CRN: Thames Valley and South Midlands Annual Plan 2015-16 Val Woods Chief Operating Officer 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 ............................................................................................................................................... 4 Group 1: Increasing the breadth of research engagement in the NHS .............................................. 4 Group 2: Portfolio Balance .................................................................................................................. 6 Group 3: Research Infrastructure ....................................................................................................... 9 Table 3: LCRN plans against the Operating Framework...................................................................... 12 Table 4: LCRN Patient and Public Involvement and Engagement Plan .............................................. 18 Table 5: LCRN Continuous Improvement Action Plan ......................................................................... 20 Table 6: LCRN Workforce Plan ............................................................................................................. 21 Appendix 1: LCRN Risk Register ........................................................................................................... 23 Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC ............ 23 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 1: LCRN plans and goals for contributing to NIHR CRN High Level Objectives 2015-16 Objective 1 2 Increase the number of participants recruited into NIHR CRN Portfolio studies Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time Measure Number of participants recruited in a reporting year into NIHR CRN Portfolio studies A: B: 3 Increase the number of commercial contract studies delivered through the NIHR CRN A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period Number of new commercial contract studies entering the NIHR CRN Portfolio CRN Target 650,000 80% 80% 600 LCRN Goal 40,000 80% 80% n/a Specific key local activities for 2015-16 Timescale 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 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 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 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 1 Objective Measure B: 4 5 Reduce the time taken for eligible studies to achieve NHS Permission through CSP Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies Proportion of eligible studies obtaining all NHS Permissions within 40 calendar days (from receipt of a valid complete application by NIHR CRN) A: B: 6 Increase NHS participation in NIHR CRN Portfolio Studies 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 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 Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued CRN Target 75% 80% 80% 80% LCRN Goal n/a n/a 80% 80% Specific key local activities for 2015-16 Timescale 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 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 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 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 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 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 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 100% of trusts to be recruiting to commercial studies See Operating Framework Clause 5.28 2 Objective Measure C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies CRN Target 25% LCRN Goal 25% Specific key local activities for 2015-16 Timescale to undertake commercial studies by March 2016 Commercial activity by trust will be reported to the Partnership Group at each meeting Throughout 2015/16 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 On-going RSI currently being launched Implementation of the Research Site Initiative (RSI) scheme 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 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 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 On-going 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 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 3 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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. 4 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 crossdivisional 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% 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% 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. 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. 5 ID Specialty Objective Measure Target 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% 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% LCRN activities and initiatives to contribute to achievement of objective(s) 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. 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 2.1 Ageing Increase access for patients to Ageing studies on the NIHR CRN Portfolio Proportion of Ageing-led studies which are multicentre studies 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 2.3 2.4 Cancer Cancer Increase the number of cancer patients participating in interventional trials, to support the national target of 7.5% cancer incidence Deliver a Portfolio of studies including challenging trials in support of national priorities Number of LCRNs recruiting at or above the national target of 7.5%, or with an increase compared with 2014-15 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 & Target LCRN activities and initiatives to contribute to achievement of objective(s) 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 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- 15 15 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) 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 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, 6 ID Specialty Objective Measure Target Young Adults LCRN activities and initiatives to contribute to achievement of objective(s) 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 subSpecialties 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 7 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. 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. Proportion of acute NHS Trusts recruiting into multicentre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 8 ID Specialty Objective B. Measure Target Proportion of Renal Units recruiting into multi-centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 80% LCRN activities and initiatives to contribute to achievement of objective(s) As above C. 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 subSpecialties 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. 9 ID Specialty 3.3 Dementias and Neurodegeneration (DeNDRoN) Objective Optimise the use of “Join Dementia Research” to support recruitment into DeNDRoN studies on the NIHR CRN Portfolio Measure The proportion of people identified for DeNDRoN studies on the NIHR CRN Portfolio via “Join Dementia Research” Target LCRN activities and initiatives to contribute to achievement of objective(s) 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 10 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 11 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 3: LCRN plans against the Operating Framework 2015-16 POF Area LCRN Governance Research Delivery Operating Framework requirement Operating Framework Reference Information required Planned LCRN actions/activities for 2015-16 or other requested information Milestones & outcomes once complete Timescale 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 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 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 Activities to be completed throughout 2015/16 On-going 12 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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- Provide a brief outline (1-2 paragraphs) of the LCRN’s plans for implementation and delivery of the Study Support Service 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 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 The LCRN is committed to the efficient and speedy implementation of this service building on initiatives already ongoing 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 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 13 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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. Delivering on the Government Research Priority of Dementia Patient and Public Involvement and Engagement (PPIE) 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 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 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 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 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 2 improvement in performance . 