furthe r ond linalised once the 2014/15 doto cut hos been token.

The plon wos initidlly tobled for fomol opprovol ot the OUHT March Boord meeting, but due tothechonge in the submission timetoble, this will now be included in the Moy Bootd meeting ogendo.

Similorly, we hove rcscheduled our Morch Portnership Group meeting until 23d Aptilwhere we expect

the plon to receive Iormal opprovol.

Nominated Executive Director Assurance

LCRN Host organisation nominatedExecutive Director signature confirmingthe following are in place for the LCRN:

. an assurance framework and riskmanagement system;

. robust and tested local businesscontinuity arrangements;

. an Urgent Public Health ResearchPlan.

Dr Tony Berendt

l\.Iedical Direcior

Confitmation of approval of the Annual Plan by the Host organisation Board and byLCRN Partnership Group (meeting held on 28rh April 2015)

Name: Dr Tony Berendt

Email:to n y, berendt@o uh. nhs. u kTel: 01865 572876

Role: Medical Director

Signature: l- -+k Date: 23d June 20'15

Contact for any communication regarding the CRN: Thames Valley and SouthMidlends Annual Plan

Name: Val WoodsEmail: [email protected]: 01865 223292Mob: 07774 751572

Role: Chief Operating Otficer

NIHR CRN: Thames Valley and South Midlands Annual Plan 2015-16

Table of Contents Table 1: LCRN plans and goals for contributing to NIHR CRN High Level Objectives ........................... 1 

Table 2: LCRN plans to contribute to the achievement of NIHR Clinical Research Specialty 

Objectives ............................................................................................................................................... 5 

Group 1: Increasing the breadth of research engagement in the NHS .............................................. 5 

Group 2: Portfolio Balance .................................................................................................................. 7 

Group 3: Research Infrastructure ..................................................................................................... 10 

Table 3: LCRN plans against the Operating Framework...................................................................... 13 

Table 4: LCRN Patient and Public Involvement and Engagement Plan .............................................. 19 

Table 5: LCRN Continuous Improvement Action Plan ......................................................................... 24 

Table 6: LCRN Workforce Plan ............................................................................................................. 25 

Appendix 1: LCRN Risk Register ........................................................................................................... 26 

Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC ............ 30 

CRN: Thames Valley and South Midlands Annual Plan 2015-16 

1  

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 LCRN target

40,000

Aspirational target

43,000

Rationale for targets

The target of 40,000 is slightly below the actual achieved for 2014/15 but still reflects the fact that the LCRN has higher recruitment per head of population than most other regions. It has been compiled based on-

latest intelligence on pipeline and recruitment available an updated detailed assessment by Specialty and by trust takes the reduction in acute trusts from 5 to 4 in the region into account reflects reliance on high recruiting studies to achieve the overall recruitment target takes account of all known studies in the pipeline

Local activities for 2015/16

Implement robust pipeline systems to identify potential studies at an earlier point and ensure that study intelligence is shared with Research Delivery Managers (RDMs), Specialty leads, trust leads and others across all sites

Documented process to be rolled out by June 2015

Develop programme to encourage and support potential new Principle Investigators (PIs), to grow research capability and sustainability across all sites in the region

Programme to commence by June 2015

Agree working principle with partner organisations that new studies will be considered for recruitment in more than 1 site unless this is not feasible

To be discussed at Partnership Group meeting in April 2015

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% Review performance of studies against recruitment targets at LCRN monthly Industry Operations Meetings which are attended by Industry Operations Manager (IOM), Chief Operating Officer (COO) and RDMs and invoke escalation process for issues as appropriate.

In place

Improve data quality on national and local systems, including Central Portfolio Management System (CPMS) and Local Portfolio Management System (LPMS), to ensure that study targets, timescales and actual recruitment to date are all accurately reported.

Will be on-going in conjunction with the implementation plans for CPMS and LPMS

Develop specific ‘taskforce’ capabilities within/across each Division to provide enhanced support where feasible and to respond to short term recruitment issues

By March 2016

B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period

80% 80% Review study performance at the monthly LCRN Operational Management Group meetings and develop ‘taskforce’ capabilities within/across each Division to provide enhanced support to respond to short term recruitment issues

Monthly meetings already in place

Improved taskforce capabilities developed by March 2016

Within Oxford University Hospitals NHS Trust (OUHT), agree responsibilities, priorities and working arrangements between the newly appointed trust-funded RM&G Delivery Managers and the LCRN RDMs within each of the trust’s divisions with regard to the monitoring of time to target performance and addressing study blockages

To be agreed by 1st July 2015

Implement LPMS across the region and build interface with CPMS to ensure that one accurate source of study and recruitment data is being used for performance management and monitoring across the region

LPMS to be implemented by April 2015 with additional functionality, including CPMS interface, developed during 2015

2

Objective Measure CRN

Target LCRN Goal Specific key local activities for 2015-16 Timescale

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 LCRN industry team to lead and complete on current contract and costing harmonisation initiatives in collaboration with trust finance and contract teams to ensure that the LCRN region can offer streamlined systems and processes to commercial partners

By March 2016

Deliver programme of engagement events for commercial partners, including a high profile Industry event, to showcase the CRN’s national and local capabilities with regard to delivery of Portfolio commercial studies.

Event to be organised in collaboration with national CRN industry team and regional partners including Biomedical Research Centre (BRC), Biomedical Research Unit (BRU), Diagnostic Evidence Co-operative (DEC), Collaboration for Leadership in Applied Health Research and Care (CLAHRC), Academic Health Science Network (AHSN)

October 2015

Update the LCRN Industry Strategy in line with 2015/16 Performance Operating Framework objectives for Partnership Group approval.

Strategy to ensure alignment between individual trust and LCRN strategies, systems, processes and timelines for engaging with commercial partners and will incorporate specific Primary Care strategy

April 2015

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 The LCRN is already above the target level for this measure.

Some current studies in the region may not be Portfolio adopted so, in conjunction with trusts, we will continue to monitor and process-map the approval processes in trusts to ensure optimum uptake of the Portfolio ( as part of our continuous improvement work stream)

Quarterly monitoring

Mapping project to be completed by end September 2015

Engage with companies and investigators who have studies which have not been put forward for inclusion onto the Portfolio to identify problems and blockages

On-going

Prepare specific promotional materials featuring the benefits of the CRN and the LCRN and detailing the processes required for Portfolio inclusion

September 2015

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 Currently meeting this target.