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 ongoing 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 Provide details of local strategies for achieving LCRN wide usage and adoption by Host and Partner organisations of the NIHR CRN costing template Please provide names and contact details for identified clinical Research Leads for each of these disease areas Provide a comprehensive patient and public involvement and engagement plan in line with agreed format and guidance Dementias: Dr Rohan van der Putt (Rohan.Vanderputt@oxfordhealth.nhs.uk). This is a funded PA Parkinson’s disease: Dr Michele Hu (michele.hu@ndcn.ox.ac.uk). This is a funded PA Huntington’s disease: TBC, Helen Collins interim (helencollins1@nhs.net) Motor neurone disease: TBC, Helen Collins interim (helencollins1@nhs.net) Provide via completion of Table 4 2 Information on recent performance provided by national CRN Coordinating Centre on 30/01/15 14 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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. Continuous Improvement (CI) Workforce, Learning and Organisational Development Information Systems The Host organisation will promote and sustain a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance 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 N/A N/A N/A N/A Val Woods Mobile 07776 465940 val.woods@nihr.ac.uk 9.1-9.6 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 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 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. 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 Provide a workforce plan in line with agreed format and guidance Provide the name and contact details for the senior leader with identified responsibility for LCRN workforce development Confirm LPMS systems are live and operational as required Provide via completion of Table 6 Helen Collins Mobile: 07825 356499 Email: helen.collins@nihr.ac.uk N/A N/A 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 15 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Engagement and Communication Information Governance 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. Actively promote and enable good information governance relating to all areas of LCRN activity 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 mark.dolman@nihr.ac.uk N/A N/A N/A N/A 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 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 14.3 Budget line identified in Annual Financial Plan for 2015-16 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 N/A Progress on all activities to be reviewed at end of March 2016 N/A Dr Christopher Bunch Consultant Physician and Caldicott Guardian Oxford University Hospitals NHS Trust chris.bunch@ouh.nhs.uk 01865 221343 N/A N/A N/A 3 https://www.igt.hscic.gov.uk/ 16 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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 17 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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 engagement and participation in clinical research across all stages of the research delivery pathway. Key Actions1. Complete current work with AHSN, BRC,BRU, CLAHRC, trusts, and other groups within the geography to confirm how/ where patient groups need to be represented and ensure comprehensive, clear and streamlined approach Regular region-wide meetings commenced in 2014 under stewardship of AHSN to develop this initiative Milestone – once comprehensive mapping document produced To be completed by end Q2 2015/16 Communications and Engagement Lead Manager 2. Produce common expenses policy for regionwide use by above groups Final drafts now being circulated for comments and local approval. Milestone - policy approved and adopted by LCRN and in use across all infrastructures By end Q1 2015/16 Communications and Engagement Lead Manager 3. Produce clear ‘signposting’ process in collaboration with partners above so that can promote opportunities for involvement and engagement more broadly and effectively across the geography and research delivery pathways Milestone – document in place and promoted widely for use By end Q1 2015/16 Communications and Engagement Lead Manager 4. Continue to engage with key local groups to provide input into and feedback on LCRN activities Milestone – active local groups being supported from core team on on-going basis for Cancer, Diabetes and DeNDRoN specialties Ongoing Communications and Engagement Managers Milestone - Induction meeting held and follow up session with clinical directors scheduled In April 2015 Chief Operating Officer Lay Representation within the Governance Structure of The Network Key Actions5. Complete induction programme for newly appointed patient representatives on Partnership Group 18 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16 6. Establish PPIE Reference 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 Milestones and outcomes once actions complete Timescale Lead Milestones – Formal ToR approved Membership agreed First meeting held This PPIE plan to be refreshed by that Group once in place By end Q2 Communications and Engagement Lead Manager Promote an increase in research awareness across the network Key Actions7. Develop a programme of work to measure public awareness and perception of clinical research across the region and develop an action plan to increase awareness and improve understanding over time. Milestone – develop approaches including an ‘attitudes survey’ (focus group or questionnaire-based) for use with key target groups ( eg sixth formers or research committed GP groups) and report initial findings to PPIE Reference Group and Partnership Group to inform future work streams by end Q4 Communications and Engagement Lead Manager 8. Promote patient stories in local and national press, newsletters and other media Milestone - Develop/promote at least 10 patient studies for local and national use By year end Communications and Engagement Managers 9. Ensure that PPIE is central to planning and delivery of LCRN events Milestone - PPIE involvement in LCRN conference in September 2015 September 2015 Chief Operating Officer 10. Promote OK to Ask across the region Work programme to support OK to Ask in place with plans to maximise opportunities to promote events that are happening and involve members of the extended LCRN teams and in each trust Milestone – successful delivery in May across region May 2015 Communications and Engagement Managers 11. Survey local schools, community groups, universities, hard to reach groups and capture opportunities for engagement Milestone – formal review of programme to be reported to Partnership Board By end Q4 Communications and Engagement Managers 19 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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 20 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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 