Will focus on continuation of existing process throughout next financial year

On-going

Early planning to ensure that a smooth handover is experienced by researchers with the advent of the Health Research Authority’s (HRA) approval process

On-going

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% Review performance of studies against recruitment targets at LCRN Monthly Industry Operations Meetings which are attended by IOM, COO, and RDMs

Monthly meetings already in place

In conjunction with trusts, implement a ‘warning system’ from CPMS or LPMS data, to flag up when studies are nearing the 30 day limit if there has been no recruitment

Dependent on CPMS and LPMS timelines

Use Open Data Platform (ODP) to develop new reports on 30 day achievement (once CPMS in place) for inclusion in the LCRN monthly information packs

Dependent on CPMS timelines

B: Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued

80% 80% Implement LPMS in member trusts and build interface with CPMS to ensure that one accurate source of study and recruitment data is being used for performance management and monitoring across the region

Dependent on LPMS and CPMS timelines

                                                             See Operating Framework Clause 5.28 

3

Objective Measure CRN

Target LCRN Goal Specific key local activities for 2015-16 Timescale

In conjunction with trusts, implement a ‘ warning system’ from CPMS or LPMS data, to flag up when studies are nearing the 30 day limit if there has been no recruitment

Dependent on CPMS and LPMS timelines

Use ODP to develop new reports on 30 day achievement (once CPMS in place) for inclusion in the LCRN monthly information packs

Dependent on CPMS timelines

6 Increase NHS participation in NIHR CRN Portfolio Studies

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

99% 99% Maintain 100% achievement On-going

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

70% 70% All our trusts currently recruit to commercial studies except Milton Keynes Foundation Trust (MKFT) which has now been selected as a site for several studies and is actively submitting further Expressions Of Interest (EOIs). We will continue to offer them support to develop their capabilities to undertake commercial studies

100% of trusts to be recruiting to commercial studies by March 2016

Commercial activity by trust will be reported to the Partnership Group at each meeting Throughout 2015/16

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

25% 25% For 2014/15 we have 31.9% of General Medical Practices recruiting into CRN Portfolio studies but this ranges between CCGs from 3.6% to 57.1%;

Develop GP Champions role and collaborate with Department of Primary Care at Oxford University (DoPC) to increase GP engagement

Introduction of a performance management system to support identification of areas of need

Implementation of the Research Site Initiative (RSI) scheme

 

On-going

RSI currently being launched

Restructure Primary Care Delivery Team to enable provision of a region wide service and direct support to GP Practices

Completed by end June 2015

Introduction of enhanced monthly performance management system to support geographic identification of areas where there is little activity

By April 2015

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 1,600 Rationale for target

The target of 1,600 is slightly higher than the actual achieved for 2014/15. It has been compiled based on the latest intelligence on pipeline and recruitment available and an updated detailed assessment by trust.

The aspirational target for recruitment to DeNDRoN studies is 1,700

On-going

Local activities for 2015/16

Review all commercial study opportunities with robust feasibility to ensure that studies will achieve time and target

Continue to proactively support the OPDC – Parkinson’s cohort study – which runs at all acute sites in the LCRN. This enables the wider support of Oxford University-derived Parkinson’s research programmes, alongside on-going management of 4 Parkinson’s research interested databases

Work more collaboratively with the clinical research facility (CRF) at the Warneford Hospital, to drive a model where the DeNDRoN teams focus on recruitment and rating activities, with the CRF team taking on study coordination and study delivery activities for trials. This enables the DeNDRoN team to focus more on recruitment activities and delivering studies in the community, and overall building delivery capacity

May 2015 and

on-going

4

Objective Measure CRN

Target LCRN Goal Specific key local activities for 2015-16 Timescale

Build capacity in Berkshire Healthcare NHS Foundation Trust (BHFT) in order to take on more DeNDRoN studies, and use a whole network approach to support the BHFT team, using staff with letters of access from Oxford Health NHS Foundation Trust (OxHealth) and Royal Berkshire NHS Foundation Trust (RBFT)

By July 15 and

on-going

CRN: Thames Valley and South Midlands Annual Plan 2015-16 

5  

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 Sub-Specialty leads are currently being appointed to spearhead this work and an action plan will be developed We will also develop new reporting packs to track activity and anticipated pipelines in each Sub-Specialty and for each of our 4 acute hospitals

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% 3 of our 4 acute trusts are recruiting to at least one NIHR CRN Portfolio study

Planned activities include-

To appoint Children’s Research Nurse in the trust with no activity to start in Q1 of 2015/16

To increase Portfolio of studies in active trusts

To develop the role of the LCRN Senior Research Nurse to continue support of Children’s Research Nurses and engage new PIs

To continue to develop Portfolio of commercial studies in OUHT and RBFT and identify opportunities for MKFT and BucksHT

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% Engage research interested clinicians from MKFT and BucksHT to attend LCRN Critical Care Speciality research meetings that run alongside the thrice yearly Oxford Regional Intensive Care Society meetings. Identify observational studies on the Portfolio that might act as a means for MKFT and BucksHT to get Critical Care research up and running in their units. Run an LCRN conference / study day to inform about research studies completed / in progress and encourage networking of staff with an interest in research related to Critical Care from across the region. RDM to scan Portfolio for potential studies and communicate with research lead clinicians in intensive care units. The current research lead clinicians in intensive care units also hold consultant anaesthetic positions. Therefore encourage these teams to engage in Anaesthesia Portfolio studies.

1.4 Dermatology Increase NHS participation in Dermatology studies on the NIHR CRN Portfolio

Number of sites recruiting into Dermatology studies 150 Increase recruitment to non-commercial Portfolio studies across the region through widening clinician and participant awareness of studies, and simplified pathways of recruitment.

Increase recruitment to commercial studies through direct links between PI and industry and completion of SIFs through SPoC

Develop the role of band 7 research nurse towards higher management training for activities including grant applications and facility development

Collaborate with other specialties on joint projects; opportunities already identified with Musculoskeletal (MSK)

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% Recruit an LCRN ENT Specialty lead to fill the current vacancy.

Support the Lead Research Nurse based in OUHT to work with nurses from BucksHT and MKFT on recruitment into the Genetics of Otitis Media study.

Establish an LCRN ENT research identity with view to encouraging participation in Portfolio studies across trusts, by holding an initial meeting of ENT research active / interested staff from the various trusts and agreeing a format for regular future meetings.

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% Use the existing Oxford Region Gut Club forum (held three times a year) to provide an update on LCRN research activity and to encourage / support research interested staff from trusts outside Oxford to participate in Portfolio studies.

6

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

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% 2 out of 4 Trusts recruiting to at least one NIHR CRN Portfolio study

To identify an appropriate study and engage clinicians in 1 additional trust

Provide resource to enable the opening of 2 Portfolio studies at OUHT, with support for DGHs

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% The major trauma centre in the LCRN region is OUHT which is actively participating in recruitment.

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% Continue to support emergency departments within RBFT and MKFT both of which are currently recruiting to Portfolio studies. Engage with research-interested staff in the Emergency Department at Stoke Mandeville Hospital (BucksHT) to encourage them to become involved in recruiting to Portfolio studies. Offer and provide support in design of investigator initiated studies, to maximise the opportunities for inclusion onto the Portfolio Continue to facilitate the established LCRN Injuries & Emergencies Specialty Group meetings (held quarterly) and annual conference. Encourage research interested staff from all trusts to attend and participate in studies.

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 Studies are already open and recruiting at all trusts within the LCRN.

Activity will be maintained and further increased through active engagement with clinicians and research staff at regional meetings and events.

A process will be implemented to assess feasibility and deliverability of commercial studies so as to increase activity

There will be a rebalancing of skill mix to reflect demand from new studies. This will enable the team to maintain support for Vasculitis and Rheumatology studies, but also to increase recruitment from osteoarthritis, rehab and cross-divisional studies.

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% Provide support for the Sleep Study – a relatively large new study co-ordinated from Oxford and involving RBFT and BucksHT Build on research interest from Mandip Bindra and Richard Smith at Stoke Mandeville Hospital (BucksHT) to support involvement in Portfolio studies. Arrival at Stoke Mandeville Hospital of Markus Groppe - a new Medical Retina Consultant who previously worked with OUHT ( Prof McLaren) as an academic fellow - who is likely to be proactive in terms of research. RDM to scan Portfolio and liaise with R&D staff in trusts to find studies appropriate to the services / expertise in individual trusts. For example at MKFT there are consultants who are keen to participate in research studies but recognise that the studies would need to be aimed at patients with relatively basic problems. Patients with more complex problems are referred elsewhere. Research interested / active staff in other trusts to be encouraged to attend the regular research meetings held at the Eye Research Group Oxford (ERGO) with a view to creating a network-wide identify. Use this group to inform, encourage and support staff from other trusts to participate in recruiting to studies. Support ERGO to make patients aware of Ophthalmology research and develop database of patients with interest in research so information sheets about studies can be distributed directly.

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 region has 4 trusts with renal units associated with them, but these are all legally entities of either OUHT or RBFT. As such patients seen in MKFT or BucksHT are seen as OUHT or RBFT patients. All centres have information on research studies available to patients and some have patient groups associated with clinical service that the LCRN intends to approach with regards to supporting research activities.

7

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

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 acute trusts are participating in Portfolio stroke studies and the LCRN will continue to engage with them in order to promote participation in Portfolio research studies. OUH is beginning to build a stroke research registry to facilitate future stroke research.

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% Recruit three Research Nurses to vacancies created by departure of previous postholders. Create and support a new team to provide a flexible resource to work across trusts in the LCRN region. Ensure all staff involved in recruiting attend specialist training in recruitment of participants to surgery studies. Create a forum for research active / interested surgeons to meet to consider involvement in Portfolio studies. Expand this group to include surgeons from all trusts. RDM to scan Portfolio for appropriate potential studies and communicate with Speciality lead and relevant surgeons across the network.

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% The LCRN has plans to recruit a Specialty Lead and develop its Age and Ageing Portfolio but this may take some time since there are no active studies in the region

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 From latest published data, the LCRN is currently achieving approximately 11% against this target and it is unlikely therefore that this can be increased to 20% within the next financial year. Activities we will undertake to improve our achievement include-

new RDM appointed with effect from 1st February 2015

produce metrics to highlight the performance by acute trust to focus on areas of poor achievement

scan the study pipeline to identify and support new interventional studies

develop an additional flexible workforce within the LCRN with the capabilities and capacity to recruit to Cancer studies (including surgery studies)

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 From latest published data, the LCRN is currently achieving approximately 5% for this measure. Activities we will undertake to improve our achievement include-

new RDM appointed with effect from 1st February 2015

produce metrics to highlight the performance by acute trust to focus on areas of poor achievement

scan the study pipeline to identify and support new studies

develop an additional flexible workforce within the LCRN with the capabilities and capacity to recruit to Cancer studies

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 &

15 OUHT is the only site running children’s and young adults’ cancer and Leukaemia trials. We will seek to expand these studies if feasible to other sites

Radiotherapy studies are already open in OUHT, RBFT and BucksHT and we will endeavour to continue to run such studies in all our trusts

Trials in rare cancers are currently running in OUHT (Early and Late Phase Teams), RBFT and MKFT,

8

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

Young Adults Recruiting to cancer surgery studies is a key priority for the LCRN. 3 research nurses are currently being recruited to work for the network as a flexible resource. They will be tasked with developing the cancer surgery Portfolio, initially in Oxford

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 In the financial year 2014/15, the LCRN recruited into multicentre studies in all six sub-Specialties, we expect this to continue in 2015/16

The network is engaging with all trusts in the region to promote cardiovascular studies. All secondary care providers in the region have active research studies. The LCRN circulates studies trying to identify new sites on a regular basis to encourage participation. The LCRN have identified and engaged with specific trusts and clinical teams in the current financial year in order to grow participation in the region.

The Cardiovascular Specialty promotes research in the region by organising an annual research day to highlight cardiovascular research in the region, this is rotated around sites in order to encourage participation across the region

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 The LCRN regularly distributes diabetic foot studies to sites across the region, several sites are interested in these studies and there is active engagement with foot care teams including for commercial studies. RBFT were selected for the Leucopatch study in 2014/15, and were already supporting the HEELS study. There is a very active strategic clinical network initiative to improve diabetic foot care in the region, this objective synergises with this initiative.

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 All of the secondary care sites in the region are taking part in the ADDRESS2 study. As interventional studies become available on the Portfolio suitable patients are approached to participate in these studies. The network is actively supporting DRN827 which is led by Prof Steve Gough. The paediatric research group is supporting UKCRN16990 that recruits type 1 patients within 6 months of diagnosis and will be active in 2015/16, as well as several other T1 diabetes studies

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 Widen research activity to include more emerging Gastroenterology sub-Specialties associated with identified and appropriately experienced potential PIs including: Luminal (Travis, Keshav, Brain); Endoscopy (East); GI Bleeding (Jairath, Bailey); Oesophageal (Bird, Lieberman); Immunobiology (Simmons); Imaging (Slater). Support the development of the FINS study aimed at recruiting a relatively large number of people with faecal incontinence. Engage with Industry and support increase in number of commercial studies to evaluate new drugs aimed at Inflamed Bowel Disease. Support the development of more investigator-initiated studies.

Support PPIE initiatives to create a public / patient website and facilitate patient research meetings to consider current research priorities and studies.

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 The LCRN is participating in studies through the NIHR UK Rare Genetic Disease Research Consortium

Following staffing difficulties in 2014/15 there is a need to maintain study participation and recruitment and 2 new research nurses to be in post Q1 2015/16

We will engage clinicians in trusts across the region to identify barriers and promote solutions to improve patient access to study participation outside Oxford

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 The LCRN has active studies in Thrombosis, Bleeding disorders, Transfusion but there is potential for increased activity across the region.

We aim to identify an appropriate study and engage clinicians in 1 additional trust

9

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

We will provide resource to enable the opening of 2 Portfolio studies at OUHT, with support for other sites

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 Build on existing LCRN Hepatitis research Portfolio which includes academic and commercial studies in set up targeting Auto-immune disease, NAFLD and Viral Hepatitis. Provide support to the new consultant with the Hepatology team at OUHT, Dr Jeremy Cobbold, who has a specialist interest in non-alcoholic fatty liver disease (NAFLD). NAFLD is a current western epidemic and is opening up major new research opportunities. He has initiated a specialist NAFLD clinic which will help to facilitate recruitment to studies. Support the development of clinical cohorts and databases in all the major liver disease areas to ensure access to the right patients to optimise study recruitment.

Continue to support the regular (6 weekly) LCRN meetings involving the Oxford Hepatology team and researchers/clinicians from trusts across the region to ensure access for patients to research is communicated regionally. These meetings are currently attended by clinicians from RBFT and BucksHT. There is a need to encourage representation from MKFT.