21 CRN: Thames Valley and South Midlands Annual Plan 2015-16 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 22 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 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 8 ‐ 14 4 ‐ 7 1 ‐ 3 Extreme Risk High Risk Moderate Risk Low Risk Inherent (gross) # CRN1 Risk Description Uncertainty around requirements for new study support service as HRA introduced Likeli‐ Impact hood (1‐5) (1‐5) 4 3 Residual (net) Consequence of Failure to Manage Risk Activities to Reduce/Eliminate Risk (a) 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 Likeli‐ hood Impact (1‐5) (1‐5) Risk Control Score (b) (a‐b) Responsibility 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 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 Could destabilise and demotivate work teams 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 23 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 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 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 work with CRN CC further work with local stakeholders (LAT, CCGs) 4 2 8 7 Cross Divisional Manager 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 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 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 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 CRN4 Cannot agree policy for ETC 5 3 15 Cannot run studies Reputational risk 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 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 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 24 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 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 implement action plan to develop hub working locally work with CRN CC on technical issues 3 2 6 2 Cross Divisional Manager 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 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 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 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 Unable to access up to date information CRN9 LPMS implementation will over run into 2015/16 5 2 10 Will not meet CRN objectives Reputational risk 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 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 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 25 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 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 ‐raise at Executive Group meetings Adverse impact on team morale ‐offer ‘hot desk’ space in network office at NOC 2 2 4 2 Chief Operating Officer 2 2 4 4 Chief Operating Officer ‐arrange meetings of all relevant stakeholders on Churchill site to find better solution Staff leave due to poor working conditions 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 26 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC 27 1st Floor, Manor House The John Radcliffe Hospital Headley Way, Headington Oxford, OX3 9DZ Tel: 01865 223292 Email: crnthamesvalley@nihr.ac.uk Web: www.crn.nihr.ac.uk/thamesvalley 2015-16 Funding - Financial Commentary CRN: Thames Valley and South Midlands Background The LCRN received £13.5m for allocation across the region in 2015/16 which represents flat funding year on year. This paper summarises how the budget was developed and agreed. Explanation of how funding is allocated to Partner Organisations We requested financial submissions from each of our trusts and specialties, in a standard format comprising details on the following posts we currently fund posts they would ideally like funding a detailed justification for requests details of their current trust/specialty structures (including any non-CRN funded posts) details of recruitment by study and plans for 2015-16 We then considered these submissions alongside a more analytical review of performance in trusts/specialties which took into account a number of metrics including, study numbers, weighted and un-weighted recruitment (including known PIC activity and studies where recruitment numbers are not logged) both for 2014-15 on its own and also across the previous 2 years, any known complexity facts, anticipated current pipelines and plans/potential for growth. We also took into account the following key objectives a need to deliver the CRN High Level Objectives a need to support the national objective to deliver a more ‘balanced Portfolio’ across all specialties, NHS settings and geographies and ensure that funding is not too heavily skewed towards particular areas ensuring that we are only funding bona fide ‘service support cost’ activities and that, where appropriate, research is also being supported with monies from other funding streams – such as grant monies and commercial income a greater focus on funding nursing and support staff who are directly involved in the recruitment of patients to studies During the budget allocation process for this year we also decided to stop paying research delivery PAs for consultants as well as PAs for R&D leads. In our region we have historically only paid for these PAs in a few specialty areas / trusts. Therefore, in order to ensure equity across specialties and across the region, and also to increase the number of research delivery staff that we can directly fund, we intend to cease funding for these sessions for 2015-16. We will however continue to pay sessional time for those who are acting as our Specialty Leads or Divisional Clinical Leads, with regional responsibilities. Proposed budgets were then reviewed by the Executive Group and discussed with trusts/specialties prior to the proposals being finalised. We have also consulted with our Partnership Group members on the proposed trust allocations and agreed details of the final submissions with the R&D Managers in each of our trusts. Explanation of how funding for Primary Care-related activity is passed to independent contractors. The only independent contractors at present in the region who are in receipt of LCRN funding are GPs. These are paid directly by the Host from the LCRN allocation - upon receipt of valid invoices from GP surgeries and records are kept of individual payments within the LCRN core team. Nature, magnitude and likelihood of any financial risk The following points are of note the contingency within the return is limited (£162k) and will require careful management in year. The LCRN will again use its available network RCF strategically to manage financial risks during the year (and especially in Q1 and Q2) network RCF has been apportioned by CRN CC on a different basis this year and the LCRN has only been allocated a total of £377k, well below last year’s level. Thus, available RCF monies will require very close management. several budgets contain significant vacancy factors. These amounts are consistent with our experience of vacancy factors during 2013-14 and 2014-15 and in all cases these have been discussed in detail with trusts concerned. Trusts are fully aware of the need to submit break even financial returns at year end in line with the overall budget that has been allocated to them. V Woods Chief Operating Officer CRN: Thames Valley and South Midlands April 2015 CRN:Thames Valley and South Midlands Budget 2015/16 £k Delivery Funding to Trusts Berkshire Healthcare NHS Foundation Trust Buckinghamshire Heathcare NHS Trust Milton Keynes University Hosptial NHS Foundation Trust Oxford Health NHS Foundation Trust Oxford University Hospitals NHS Trust Royal Berkshire NHS Foundation Trust Primary Care Total Delivery Funding 445 930 600 860 6000 1100 880 10,815 Leadership and Management costs Management (COO, RDMs) Clinical Director(s) Core Network posts PAs for Divisional Clinical Leads PAs for Specialty Leads LPMS costs Training/office/PPI/events/comms 508 63 1230 75 330 81 90 Other Host Corporate Support Services Contingency Total Budget 161 152 13,504