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 Build upon existing active LCRN involvement in multi-centre anti-microbial resistance research studies including ARREST, CIVAS and OVIVA. Build links and facilitate better awareness, communication and co-ordination between the various groups in the LCRN area actively involved in research in the Infectious Diseases & Microbiology Specialty. Encourage local Chief Investigators (CIs) to have studies adopted on Portfolio. Offer and provide support in design of investigator initiated studies to maximise the chance of acceptance onto the Portfolio.

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 The LCRN will promote participation in M & E studies to investigators across the region. The clinical lead for M & E has arranged a research awareness seminar to promote greater participation across the region. M&E activity is expected to be one of the growth areas within Div. 2 over the next 12 months.

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% The LCRN does not currently have an active Portfolio of studies in this Specialty and is hampered by the absence of a dental school in the region.

We aim to appoint a Specialty Lead for Oral and Dental by the end of March 2015.

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

30% See above

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% Develop GP Champions role and collaborate with DoPC to increase GP engagement

Restructure Primary Care Delivery Team to enable provision of a region wide service and direct support to GP Practices

Introduction of an improved performance management system to support identification of areas of need

Implementation of the RSI scheme

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% The region has 4 acute NHS trusts with renal units associated with them, but these are all legally entities of either OUHT or RBFT. Thus, all centres either recruit patients into interventional studies or act as Patient Identification Centres (PIC) sites for OUHT or RBFT-led studies.

The LCRN will continue to promote the available Randomised Controlled Trials (RCT) studies across the region.

10

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

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

C.

80% As above

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 Develop support for researchers with specific interest Asthma and COPD. This is a relatively new topic of research for Oxford and the LCRN. The arrival of Dr Bafadhel and Prof Porvord with experience of, and interest in, Asthma and COPD research provides an important opportunity to expand research and recruitment in this area. Support involvement in existing multicentre Portfolio studies aimed at Asthma and COPD e.g. Brightling-3. Developing better links and understanding between primary and secondary care in relation to Asthma and COPD research in order to facilitate better access to patients. Encourage communication and co-ordination between research staff in the Critical Care, Infectious Diseases and Respiratory Disorders Specialties in relation to Pneumonia studies. Generate increased interest in Respiratory Disorder research outside of Oxford in RBFT, MKFT and BucksHT by means of a summit / event.

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 The LCRN regularly circulates information on studies looking for additional sites to all centres in the region. RCT’s are actively promoted and the development of a balanced portfolio at each site, with a mix of RCT and observational studies is encouraged. As previously mentioned a research registry for stroke patients is being developed at OUH at present to assist in this objective.

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 No HSRC centres in the region although some HSRC studies are active in the region

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

15 No HSRC centres in the region although some HSRC studies are active in the region

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 We have worked with the Cancer Strategic Clinical Network within the Local Area Team (LAT) to develop a robust process for leadership of the 13 sub-Specialties which is now clearly documented.

Jointly, we have worked to identify leads for sub-Specialties. As at 10th February 2015 we have named leads for 10 of the 13 sub-Specialties. For the remainder, the lead activity will nominally will fall under the remit of the PBOG leads whilst we seek more nominations. The role has a robust role description

A new RDM for Division 1 started on 1st February who will support this process

3.2 Anaesthesia, Perioperative Medicine and Pain Management

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

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

4 Engage with Oxford Deanery Anaesthetic Trainees (OxDAT) which organises training for Anaesthetist Specialist Registrars in the area. Encourage and facilitate OxDAT to build upon current activities to support recruitment into Portfolio studies. RDM to scan Portfolio for potential new studies and communicate with Clinical Lead and OxDAT.

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

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% With the support of the Join Dementia Research (JDR) project manager, execute a comprehensive JDR promotional plan, which includes raising awareness among the following key sectors-

NHS trust communications teams and events;

NHS clinical teams who care for people with dementia and wards/memory clinics; third sector organisations (eg Age UK, Young Dementia Research, Oxford Federation of Women’s Institutes, Thames Valley U3A, ARUK, Alzheimer’s Society networks); primary care – GPs and community hospitals; dementia advisors; dementia research awareness events). Locally support the national media launch with local activities

Use 2 existing JDR champions to maximise JDR promotion – identify a third champion in Berkshire.

Record and report on screening logs to monitor local study participation via JDR

Offer JDR to people who have signed up to existing research interested dementia/control databases in Berkshire and Oxon/Bucks

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% By March 2015, 14/28 staff will have attended rater induction events

Monitor registration on the register following attendance at rater induction events

Support local delivery of rater induction events and rating forums for existing raters using local practice leads (4 in region). Discuss with COO to ensure budget in place if external facilitators are required

Support local practice leads to participate in the national practice lead community, and allow sufficient time in work plan to do so

Ensure that local job descriptions include the requirement to conduct psychometric and/or global rating scales

Include rating development skills in staff objectives

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 The LCRN has developed and approved an Expedited Study Process for Urgent Public Health Studies.

An urgent Public Health Champion has been appointed – Dr Dushyant Mital.

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 Develop 2 practice leads to support the on-going development of rating skills (Oxford/Bucks and Berkshire) in staff across the region.

Ensure collaborative working and idea sharing between Mental Health and DeNDRoN rating practice leads.

We have 17 PANSS certified raters in the region; we must ensure that these certified raters have adequate opportunities to retain rating skills/competency by live experience in studies and use of PPI volunteers as appropriate

Rationally appraise NIHR resource use in Division 4 and map against our key objectives and potential means of achieving them

Pursue the integration of clinical care and research recruitment

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 Neurological disorders Specialty leads to identify local clinical leads. At the current time, we have suitable candidates who would be willing to support this activity.

Enable and support these leads to develop local engagement and capacity, particularly across DGHs

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 A Midwife Champion has been identified in the LCRN and has participated in the national discussions held to date

Engage with Clinical leads within the 4 trusts across the region to increase participation in both commercial and non-commercial obstetrics and gynaecology research

Provide opportunities for research midwives and nurses to collaborate more closely and cross work between obstetrics and gynaecology studies

12

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

Provide training, education and networking opportunities to research nurses and midwives across the region through a bi-annual Division 3 meeting

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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

The Host trust’s internal auditors are KPMG. They have been provided with all the necessary internal audit guidance by the LCRN.

The COO met with KPMG to agree the scope of the initial audit. This was carried out in February/March 2015 and the audit report is awaited.

No further formal internal audit work is anticipated for 2015/16, unless particular issues or concerns are raised but there will be a programme of work by the Host R&D Finance department to provide assurances regarding the accuracy of financial returns received from Partner organisations

First internal audit completed and report

finalised

R&D Finance work programme agreed

By end April 2015

Activities to be completed throughout

2015/16

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

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

The Cross Divisional and Support Services Team Manager is the link person for the CRN Study Support Service programme. Information will be cascaded down via the monthly Operational Management Group meetings to the other divisions and will form part of the cross divisional update at each meeting to all Research Delivery Managers. Information will be cascaded to all trusts via the monthly RM&G

On-going On-going

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as specified by the national CRN Coordinating Centre. The Host organisation shall ensure that the 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.

Manager meetings.

If required, and dependent, on future developments, additional meetings to discuss the programme of work will be arranged. When sufficient clarity is available for researchers a separate programme of engagement will be designed

To ensure that all partner organisations follow the agreed CRN national systems, Standard Operating Procedures and operating manuals in respect of research delivery, the following key actions will be in place-

On-going oversight by the RM&G Lead Manager (Adeeba Asghar)

work with trusts to identify any non-compliant processes and systems

exception reporting to the Executive and Partnership Groups to highlight any areas of non-compliance, concerns or potential duplication of activities

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

The LCRN is committed to the efficient and speedy implementation of this service building on initiatives already on-going within the region. We already operate a lead network function providing a service to chief investigators and study teams, for particularly multi-site studies, and we will build on this to deliver the new services required by the CRN. An initial structure for the provision of these functions by the LCRN has been prepared for discussion and agreement.

The support services required by local teams and researchers will be delivered both by staff funded in the local trusts and by LCRN core team and we will work with partner organisations to develop our plans in line with the most recent national guidance from the CRN

Cross Divisional team structure for the study

support service

Operational plan agreed by Partnership

group

Transition of core RM&G staff into Study support service roles.

By end September 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

The Thames Valley has two trained AcoRD specialists in addition to the AcoRD Lead who sits on the national project board for implementation. The networks is committed to improving the cost attribution for studies led from the region in line with the AcoRD guidance, to this end the network: Engages as early as possible with researchers in the funding

application process to offer initial advice at the initial round of application supplemented by more in depth support at full application.

Promotes workshops on cost attribution for researchers with two presently planned in trusts in the region to increase the general knowledge base amongst research staff.

Promotes the principle that the cost attribution should be undertaken once by the Lead Network. Costings undertaken by other networks will be accepted by the Thames Valley and South Midlands and reciprocal agreement would be expected.

Engage closely with the finance departments of trusts to facilitate and mutually agree cost attribution.

Offers a cost attribution service to all researchers irrespective of funder.

Seeks to engage as widely as possible with all stakeholders to include RDS, CTU and University colleagues.

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

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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

Where possible the network will seek to reduce duplication of local checks. The network currently operates a single network assurance for all primary care studies which has prepared this area well for the smooth transition into the HRA. The monthly RM&G Manager meetings will be used to discuss the implementation plans of the HRA approval and assessment processes. These will be attended by the local HRA champion. It is envisaged that core staff will be transitioned into study wide activities for the study support service within the Cross divisional team.

On-going On-going

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 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.

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.

The network manages all local feasibility information through a bespoke tracker which will be revised with the advent of the CPMS system. Rates of return of site interest and non-return of site intelligence are monitored on a monthly basis for report to the Industry Operations Meetings. The tracker should resolve incidents reported of non-return. Furthermore: All non-returns in this financial year will be investigated. The LCRN tracker data will be fully reconciled with reports

from CRN CC. Our initial review suggests that there are several data discrepancies between the data from CRN CC and the local tracker information which indicates significantly higher response rates than those which have been reported by CRN CC

Separate meetings arranged with Divisions 1 and 2 to analyse process flows.

Revision of tracker to include feasibility

requests sent.

Meetings with Divisions 1 and 2

1st April 2015 and on-going

Provide details of local strategies for achieving LCRN wide usage and adoption by Host and Partner organisations of the NIHR CRN costing template

LCRN wide usage and adoption of the NIHR CRN costing template has been achieved.

Industry Operations Manager to seek

confirmations from all trusts

Confirmation by 1st April 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 Rohan van der Putt ([email protected]). This is a funded PA

Parkinson’s disease: Dr Michele Hu ([email protected]). This is a funded PA

Huntington’s disease: TBC, Helen Collins interim ([email protected])

Motor neurone disease: TBC, Helen Collins interim ([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

                                                            2 Information on recent performance provided by national CRN Coordinating Centre on 30/01/15 

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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

The Chief Operating Officer of the LCRN (Val Woods) is the senior leader with responsibility for PPIE within the LCRN whilst a

replacement for Chris Hille is appointed

Val Woods

Mobile 07776 465940

[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 is not treated a separate work programme but as an underlying foundation for the LCRN’s on-going work. The network has numerous projects and areas of work that come under the area of continuous improvement. Work is presently underway to identify and list these on the CRN website.

A continuous improvement working group will be instigated to provide support to the numerous staff engaged on these activities. The green belt 6 sigma training will be used to support several initiatives in this annual plan.

N/A N/A

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)

Provide via completion of Table 5

Provide details of continuous improvement projects to be delivered locally in 2015-16 (via CRN Central)

Please submit details by adding to the CRN CI site

Workforce, Learning and Organisational Development

The Host organisation will develop a workforce plan for LCRN staff that will enable a responsive and flexible workforce to deliver NIHR CRN Portfolio studies. This will be developed in partnership with Local Education and Training Boards (LETBs) and other stakeholders and other local learning providers, including Academic Health Science Networks (AHSNs)

10.1-10.10 Provide a workforce plan in line with agreed format and guidance

Provide via completion of Table 6

Provide the name and contact details for the senior leader with identified responsibility for LCRN workforce development

Helen Collins

Mobile: 07825 356499

Email: [email protected]

N/A N/A

Information Systems The Host organisation must ensure that appropriate, reliable and well maintained information systems and services are in place and fully operational as specified

13.1-13.19 Confirm LPMS systems are live and operational as required

The LPMS options appraisal was presented to OUHT and the Partnership Group at the end of November 2014. The Group concluded that we should continue to invest in the Joint Research Office (JRO) Portfolio System which already has wide scale adoption in the Host trust and in joint work with Oxford University. We therefore sought a waiver from the trust's standing financial instructions to procure LPMS from the existing supplier (Baseline Software Ltd) on the fair grounds of standardisation and compatibility with existing service.

Baseline Software Ltd has registered as a LPMS supplier with the NIHR CRN. They are now extending the JRO Portfolio System to work across the LCRN and interface to CPMS. They expect to implement this version in Q1 2015/16

Developing new functionality may take longer. Once CPMS is live, we build required interfaces between CPMS and LPMS and better assess the areas where additional functionality is required from LPMS

N/A N/A

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Confirm arrangements are in place for provision of an LCRN Service Desk function and provide contact details

Support for IT systems is currently dealt with by the Host IT department service desk facility. A series of meetings has also held with Host organisation to explore the establishment of a separate ‘CRN service desk’ which would triage all LCRN-related calls relating to Host systems, any other local solutions used by the LCRN and the new LPMS system through a single system, the performance of which would be monitored by the LCRN Information Systems Manager. This is scheduled for further discussion at the forthcoming LPMS Steering Group meeting in April 2015 and would be implemented once the LPMS has been fully rolled out across the region

N/A N/A

Provide the name and contact details of the identified lead for the Business Intelligence function

Dr Mark Dolman

Mobile 07776 477724

[email protected]

N/A N/A

Engagement and Communication

It is the responsibility of the Host organisation to ensure that there is a specialist, experienced and dedicated communications function to support the work of the LCRN, with a sufficient budget line. The Host organisation will support the development and implementation of the NIHR CRN Strategy for Communications and ensure that the LCRN communications function develops and delivers a local communications delivery plan that recognises the LCRN’s position as part of a national system. The plan should also encompass local delivery of national NIHR/NIHR CRN campaigns.

14.1 Describe the dedicated communications function the LCRN has in place

The LCRN has 2 PPI and Communications Managers who support initiatives across all areas

A senior lead is currently being appointed to provide leadership for this area to maximise opportunities to communicate and engage with internal and external stakeholders across the region more effectively

N/A N/A

14.2 Outline up to 5 priorities/priority activities contained in the LCRN’s local communications delivery plan

Establish a high level PPIE Reference Group with input from across the region/Specialties/trusts to help develop, deliver and oversee the LCRN’s communication and engagement plans

Develop a new internal engagement programme to address gaps left by the transition to the new LCRN governance structures and capture opportunities to network more creatively across the region

Develop and implement an effective communications strategy across all media which spans across all 3 counties and aligns better with communication strategies with other local networks and trusts (e.g. BRC, BRU, CLAHRC)

Produce a comprehensive plan for the development, distribution and usage of promotional materials to promote the activities of the network

Implement a specific communications plan to target awareness raising of the LCRN’s activities across all primary care settings

Progress on all activities to be reviewed

at end of March 2016

14.3 Budget line identified in Annual Financial Plan for 2015-16

N/A N/A N/A

Information Governance

Actively promote and enable good information governance relating to all areas of LCRN activity

15.2 Provide the Information Governance Toolkit 2013-14 (version 11)3 score for the LCRN Host organisation and confirmation of attainment of Level 2 or above on all, or any exceptions which arise from or impact on LCRN-funded activities

Final 2013/14 score of Host organisation was 86%, which equates to level 2 attainment overall. Confirmation received that all requirements met this level of attainment.

15.5 Provide a copy of the LCRN’s documented process for reporting information governance incidents arising from LCRN-funded activities to the national CRN Coordinating Centre

Please submit as Appendix 2 to your plan

15.8 Provide the name, email address and contact number(s) for the individual with specialist knowledge of information governance identified to respond to queries raised relating to LCRN-funded activities

Dr Christopher Bunch

Consultant Physician and Caldicott Guardian Oxford University Hospitals NHS Trust

[email protected]

01865 221343

N/A N/A

                                                            3 https://www.igt.hscic.gov.uk/ 

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15.9 Provide details of information systems utilised in LCRN activities and assurance/evidence that these are in line and comply with the 2013 NIHR Information Strategy4

Information systems used by the network include RDMIS, Open Data Platform, SharePoint and the hub/Google platform. The network is actively seeking to progress to the national service offering of the hub and is project planning migration of all shared e-mail addressed to NHS net and all files currently stored on host shared drives will be migrated to the Google Platform during the course of Q1/Q2 2015/16 financial year. Host shared drives will then be decommissioned The network preferentially accesses the hub whenever possible and supports the movement of central documentation from SharePoint files to the hub and the eventual decommissioning of the former. ODP is seen as a vital resource for the network and wider access is recommended to the wider research community working on portfolio studies.

N/A N/A

                                                            4 https://docs.google.com/a/nihr.ac.uk/file/d/0B6w0JTB5jHBSSldZT0Qyc05lVms/edit?usp=drive_web

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Table 4: LCRN Patient and Public Involvement and Engagement Plan 2015-2016

Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Promote research opportunities in line with the NHS Constitution and inform patients about local research opportunities

Key actions- Milestones-

Hub/websites established to promote participation in research opportunities and PPIE campaigns

Project plan developed and sites set up. Guidance on usage and promotional activities in place

By end Q2 2015/16

Information Systems Manager and Lead Communications and Engagement Manager

Promote patient stories in local and national press, newsletters and other media

Develop/promote at least 10 patient studies for local and national use

By end Q4 2015/16

Communications and Engagement Managers

Social media strategies revised to improve information available for patients/carers and public regarding opportunities for involvement and participation

Revised strategy agreed and actions in place

By end Q4 2015/16

Lead Communications and Engagement Manager

Promote OK to Ask across the region

Active engagement by members trusts in campaign with follow-on publicity

May 2015 Communications and Engagement Managers

LCRN annual event to be focussed on PPIE

PPIE Groups involved in developing agenda and running event

November 2015 COO

Strengthen links with trust Communications and PPI departments to maximise opportunities to raise awareness and develop collaborative approaches to engagement

Each trust department contacted and approaches for promoting activities jointly developed and agreed

By end Q4 2015/16

Lead Communications and Engagement Manager

Outcomes-

Patients, carers and the wider public better informed about our activities

PPIE further embedded as core business in work of LCRN and CRN

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Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Raising our profile and reputation Increase in demand for, and participation in,

research studies Improved collaboration with stakeholders

Actively engage and involve patients, carers and the wider public in all aspects of the LCRN and wider research endeavours

Key actions- Milestones-

Ensure that PPIE is embedded in development and approval of key LCRN strategies, plan and reports

PPIE representatives on Partnership Group are routinely consulted on key plans, reports and strategies

By end Q1 2015/16

COO

Establish PPIE Oversight Group for the LCRN with membership drawn from Partnership Group patient representatives and those involved in other aspects of the LCRN’s activities to help LCRN to develop and oversee delivery of PPIE initiatives and plans and foster stronger culture of collaborative and joined up working

Formal meetings held with Oversight Group and ToR agreed

By end Q2 2015/16

Lead Communications and Engagement Manager

Continue to provide support to local engagement groups within specific disease areas

Active local groups supported from core team on on-going basis for Cancer, Diabetes and DeNDRoN specialties

ongoing Communications and Engagement Managers

Complete current work with AHSN, BRC,BRU, CLAHRC, trusts and other groups within the region to provide comprehensive and streamlined approach for PPIE activities with clear signposting for patients, carers and members of the public

Signposting/roadmaps in place and promoted across region

By end Q2 2015/16

Communications and Engagement Managers

Produce common expenses policy for region-wide use by above groups

Implemented for consistent use across region (where possible)

By end Q2 2015/16

COO

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Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Develop specific approach for PPIE activities within primary care settings

Extended lines of communication within Primary Care (including CCGs) with specific engagement/promotional programme in place

By end Q2 2015/16

COO

Outcomes-

LCRN strategies and plans are better informed as result of PPIE input

Stronger patient voice with wider ‘reach’ Stronger alignment and commitment with regard

to PPIE activities from stakeholders across the region

System-wide approach with more consistency (e.g. expenses)

Gather feedback from participants in studies as well as patients, carers and the public, directly involved in supporting study delivery

Key actions- Milestones-

Complete develop of patient experience questionnaire for participants in studies to provide feedback on regularly basis

Questionnaire(s) approved and in use in at least 50% of trusts

By end Q4 2015/16

Lead Communications and Engagement Manager

Ensure that Patient / carer case studies and stories are gathered, collated and analysed on an on-going basis and captured in communication activities. Contribute to the national CRN ‘Patient Stories Campaign’

Develop/promote at least 10 patient studies for local and national use

By end Q4 2015/16

Communications and Engagement Managers

Participate in region-wide project (chaired by AHSN) to develop a common understanding and shared approach to PPIE recording & impact in the region

As per project plan (still in development)

TBA Communications and Engagement Managers

Create further opportunities for participants to provide feedback and general comment on the LCRN’s activities and ensure that feedback is

Ensure that Twitter accounts etc. are active across region and that all PPIE communications and promotional activity contains easy-to-use details for

By end Q2 2015/16

Communications and Engagement Managers

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Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

appropriately acknowledged (already in place with Cancer and Diabetes LCRN patient groups).

contacting the LCRN and acknowledging contributions

Outcomes-

PPIE feedback is properly valued LCRN strategies and plans are better informed

as result of PPIE input Drives culture of continuous improvement Stronger patient voice

Count how many actively involved patients, carers and the public access NIHR CRN learning and development resources

Key actions- Milestones-

Attendance at specific training events measured and feedback collected

Metrics reported to Partnership Group meeting

By end Q4 2015/16

COO

Develop, promote and measure access to E-Learning opportunities, to include national and LCRN initiatives (e.g. building on LCRN workforce induction and development programmes)

Initial E-Learning modules available and process in place to measure take-up rates

By end Q2 2015/16

COO

Capture attendance metrics from all other events and meetings that involve PPIE (including those that are managed by core LCRN team and those supported by network members across the region

Metrics being collected on regular basis and analysis shared with Partnership Group

By end Q4 2015/16

Lead Communications and Engagement Manager

Complete induction programme for newly appointed patient representatives on Partnership Group

Process completed and feedback collected

By end Q1 2015/16

COO

Survey patients, carers, the public and our researchers to identify further learning & development needs and opportunities

Survey distributed to all contacts and feedback analysed

By end Q3 2015/16

Lead Communications and Engagement Manager

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Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Outcomes-

Success can be properly measured Supports continuous improvement in quality and

scope of resources

Values PPIE involvement and feedback

Support the development and implementation of the national NIHR CRN Strategy for PPIE

Key actions- Milestones-

Update this PPIE plan and align with NIHR CRN strategy once the national strategy been approved

LCRN strategy updated and discussed at Partnership Group meeting

By end Q3 2015/16

COO

Ensure national strategy is circulated widely across stakeholders and can be accessed easily

Strategy available on intranet and internet websites, circulated to all PPIE contacts and shared with regional groups

By end Q2 2015/16

COO

Promote the ‘NIHR Patient Research Ambassador’ initiative

50% of trusts to have adopted ‘Patient Research Ambassador’ initiative and embedded the approach within their organisations

By end Q4 2015/16

Lead Communications and Engagement Manager

Appoint Lead Communications and Engagement Manager to engage in national initiatives

Recruitment Process complete and manager in post

1st September 2015

COO

Outcomes-

Enables best practice to be developed, shared and implemented

Drives culture of continuous improvement Strengthens patient voice National and local strategies and plans will be

better informed

Improves collaboration and consistency

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Table 5: Continuous Improvement Action Plan 2015-2016

Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Scoping of all continuous improvement projects and initiatives throughout Cross Divisional team and all Divisions

Item for the Operational Management Group meeting. Research Delivery Managers requested to supply details

May/June 2015 Harriet Savage

Recording all continuous improvement projects on the national website

Dependent on previous action 30/6/15 Harriet Savage

Training of 3 staff for green belt Lead Six Sigma. Attaining national training. Identification of appropriate projects

31/5/15 Mark Dolman

Completion of a Cohesive network continuous improvement strategy for the Thames Valley and South Midlands

Consultation with continuous improvement group. Consultation with Trusts

Strategy for sign off by partnership group 30/10/15 Mark Dolman

Establishment of a system for monitoring and registering new continuous improvement projects in order that the benefit can be realised comprehensively across the network and duplication minimised.

To be driven by continuous improvement group 30/6/15 Harriet Savage

Analysis of overlap and inclusion of Workforce Development in any strategic operations.

Discussion in workforce development meeting On-going Harriet Savage

Establishment of a continuous improvement group with ToR for the network

Representatives to be sought from all divisions and cross cutting team

30/4/15 Mark Dolman

Sourcing of a standard suite of project management documentation to be used for continuous improvement

National advice and availability sourced in the first instance. Correct branding added before availability

31/7/15 Harriet Savage

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Table 6: LCRN Workforce Plan 2015-2016

Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Delivering network business

Consolidate and deliver Induction programme

Webinar delivery – each month, effective Feb 15. Keep updated and review in light of evaluation

IT training – include as part of programme by June 2015. Look at webinar format

Working in the CRN workshop

Meet and Greet: finalise signposting document, then formulate Meet and Greet plans

Every month

NIHR hub, CPMS, LPMS, excel training – start delivering by June 2015, and monthly thereafter depending on need

Roll out as per local need, likely to be 1 in every 6 weeks, once backlog has been cleared

By July 2015

Helen Collins/Nancy Hopewell

Delivering network business

Deliver Fundamentals of Clinical Research Nursing

Subject to quality of training materials delivered by the national team, deliver first 2 day course 25/26 March.

Deliver to RNs who have been in post <18 months

Roll out as per local need, likely to be 1 in every 8 weeks, once backlog has been cleared

Nancy Hopewell/Sally Beer

Delivering network business

Deliver Fundamentals of Clinical Research

Develop local training to ensure equity of training opportunities across local workforce

Aim to finalise material/format by November 2015, then roll out according to local need thereafter

Helen Collins + TBC

Regulation and Safeguarding

GCP programme

Introduction to GCP version 3 to be piloted 8 April 2015, then GCP facilitators trained locally on 22 April 2015, then rolled out across region

Refresher GCP course: national update planned for late 2015. Implement changes locally as per national timescales

PI GCP: awaiting national launch. Implement changes locally as per national timescales. Local clinical director is keen to use this to support PI engagement

April 2015

As per national timescales

As per national timescales

Nancy Hopewell and local GCP facilitators, + Dr Belinda Lennox

Regulation and Safeguarding

Valid Informed consent

Review current local course and update By September 2015 Nancy Hopewell/Sally Beer

Delivering network business

Let’s Talk Trials

2-3 facilitators to attend national training in June/July 2015

Develop Roll out programme to start in October 2015

Nancy Hopewell

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Planned actions in 2015-16 Milestones and outcomes once actions complete Timescale Lead

Speciality specific and Responsive

Specialty specific courses

Rater training; Cancer Researchers Introductory course Continue to support these national programmes

Helen Collins – rater;

Nancy Hopewell - Cancer

Speciality specific and Responsive

Specialty specific courses

Continue to run where courses are available

Develop and run Training needs analysis survey to inform Specialty specific learning

Develop survey questions – May 2015

Open survey and collate/report results – July 2015

Each division to develop WFD strategy – by September 2015

Helen Collins, Tess John, David Porter, Nancy Hopewell

Delivering network business

Team building for core network team

Using “Working in the CRN” materials and other facilitators, develop and deliver core team building sessions

Refine content from December 2014, and deliver in April and September 2015

Val Woods/Nancy Hopewell

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Appendix 1: LCRN Risk Register NIHR Clinical Research Network 

Risk Register March 2015 

Owner of LCRN Risk Register: V Woods, Chief Operating Officer, LCRN Updated:   24 February 2015 Next Review:   May 2015  

 

 

Scoring legend  1  2  3  4  5 

Likelihood Over 12 months: Rare 

Over 12 months:Unlikely 

Within 3 – 12 months: Possible 

Within 3 months:Likely 

Within 3 months:Almost certain 

Consequence  Insignificant  Minor  Moderate  Major  Catastrophic 

 Risk Score (on averaged basis for all risks listed) Risk Level 

>15  Extreme Risk

8 ‐ 14  High Risk 

4 ‐ 7  Moderate Risk 

1 ‐ 3  Low Risk 

 

#  Risk Description 

Inherent (gross) 

Consequence of Failure to Manage  Activities to Reduce/Eliminate Risk 

Residual (net) Control Score 

(a‐b) 

Responsibility Likeli‐hood 

(1‐5) 

Impact 

(1‐5) 

Risk 

(a) 

Likeli‐hood 

(1‐5) 

Impact (1‐5) 

Risk 

(b) 

CRN1  Uncertainty around requirements for new study support service as HRA introduced 

4  3  12  Could be both operational and reputational risk to LCRN 

If a ‘quick start up’ approach is adopted by HRA before all systems/processes have been developed, there is a real risk of confusion for researchers 

Could destabilise and demotivate work teams 

 

monitor new requirements closely and plan workloads well ahead, reviewing level of resource as necessary 

keep Executive Group updated on any issues 

work with CRN CC on new arrangements 

work closely with HRA local Champion (Janet Boothroyd) 

4  2  8  4  Cross Divisional Manager 

CRN2  Cannot recruit or retain good staff due to high cost of living and low unemployment in the region 

5  3  15  Impact on resilience of LCRN 

Ineffective career planning 

Demotivating for existing staff due to work pressures 

re‐advertise roles if necessary 

advertise more widely than NHS jobs if required to improve quality of candidates applying for roles 

Work with Host  trust on retention policies/enhancements 

4  2  8  7  Cross Divisional Manager 

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CRN3  Continuing complexity in metrics and on‐going differences between metrics for DH and CRN 

5  3  15  Lack of LCRN buy in with trusts if focus on DH metrics and not CRN ones 

May reduce effectiveness of monitoring of performance against time to target and first patient visit 

Too much time diverted to debates on how performance is measured rather than focusing on problem solving 

 

work with CRN CC on concerns 

continue to highlight at national meetings 

develop effective systems for collecting data locally (eg LPMS) to meet all requirements 

4  2  8  7  Cross Divisional Manager 

CRN4  Cannot agree policy for ETC  5  3  15  Cannot run studies 

Reputational risk 

work with CRN CC 

further work with local stakeholders (LAT, CCGs) 

 

4  2  8  7  Cross Divisional Manager 

CRN5  Primary Care recruitment below national average 

5  2  10  Not achieving potential in the Thames Valley & South Midlands region 

Not meeting national objectives 

Losing momentum on Primary Care research 

 

deliver primary care strategy 

Strengthen links with GP groups – especially outside Oxfordshire 

closer working with LAT 

3  2  6  4  Clinical Lead/RDM for Division 5 

CRN6  Cancer recruitment below national average 

5  2  10  Not achieving potential in the Thames Valley & South Midlands region 

Not meeting national objectives 

Losing momentum on Cancer research 

 

better use of data to understand and performance manage 

improve processes for supporting follow up 

consider direct taskforce 

3  2  6  4  Clinical Lead/RDM for Division 1 

CRN7  Industry performance is below national average 

5  2  10  Not achieving HLOs 

Not achieving potential in the Thames Valley & South Midlands region 

Not meeting other national objectives 

Reputational damage and missed opportunities 

Impact in terms of RCF funding which further limits ability to grow commercial portfolio 

 

 

 

deliver industry strategy 

work collaboratively across the region with other NIHR funded bodies 

close working with Partnership Group 

better use of data to understand and performance manage 

hold regional industry conference 

3  2  6  4  Cross Divisional Manager 

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CRN8  Ineffective implementation of Google platforms and hub 

4  2  8  Lack of awareness of CRN activities 

Not using Hub to full potential or in line with national expectations 

Unable to access up to date information 

 

 

implement action plan to develop hub working locally 

work with CRN CC on technical issues 

3  2  6  2  Cross Divisional Manager 

CRN9  LPMS implementation will over run into 2015/16 

5  2  10  Will not meet CRN objectives 

Reputational risk 

hold meetings of LPMS Steering Group and Project Group 

as soon as CPMS implemented, agree scope of additional functionality required and build necessary interfaces asap 

 

5  1  5  5  Chief Operating Officer 

CRN10  Requests for SSC funding on new studies will outstrip ability of CRN to commit financial support, particularly moving into 2015/16 

3  3  9  Operational and Reputational risk 

Missed recruitment opportunities 

make guidelines clear 

signal early what can and can’t be done 

more work to consider costings at study development stage so that realistic expectations and common understanding can be set 

very close operational management of budget

retain contingency fund if possible to address urgent requests 

closer work with OUH R&D Finance to develop stronger systems that incorporate all funding sources (BRC, RCF, commercial, Grant etc) in decision making 

 

2  2  4  5  COO/RDMs/Cross Divisional Manager 

CRN11  Partnership Group meetings may not meet all CRN objectives 

3  2  6  Difficulties in making meetings all quorate 

Difficulties in scheduling 4 x meetings per year 

Chair is stepping down 

 

discuss plans for new chair at next meeting 

once in place, schedule meetings well in advance 

vary format to make meetings attractive and opportunities to showcase achievements 

2  2  4  2  Chief Operating Officer 

CRN12  Cannot fill posts or retain research  staff in OUH due to fixed contract length whilst at same time there are trust concerns that availability of research posts in OUH may be impacting adversely on their ability to retain staff in clinical posts 

3  2  6  CRN cannot attract or keep experienced staff 

Leads to disruptive staff turnover 

OUH cannot retain sufficient cover in clinical posts 

Policies for research staff and clinical staff are not in alignment 

 

 

 

work with OUH chief nurse on updating and co‐coordinating policies and approaches for attracting, retaining and developing research and clinical roles 

provide support through CRN workforce development initiatives 

2  2  4  2  Chief Operating Officer 

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CRN13  Insufficient space available at Churchill sites for research staff 

3  2  6  Cannot run studies if no space so impacts on delivery of recruitment objectives 

Adverse impact on team morale 

Staff leave due to poor working conditions 

 

‐raise at Executive Group meetings 

‐arrange meetings of all relevant stakeholders on Churchill site to find better solution 

‐offer ‘hot desk’ space in network office at NOC 

2  2  4  2  Chief Operating Officer 

CRN14  Implications of LCRN policy not to fund Clinical Delivery PAs in 2015‐16 

4  2  8  Clinician’s unable to source funding from other sources or embed in job plans 

Could impact upon morale 

Couple impact on study delivery 

 

‐raise at Executive Group meetings 

‐improve internal communications with Divisional RDMs and Clinical Research Leads to flag up and address potential issues at an early stage 

‐explore solutions and best practice from other LCRNs 

2  2  4  4  Chief Operating Officer 

 

CRN: Thames Valley and South Midlands Annual Plan 2015-16 

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Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC