Annual Plan

Transcription

1 Annual Plan

2 CRN: [North East and North Cumbria] Annual Plan Contents Table 1 LCRN plans and goals for contributing to NIHR CRN High Level Objectives p.1 Table 2 LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty Objectives p.5 Table 3 LCRN plans against the Operating Framework p.13 Table 4 LCRN Patient and Public Involvement and Engagement (PPIE) Plan p.20 Table 5 LCRN Continuous Improvement Action Plan p.22 Table 6 LCRN Workforce plan 6a Learning and Development Plan p.26 6b Workforce Intelligence Plan p.28 Appendix 1 Risk Register p.30 Appendix 2 Information Governance Incidents: action and reporting p.31 2

3 Table 1. LCRN plans and goals for contributing to NIHR CRN High Level Objectives Objective Measure CRN 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 Target 650,000 LCRN Goal Specific key local activities for ,625 Clinical Research Leads (CRLs) and Research Delivery Managers (RDMs) worked with Clinical Research Specialty Leads (CRSLs) to agree goals for each Specialty by Partner Organisation (PO) Goals were informed by current studies, plus those known to be opening in Specialties encouraged to set stretch goals Timescale Monthly reporting of all recruitment metrics (LCRN performance report), reviewed by Executive Group. In depth review of all performance metrics at Executive Group (division/month) Monthly Monthly reporting of recruitment metrics to CRSLs where recruitment failing development of local action plans, jointly developed by CRSL, RDM and POs Monthly 2 Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites 80% 80% Production of local monthly reports (open studies) to indicate RAG status and dissemination across Specialty, Divisions and PO Monthly review of open studies that are red or amber and production of a locally agreed action plan to address the issues Feedback to the national industry team errors and discrepancies for amendment e.g. omissions, incorrect dates and targets Liaison with sponsors or CRA where appropriate to facilitate action plans. Carried out by industry team and liaison with RDMs Monthly Development of new collaborative ways of working and enhancing recruitment to commercial studies e.g. Gastrointestinal collaborative working, training and development of PIC site strategy Launch 29/01/2015 pilot for 12 months PIC strategy launched for 12 months. Completion April 2016 B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period 80% 80% Production of local monthly report to indicate RAG status and dissemination across Speciality, Divisions and PO Monthly review of studies that are red or amber Follow the agreed NENC workflow regarding recruitment to time and target to include a locally agreed action plan to address the issues Liaison with Sponsors where required to facilitate action plans. Carried out by PO, R&D dept. and RDM Ongoing monthly Review success of locally agreed workflow to address issues around recruitment to time and target and amend as necessary RTT workflow introduced 10/2014 for 12 months. For review April Increase the number of commercial contract studies delivered through the NIHR CRN A: Number of new commercial contract studies entering the NIHR CRN Portfolio 600 n/a Industry team to work to sustain the development of new industry studies by promoting industry work, training and developing new staff/teams and liaising with POs within R&D and existing study team in new clinical areas Monitor this on a monthly basis via ODP and the industry RAG reports Ongoing monthly Development of MedTech initiative to increase interactions with SME and Med Tech companies to develop an increasing number of commercial research projects in conjunction with the AHSN and other regional services to support this sector Pilot for 12 months review end October 2015 Industry team work to increase the number of sites in NENC involved in commercial research studies by proactively promoting the commercial agenda and potential studies via POs, Clinical Monitored on monthly basis

4 Objective Measure CRN Target LCRN Goal Specific key local activities for Timescale Research Specialty Groups (CRSGs) and directly with clinical teams Harmonise set-up activities for studies running at multiple sites in the region e.g. streamline Site Initiation activities, share and harmonise set-up activities evaluation at 6 and 12 months B: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies 75% n/a Industry team work with sponsors and site teams to encourage commercial research to be submitted as NIHR portfolio studies interaction via Principal Investigator (PI), study teams, R&D departments and direct with companies to intervene at the earliest possible opportunity and promote the NIHR portfolio See also MedTech initiative as mentioned above in 3A Ongoing reactive to opportunities Training given to PI and study teams about the merits of portfolio research to allow for early identification of these additional opportunities PO level training via existing research meeting and attendance at SG meetings 4 Reduce the time taken for eligible studies to achieve NHS Permission through CSP Proportion of eligible studies obtaining all NHS Permissions within 40 calendar days (from receipt of a valid complete application by NIHR CRN) 80% n/a Production of weekly report from local Study Management System database for CRN NENC CI-led studies to ensure that 15 day performance indicator target is on track. Performance reviewed by NENC Study Support Team. In conjunction, production of weekly report regarding local PO performance to grant NHS permission to assess for potential delays or blocks and utilising this information, the Research Operations Manager to liaise with PO R&D managers regarding any local processes that may be affecting the timely permission process Weekly review All PO R&D managers to review local SOP re granting NHS permission to reflect forthcoming HRA approval. Interim office processes or addendums to existing office processes or SOPs will be introduced with the intention of introducing a collaborative SOP across NENC Monthly feedback reports Utilising the above 2 actions we would strive to maintain the target of 80% by year end Monthly review 5 Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies A: Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites 80% 80% Monitor Site opening/ Site Initiation date and first consent date of research studies on a local study basis. Collate local intelligence on adherence to recruitment within 30 days of opening and support local teams to achieve this within the first month of opening studies. Monthly feedback minimum from site teams Share any dates with national industry team via RAG study update notes process or on an ad hoc basis with industry national Co-ordinating Centre. Monthly Highlight any First European or First Global patients as soon as in receipt of this information As received B: Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 80% Monthly production of dashboard LCRN report (RAG rated) and utilising this information, the Research Operations Manager to liaise with PO R&D managers regarding any local processes that may be affecting effective first patient recruited. Develop clear lines of responsibilities through close collaborative working with Newcastle University Clinical Trials Unit to identify and resolve issues relating to Red rated studies Monthly reports Monthly exception reporting from PO R&D managers to Research Operations Manager to include reasons for not achieving 30 day recruitment target (this would be the same choice of reasons as for the NHS 70 day benchmark) Monthly feedback returns Utilising the information gained from the above 2 interventions, work with local teams to support the achievement of this target of 80% by year end Monthly 6 Increase NHS participation in NIHR CRN Portfolio Studies A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 99% 99% All of our POs are research active and have reported activity in each quarter in , therefore this is business as usual supported through RDMs and CRSLs Ongoing B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 70% 70% Monitor proportion using data from RAG reports and ODP to ensure that PO coverage remains greater than 70% (currently at 100%) Quarterly See Operating Framework Clause 5.28

5 Objective Measure CRN Target LCRN Goal Specific key local activities for Timescale Industry team to work consistently across all POs to ensure that commercial research activity is promoted in all POs Flag significant risk areas for reduction of commercial activity at PO level. Discussed between Industry Operations Manager (IOM) and Industry Manager as part of their monthly RAG feedback sessions and escalate as necessary Monthly C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 25% 25% 46% of our General Medical Practices (GMPs) have recruited in (as at 20/02/15), and all 13 of our CCGs have more than one active practice, therefore to some extent this will continue to be business as usual. However this is not a consistent spread across all 13 CCGs (26-80% GMPs active), and recruitment in active practices ranges from 1 (a large number of Practices ~80 have only recruited a single participant) to 258. The Research Site Initiative scheme is being redesigned and replaced with the Research Delivery Programme locally to provide more appropriate support to GMPs and be more responsive to those practices with the greatest potential for consistent delivery. We will continue to actively monitor performance in this new scheme Ongoing Through the (already identified) CCG research leads/champions we will identify min. 1 GP to be mapped to each Clinical Research Specialty Group, to act as the information conduit/link across Primary care to facilitate GMPs recruiting to studies across all Specialties End Q1 7 Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio 13,500 1,200 Promote and maximise use of Join Dementia Research (JDR) to identify participants for DeNDRoN studies Explore possibility of Continuous Improvement project across POs to enable easier access and cross-working to access records in response to JDR participants being identified as possible recruits to DeNDRoN portfolio studies Link into LCRN PPI and Comms cross-cutting teams to promote JDR across the network at all opportunities throughout the year Ongoing Work closely with named Research Leads to support feasibility, ensure a rich and balanced portfolio and region-wide engagement with POs and clinical teams to prioritise dementia research Working at a pre-application/pre-approval stage with local Chief Investigators to promote the use of JDR and assist with wording for ethics submission. Ensure new studies are uploaded into JDR and search criteria are set to maximise effective recruitment. Promotion of JDR as a feasibility tool to CIs to gather intelligence on dementia populations providing more accurate feasibility To link into JDR at a national level to maximise recruitment opportunities for our region Enable Team Leaders to provide professional leadership to DeNDRoN delivery staff by ensuring time available to do this and to link into national Senior Leader groups. By ensuring sufficient resource is available to increase access to dementia research for people living in care homes the LCRN will aim to increase research capacity and increase its contribution to HLO7 Ongoing Explore the possibility of a pilot scheme in Northumbria to establish Nursing Home Matrons as ENRICH champions. This will be timed to complement a locally led study in this geographical area and will be hand in hand in enrolling the care homes into the ENRICH programme. Capitalise on the Government s priority for dementia by working into cross-cutting themes of PPI and communications to promote dementia research throughout the LCRN geography at all opportunities and via the LCRN newsletter and website as well as Ongoing Maximise use of feasibility tools as a possible mechanism of identifying patients in primary care who would be eligible for DeNDRoN portfolio studies The proposed local goals for HLO7 have been informed by our local recruitment goals for the Dementias and neurodegeneration specialty. DeNDRoN CRSL and Team Leader reviewed local intelligence of the Portfolio of open and pipeline studies and this informed estimated recruitment goals Network divisional leadership team consulted POs and gathered intelligence on their estimated recruitment goals for the DeNDRoN specialty RDM reviewed all information with CRSL and agreed a local goal of 1200 which is also an appropriate share of the national target of 13,500 participants into the DeNDRoN Portfolio

6

7 CRN: [North East and North Cumbria] Annual Plan Table 2. LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty Objectives 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 1.2 Children All relevant sites that provide services to children are involved in research 1.3 Critical Care Increase intensive care units participation in NIHR CRN Portfolio studies 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) Proportion of NHS Trusts recruiting into Children s studies on the NIHR CRN portfolio Proportion of intensive care units recruiting into studies on the NIHR CRN Portfolio 15 A local Network strategy for Cancer was written in 2014 which identify priorities over three years. The Clinical Research Lead (CRL), Research Delivery Manager (RDM) and Clinical Research Specialty Leads (CRSLs) will develop an action plan to take these priorities forward eg to increase the number of studies for lung cancer Having appointed subspecialty Leads we will formalise contact with them (see 3.1) To work with those successful in receiving network support through the Greenshoots scheme (small awards made to emerging researchers, not previously in receipt of Network funding with the aim of developing them to become PIs). This will expand cancer activity in Northumbria Healthcare NHS FT (NHCT), neuroradiology, urology surgery and early phase studies The CRL/CRSL and RDM attend Network Site Specific Group (NSSG) meetings to discuss research. A research bulletin and list trials will be provided to NSSGs and multi-disciplinary teams (MDTs) Progress towards identified actions in the plan will be reviewed by the leadership team on a quarterly basis 95% Via our local Clinical Research Specialty Group (CRSG) the following actions will be taken during to ensure all relevant sites that provide services to children are research active: Currently some smaller acute NHS Trusts have no activity linked to the Children s Specialty. We have identified a number of Clinicians within many of these Partner Organisations (POs) who we will engage with, in conjunction with Trust R&D teams, to ensure appropriate studies are identified and setup We will identify flexible resource to support activity where there is limited access to research delivery staff A consistent process for managing Expressions of Interest (EOIs) within the Network has now been established for non-commercial studies. This will ensure equity of access and support is available to appropriate studies There are a number of other POs, such as the Mental Health Trusts and Primary Care, which provide children s services and already recruit children into Portfolio studies. However, this activity is reported under a different specialty and we will work with these POs to acknowledge and support this activity at a local level. We will also identify Children s Specialty Portfolio studies which could be delivered within these organisations Identify activity attributed to other clinical specialties which involve children (e.g. diabetes, genetics, neurology) and ensure that this acknowledged at a local level Support Chief Investigators from within local POs and where possible ensure local collaborations are established to maximise the potential recruitment within the Network. 80% In all acute Trusts recruited into a critical care study and we would expect this to continue in By their nature some studies are not suitable for smaller units but we will continue to ensure all acute trusts have the opportunity to express interest and work with POs to ensure capacity and resource to support 1.4 Dermatology Increase NHS participation in Dermatology studies on the NIHR CRN Portfolio Number of sites recruiting into Dermatology studies 150 Recruitment from 7 (of 9) acute Trusts within the Network is targeted through hub and spoke model with hubs at Newcastle upon Tyne Hospitals NHS FT (NuTH), County Durham and Darlington NHS FT 7

8 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) (CDDFT) and South Tees Hospitals NHS FT (STees). In addition, recruitment from minimum of one AQP/GP Practice per CCG (13) Opportunities to develop research activity within Cumbria supported through cross-specialty network nurse resource is being explored. Additional support via increased in consultant sessional support in North Cumbria University Hospitals (NCUH) will also be explored A Dermatology Research Nurses forum is being supported for sharing of good practice and opportunity as well as attention to patient burden on groups of studies often introduced together. 1.5 Ear, Nose and Throat (ENT) Increase NHS participation in Ear, Nose and Throat studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into ENT studies on the NIHR CRN Portfolio 40% In , 4 of 5 Trusts providing ENT services in the Network recruited to ENT studies The 5 th Trust has made a recent appoint of a new Consultant with a keen interest in ENT research, therefore we envisage that all acute Trusts providing ENT services will be able to recruit 1.6 Gastroenterology Increase NHS participation in Gastroenterology studies on the NIHR CRN Portfolio 1.7 Haematology Increase NHS participation in Haematology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Gastroenterology studies on the NIHR CRN Portfolio Proportion of eligible NHS Trusts undertaking Haematology studies in each LCRN 90% In all acute Trusts recruited into a Gastroenterology study Each Trust has a nominated Gastroenterology lead with an agreed local action plan for We are working with low recruiting POs to support existing PI's and one PO has accessed support from another We will continue to support cross-working as capacity demands - our newly established Nursing group within the CRSG will also support less experienced nurses and provide support and advice to the newer teams 50% We are already achieving this target within NHS Trusts which provide haematology services but will continue to work towards engaging more sites in haematology research in anticipation of a more challenging goal next year 1.8 Injuries and Emergencies Increase NHS major trauma centres participation in NIHR CRN Portfolio studies Proportion of NHS major trauma centres recruiting into NIHR CRN Portfolio studies 100% Our two major Trauma centres (NuTH and STees) both recruit into I&E studies Both centres have good links with the North East Ambulance Service (NEAS) and we keen to work with all 3 institutions to further develop their respective portfolios 1.9 Injuries and Emergencies Increase NHS emergency departments participation in NIHR CRN Portfolio studies Proportion of NHS emergency departments recruiting into NIHR CRN Portfolio studies 30% In 2014/15 all emergency departments within our Trusts recruited into NIHR CRN Portfolio studies and we expect to maintain that level in A new large emergency centre is due to open in NHCT and we are hoping to develop a research portfolio there We will continue to ensure all Trusts with an emergency department have an opportunity to express interest and work with PO s to ensure capacity and resource to support 1.10 Musculoskeletal Increase NHS participation in Musculoskeletal studies on the NIHR CRN Portfolio 1.11 Ophthalmology Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Number of sites recruiting into Musculoskeletal studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Ophthalmology studies on the NIHR CRN Portfolio 300 Recruitment will be targeted in all 9 acute NHS Trusts and at least one General Medical practice per CCG (13) Primary care recruitment is being promoted and driven by securing specialist interest GP and community physiotherapist representation on to the CRSG Plan to include developing activity NCUH with selected entry-level studies and also for North Tees and Hartlepool NHS FT (NTH) and STees collaborative musculoskeletal research delivery to be supported A Rheumatology co-lead has been appointed to work with MSK CRSL to engage all regional consultants in the Group and spread the opportunity of NuTH led studies region-wide where feasible 60% In all 5 of our Trusts providing Ophthalmology services recruited to Portfolio studies We will continue to ensure that all of these POs have an opportunity to express interest and work with them to ensure appropriate capacity and resource are available We are also keen to work with Optometrists in Primary care and will explore this as an area for expansion in

9 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) We hope to establish an Ophthalmology Trainee network similar to Intensive Care and Anaesthesia Audit and Research Network North East Trainees (INCARNNET) INCARNNET (Anaesthesia) At Sunderland Eye Infirmary (part of City Hospitals Sunderland NHS FT), trainee participation is actively encourage with 4 out of 6 trainees currently actively participating in study recruitment Participation of trainee doctors in these clinical trials has not only improved their understanding of ethical research but promoted development of essential skills for best medical practice and ignited their enthusiasm for future research As a network we are keen to emulate this trainee involvement in all of our active Trusts 1.12 Renal Disorders Increase the proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which actively engage renal and urological patients in research 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 recruiting into Renal Disorders studies on the NIHR CRN Portfolio which implement Patient Carer & Public Involvement and Engagement (PCPIE) strategies for Renal Disorders research Proportion of NHS Trusts, providing acute Stroke care, recruiting participants into Stroke studies on the NIHR CRN Portfolio 25% The renal research group at NuTH produces regular newsletters for patients. These will continue to be developed in collaboration with Tyneside Kidney Patients Association who, in the future, will circulate the newsletters with their regular bulletins In this will be supported by the CRN Communications Team to develop this further so other contributing renal units benefit Tyneside Kidney Patients Association will be invited to attend SG meetings The CRSL lead is co-lead on the national Specialty Group for communication and has been involved in the development of the Renal Disorders website. 80% All Trusts providing acute care are recruiting into NIHR CRN Stroke studies and we expect to maintain this activity in Surgery Increase NHS participation in Surgery studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting patients into Surgery studies on the NIHR CRN Portfolio 85% In , 8 of our 9 acute Trusts recruited to Surgery studies. The one remaining Trust has recruited well to a study jointly supported by Surgery In we expect all acute Trusts to recruit to a surgery study We will continue to ensure all trusts have an opportunity to express interest and work with PO s to ensure appropriate capacity and resource are available GROUP 2: PORTFOLIO BALANCE Delivering a balanced portfolio (across and within Specialties) that meets the needs of the local population and takes into account national Specialty priorities ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 2.1 Ageing Increase access for patients to Ageing studies on the NIHR CRN Portfolio Proportion of Ageing-led studies which are multicentre studies 50% This target has already been exceeded locally, with 4 multi-centre studies open within the Network 2 new multicentre studies led or co-led from the Network will open in the coming year: 1. Health Services and Delivery research funded Acute Hospital Care for Older People. 2. EME funded LACE trial, ACE inhibitor and leucine in sarcopenia For other recently funded Ageing trials, NENC has been identified as a site including: 3. BICARB Trial (renal) a multicentre trial to be opened in NENC, led by Ageing Many more studies are supported by Ageing and through engagement with ENRICH programme, it is envisaged that this number will increase GP membership on the CRSG is also designed to enable rapid feasibility of primary care as a recruitment setting for new studies.

10 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 2.2 Cancer Increase the number of cancer patients participating in studies, to support the national target of 20% cancer incidence 2.3 Cancer Increase the number of cancer patients participating in interventional trials, to support the national target of 7.5% cancer incidence 2.4 Cancer Deliver a Portfolio of studies including challenging trials in support of national priorities Number of LCRNs recruiting at or above the national target of 20%, or with an increase compared with Number of LCRNs recruiting at or above the national target of 7.5%, or with an increase compared with Number of LCRNs recruiting into studies in: Cancer Surgery Radiotherapy Rare cancers (cancers with incidence <6/100,000/year) Children's Cancer & Leukaemia and Teenagers & Young Adults 15 Implementation of sub Specialty Lead action plan within each tumour area to increase recruitment to open trials Active portfolio management to highlight poor recruitment and engage with PIs Explore opportunities with PIs and local CIs for development of locallyled portfolio studies Regular information updates to site specific MDTs, Strategic Clinical Networks and NSSGs about open studies to ensure network wide recruitment. 15 Implementation of sub Specialty Lead action plan within each tumour area to increase recruitment to open trials Active portfolio management to highlight poor recruitment and engage with PIs Regular information updates to site specific MDTs, CNSs and NSSGs about open studies to ensure network wide recruitment. 15 We intend to maintain our current broad portfolio, which already includes Cancer Surgery studies, and ensure active recruitment in each area through contact with PIs. In particular; Radiotherapy - CRSL has been appointed for radiotherapy research within the Network. Each site has a radiotherapy lead that will be responsible for a portfolio of studies at their site, promotion of research at MDTs and supporting registrar involvement (identification of registrar champions for radiotherapy trials with the aim of improving recruitment). Children s Cancer & Leukaemia a Northern Network is establishing for children and young people with Cancer which will serve the North East and Cumbria, Scotland and North Ireland. This will offer a network approach to trials opening within this geography. By covering a larger population it will be feasible to open studies for patients with rare cancers. The aim will be to double the number of early phase studies across the spectrum of disease areas. Teenagers & Young Adults (TYA) working with the TYA Lead, MDTs, NSSGs and Children and Young People Co-ordinating Group to develop and implement strategies to improve recruitment of patients within this age group 2.5 Cardiovascular Disease Increase access for patients to Cardiovascular Disease studies on the NIHR CRN Portfolio Number of LCRNs recruiting into multi-centre studies in at least five of the six Cardiovascular Disease subspecialties 15 The Network already contributes to studies across all of the sub- Specialties in 10 of the 14 POs in the geography (only the 3 Mental H Health and Ambulance Trusts have not recruited to these studies) We have appointed a senior nurse (theme) lead with responsibility for overseeing the delivery of multicentre studies across the CRN. The combination of this appointment and the fact that the delivery workforce has been maintained means that the expectation is that all POs will recruit in and this target will be met 2.6 Diabetes Increase support for areas of Diabetes research where traditionally it has been difficult to recruit Number of LCRNs recruiting into diabetic foot studies on the NIHR CRN Portfolio 15 There are currently 3 sites recruiting into diabetic foot studies in the Network and we are looking to expand involvement to at least one other PO 2.7 Diabetes Increase access for people with Type 1 Diabetes to participate in Diabetes studies on the NIHR CRN Portfolio early after their diagnosis 2.8 Gastroenterology Increase the proportion of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio 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 Number of participants (per 100,000 population), recruited into Gastroenterology studies on the NIHR CRN Portfolio 15 The CRN has an existing designated nurse supporting ADDRESS 2 that recruits newly diagnosed T1 diabetic patients into a registry for future studies In the last 12 months 20 patients have been recruited into ADDRESS 2 - we will continue to support this study as it is the main tool for identifying patients diagnosed with T1DM and approaching them for other interventional trials within the 6 month window. 15 In , we are confident that we will increase the number of participants recruited into Gastroenterology Studies from our current level of 10 per 100,000 Each acute Trust has a nominated Gastroenterology lead with an agreed local action plans for

11 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) A locally-led study Adenoma recently opened across a number of sites in our Network, which is expected to yield large recruitment numbers The CRSG are leading on an Industry GI Collaborative which will enable us to pool patient resource across the network, enabling all patients the opportunity of accessing commercial studies as well as the more complex early phase 1&2 studies run within the network 2.9 Genetics Increase access for patients with rare diseases to participate in Genetics studies on the NIHR CRN Portfolio 2.10 Haematology Increase access for patients to Haematology studies undertaken by each LCRN 2.11 Hepatology Increase access for patients to Hepatology studies on the NIHR CRN Portfolio Number of LCRNs recruiting into multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium Number of LCRNs recruiting into studies in at least three of the four following Haematology subspecialties : Haemoglobinopathy, Thrombosis, Bleeding disorders, Transfusion 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) 14 We already recruit to multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium and this will continue throughout We currently recruit to thrombosis and bleeding disorders studies within the Network Due to the low prevalence of haemoglobinopathies (e.g. sickle cell disease, thalassaemia) within the demographic of our catchment population it is unlikely that a study in this clinical area would be feasible We will therefore focus on maximising engagement with Portfolio studies in transfusion- at least one such study is due to open in NUTH during In , 7 of our 9 acute Trusts in the Network recruited to Hepatology studies and we are recruiting to studies in all major Hepatology disease areas We are working closely with all our acute Trusts and have agreed leads in each Trust keen to take forward and develop their own local portfolios We will continue to ensure all acute Trusts have an opportunity to express interest and work with PO s to ensure appropriate capacity and resource are available 2.12 Infectious Diseases and Microbiology Increase access for patients to Infectious Diseases and Microbiology studies on the NIHR CRN Portfolio Number of LCRNs recruiting into antimicrobial resistance research studies on the NIHR CRN Portfolio 15 In , 5 of our 9 acute Trusts recruited to Infectious Diseases (ID) and Microbiology studies The 3 main ID centres (NuTH, NHCT, STees) are now collaborating as a group to review and ensure as a region we are coordinating relevant trials We will work with all Trusts for microbiology studies to ensure they have the opportunity to express interest and that there is appropriate capacity and resource In we also plan to develop the Genital Urinary medicine (GUM) ID portfolio and will work with interested PIs s within Trusts and across primary care to do this 2.13 Metabolic and Endocrine Disorders Increase access for patients with rare diseases to participate in Metabolic and Endocrine Disorders studies on the NIHR CRN Portfolio Number of LCRNs recruiting into established studies of rare diseases in Metabolic and Endocrine Disorders on the NIHR CRN Portfolio 15 Through regional meetings, s and personal contact from CRSL we continue to interact with endocrinologists across the Network so they are aware of research activities in rare diseases Ensure local PIs have support in obtaining approvals by increasing access to CRN Study Support team In our local target is to increase the number of POs recruiting to M & E studies 2.14 Oral and Dental Increase access for patients and practitioners to Oral and Dental studies on the NIHR CRN Portfolio A: Proportion of Oral and Dental studies on the NIHR CRN Portfolio recruiting from a primary care setting 20% Primary Care Dental Research Forum CPD event for GDPs across the region is planned for June 2015 and an appropriately tailored form of Research Site Initiative (RSI) scheme to be introduced for community dentists Pipeline of community based research for dental is currently not evident however with 2 large studies recently complete B Proportion of participants recruited from a primary care setting into Oral and Dental studies on the NIHR CRN Portfolio 30% Subject to available pipeline, a role of dental facilitator will be explored with focus on Primary Care CRSG is exploring the use of NIHR publicity with associated HEI partnerships being used within community settings.

12 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 2.15 Primary care Increase access for patients to NIHR CRN Portfolio studies in a primary care setting 2.16 Renal Disorders Increase NHS participation in Renal Disorders studies on the NIHR CRN Portfolio Proportion of NIHR CRN Portfolio studies delivered in primary care settings A. Proportion of acute NHS Trusts recruiting into multicentre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio B. Proportion of Renal Units recruiting into multi-centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 15% Implementation of feasibility tools across the Network to increase access to primary care populations for all CRSGs Re-design of the RSI scheme to ensure that resource follows activity and opens up all potential primary care sites including e.g. pharmacy Increase the proportion of GPs as members of CRSGs, aiming for full coverage of all Specialties Commissioning Support Unit delivery staff also supported to join Specialty Groups across the Divisions 30% Currently there are 9 RCTs open and recruiting across 5 of our 9 acute Trusts within the Network and therefore we have exceeded (and expect to maintain) this target There is a move locally to expand the Benign Urology portfolio and we envisage that this will open up new opportunities for other POs to contribute The commercial pipeline is healthy and the target is to open up at least one further PO to commercial recruitment during % 100% of Renal Units within our Network (4 of 4) are recruiting into m/c RCTs, our expectation is that this will continue 2.17 Respiratory Disorders Increase access for patients to Respiratory Disorders studies on the NIHR CRN Portfolio Number of LCRNs recruiting participants into NIHR CRN Portfolio studies in the Respiratory Disorders main disease areas of Asthma, COPD or Bronchiectasis 15 In , 7 of our 9 acute Trusts in the network recruited to Respiratory studies. We are working with all our Trusts and Primary Care to identify local leads keen to take forward and develop local portfolios inclusive of Asthma, COPD and Bronchiectasis We feel there is significant potential to further develop the Network s Respiratory Portfolio and will continue to ensure all Trusts have an opportunity to express interest and work with PO s to ensure appropriate capacity and resource are available to support 2.18 Stroke Increase the proportion of patients recruited into Stroke randomised controlled trials on the NIHR CRN Portfolio Number of patients (per 100,000 population) recruited into Stroke randomised controlled trials on the NIHR CRN Portfolio 8 This level is already exceeded, with the Network currently recruiting 20 patients per 100, 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 B: Number of patients recruited to complex Hyperacute Stroke studies on the NIHR CRN Portfolio in each NIHR CRN HSRC 50 Review of the patient pathways leading to rapid transfer within the region 15 Reconfiguration of the research support infrastructure and MRI availability at the Royal Victoria Infirmary (Newcastle upon Tyne Hospitals NHS FT) as host for the HSRC GROUP 3: RESEARCH INFRASTRUCTURE Developing research infrastructure (including staff capacity) in the NHS to support clinical research ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 3.1 Cancer Establish local clinical leadership and a defined portfolio across the cancer subspecialty areas Number of LCRNs with, for each of the 13 Cancer subspecialties, a named lead and a defined portfolio of available studies 15 Sub-Specialty Leads have been identified and the leadership team will maintain regular contact with sub-specialty Leads with two monthly updates from each including feedback from national meetings 3.2 Anaesthesia, Perioperative Establish links with the Royal College of Anaesthetists Specialist Registrar networks to support recruitment into Number of LCRNs where Specialist Registrar networks are recruiting into NIHR CRN Portfolio studies 4 We are actively engaged with the trainee network Dr Ed Pugh is chair of the local trainee network (INCARNNET) and is a member of our CRSG

13 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) Medicine and Pain Management NIHR CRN Portfolio studies Dr Mark Callaghan appointed as in-programme research fellow for 6 months in February 2015 and will have 1 day per week to develop INCARNET; he will also be leading on POPULAR an observational portfolio study We are encouraging the trainee network to apply for a small research grant in Spring 2015 supported by consultant members of the CRSG 3.3 Dementias and Neurodegeneration (DeNDRoN) Optimise the use of Join Dementia Research to support recruitment into DeNDRoN studies on the NIHR CRN Portfolio The proportion of people identified for DeNDRoN studies on the NIHR CRN Portfolio via Join Dementia Research 3% Maintain delivery staff training (currently >70% trained) & support to enable access and use of JDR. Continue links & promotion of JDR through memory clinic research champions Continue to support our JDR Champion in promoting public awareness of JDR Ongoing promotion to clinical teams in POs to raise awareness of JDR Ongoing involvement in national monthly teleconferences Ensuring use of JDR where appropriate in all recruitment strategies Promote JDR success stories in LCRN newsletter Link to JDR on Network supported PPIE website: Dementias and Neurodegeneration (DeNDRoN) 3.5 Infectious Diseases and Microbiology Increase the global and psychometric rating skills and capacity of LCRN staff supporting DeNDRoN studies on the NIHR CRN Portfolio Maintain research preparedness to respond to an urgent public health outbreak 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) Proportion of LCRN staff who support DeNDRoN studies who have successfully completed Rater Programme Induction and joined the national Rater database Number of LCRNs maintaining a named Public Health Champion Number of staff trained in frequently used Mental Health study eligibility assessments 40% 50% of staff who support DeNDRoN studies have completed the Rater Programme Induction and have joined the national Rater database These levels will be monitored to ensure ongoing compliance with this measure by ensuring new staff have access to training and that all staff have access to Rating opportunities where possible, to maintain skills Resource has been included In the Network s Learning and Development programme to fund attendance at a Train the Trainer session should this become available nationally. The Network will then add the Rater Programme Induction to the Learning and Development programme locally Dr David Chadwick DavidR.Chadwick@stees.nhs.uk The Network has developed and actively promoted an Urgent Health Care Research Delivery Plan To ensure business continuity processes are maintained we will work with POs to ensure essential business processes can be maintained including covering major staff absence, and prioritisation of business activities The NHS Permissions process for expediting sleeping studies is now established and local R&D departments are aware of their role in expediting this, and we are confident they will be able to respond quickly and initiate and report on studies related to the pandemic /outbreak, including EBOLA studies (NB NuTH is a designated EBOLA treatment centre) A network working group has been convened to meet in the case of an urgent public health outbreak. This group will also review the plan and list of studies on an annual basis. The group includes representation from Public Health England 9 out of 14 staff members supporting MH studies are trained and have used PANSS eligibility assessments. Staff members supporting MH studies have had training and opportunity to use other frequently used MH study eligibility assessments eg AIMS, CGI-S, EQ-5D, ASCQ, CDSS Ian MacMillan, Consultant Psychiatrist and local PI has been identified as a trainer for the national CRN: Mental Health PANSS Training program. We will identify a local training facilitator to participate in the Train the Trainer programme and deliver PANSS training locally thereafter. We will monitor staff skills and capacity to maintain and enhance current levels of expertise.

14 ID Specialty Objective Measure Target LCRN activities and initiatives to contribute to achievement of objective(s) 3.7 Neurological Disorders Increase clinical leadership capacity and engagement in each of the main disease areas in the Neurological Disorders (MS; Epilepsy and Infections) Specialty Number of LCRNs with named local clinical leads in MS; Epilepsy and Infections 15 MS Lead Dr Joe Guadagno Epilepsy Lead } We do not yet have identified leads for these areas Infections Lead} and will work to identify them in year 3.8 Reproductive Health and Childbirth Increase engagement and awareness of the Reproductive Health and Childbirth Specialty Number of LCRNs with a named midwifery lead to increase engagement and awareness 15 Network Midwife Champion appointed Fiona Yelnoorkar, and attendance at national meetings will continue to be supported Process underway to identify RH&C Nurse Champion to work with the Midwife Champion to ensure awareness and engagement across the entire RH&C portfolio Local Nurse/Midwife research forum held quarterly to aid engagement, sharing best practice and personal and professional development.

15 CRN: [North East and North Cumbria] Annual Plan Table 3. LCRN plans against the Operating Framework POF Area Operating Framework requirement Operating Framework Reference LCRN Governance Research Delivery The Host organisation shall develop and maintain an assurance framework including a risk management system 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. 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. The Host organisation must ensure that LCRN activity is included in the local internal audit programme of work The Host organisation shall ensure that all LCRN organisations adhere to national systems, Standard Operating Procedures and operating manuals in respect of research delivery as specified by the national CRN Coordinating Centre. The Host organisation shall ensure that the Information required 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 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 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 Confirm name and contact details of LCRN s Public Health Champion against Specialty objective Date of planned audit or anticipated timescale if exact date not yet known 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 Planned LCRN actions/activities for or other requested information Milestones & outcomes once complete Timescale Existing plan to be activated upon request As per plan Not known Provided via completion of Table 2 Scheduled for Q audit report received 23 December Management response provided March Sharon Dorgan, Research Operations Manager is the assigned link person for the LCRN and is a member of the national Study Support Service links working group and has already participated in the first national meeting. Information on the service has been cascaded through a variety of routes: to R&D managers via regional LCRN chaired research meetings, to the LCRN Operational Management Group, to the LCRN Executive and information will be shared with the wider research community via a Link person in place Meeting dates & venues have been set and details circulated for 2015 Q3 01/12/ /01/2015 on-going 15

16 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. Provide a brief outline (1-2 paragraphs) of the LCRN s plans for implementation and delivery of the Study Support Service poster presentation at a NENC network event to be held in February A rebranding exercise, to incorporate the terminology of Study Support Service has already taken place within the LCRN. This term is now used to describe the personnel that were formally known as the core RM&G team, alongside those of the Research Study Coordinating team. This amalgamated team now has established weekly teleconference meetings and monthly face to face meetings to review progress of studies along the research pathway. The central inboxes of the former 2 teams have also been amalgamated into one and comprise the term study support within the address. On-going management & development Central point of contact established for the service 01/01/2015 on-going 01/01/2015 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 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) guidance 1 and a description of the model(s) the LCRN has used to date in providing advice 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 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 performance 2. The next plan for the service is to include a review of new potential models of working whilst remaining a cross-cutting theme. A survey to assess NENC chief investigators support requirements is also being prepared as well as piloting the benefits of a Chief Investigator support champion across the LCRN. CRN NENC has an AcoRD Specialist and training to support implementation of AcoRD was initially offered to R&D managers back in The RDS, AcoRD Specialist, R&D Managers and their finance teams in all POs can be contacted for advice on the attribution of activities. This model will continue alongside the local development of the study support service The LCRN Study Support Team will continue to provide central study wide governance support until this function is transferred across to the HRA during In the meantime processes are under continuous review to identify any areas for smarter working practices and removal of duplication of effort. Research Operations Manager to actively engage in planned NIHR workshops regarding HRA readiness plans. A series of LCRN led teaching sessions regarding the CSP amendments process are being delivered to support local understanding. Should network funded CSP governance related posts become vacant, the LCRN and POs are in discussion as to how best manage such vacancies and to review appropriate revision of job descriptions to reflect the change in emphasis from governance to delivery moving forward. There is a region wide industry team who are accessed via the single point of contact and working under the IOM to deliver a robust and consistent feasibility and performance management process throughout the POs and across divisions. Clear indication of support requirements so that the service can be tailored accordingly Effective and responsive service available to Chief Investigators wherever they intersect with the LCRN On-going management & support NIHR led workshops and working with other RMG national Leads. On-going engagement with R&D managers Full cross Divisional and PO coverage in place Survey to be circulated 02/15. Review of CI service July 2015 Ongoing Monthly review during 2015 to assess progress of HRA plans 02/ /2015 Monthly 01/11/ Available from: 2 Information on recent performance provided by national CRN Coordinating Centre on 30/01/15

17 cross-divisional Industry function, including the single point of contact service, within the LCRN. The Industry Operations Manager will work closely with each Divisional Research Delivery Manager across all research divisions to ensure consistency of feasibility, study delivery and coordination across all divisions within the LCRN. The Industry Operations Manager will be responsible for the promotion of the Industry agenda to LCRN Partner organisations and investigators, delivering aspects of a national NIHR CRN Industry Strategy within the LCRN. Feasibility is issued and collated by the industry team in collaboration with the site study teams/ research nurses, potential Principal Investigators (PIs) and Trust R&D Managers or teams. Historical performance information is kept on the industry active PIs and used to populate both site identification and site intelligence. Information is also kept on Trust support systems by the nominated industry team member to complete the forms. Every endeavour is made to adhere to timelines for submission of Site Identification and Site Intelligence and if there are any delays then this is communicated with the CC team to ensure that they are aware of likely late returns and the reasons to communicate to the sponsor. Local data is monitored not only on successful delivery of time to target and FPFV, but also on trends in EOI outcome (% submitted versus % won by the site) the intention is that this will show areas of strength and necessary improvement requirements for the industry team to work on. Feasibility process pathway developed for Divisions 2, 3, 5 and 6. In progress for Divisions 4 and 1 LPMS system to enhance this currently interim Study Management System in place 01/04/ /04/2015 ongoing Recruitment to time and target, and overall industry study performance is monitored via a localised version of the national industry monthly RAG reports, which are disseminated on a Divisional, Specialty Group and PO basis. These reports include both national data and also local performance data which is amended by POs and fed back to the national industry team via the Industry Study Update Notes on a monthly basis. Amendments include identifying studies missing from the open portfolio, updating dates and targets. Local RAG reports available monthly +2 weeks from National report release or less Monthly When a study is Red for one month or more a local action plan is devised to clarify the nature of the recruitment issue (if there is one) and plan to rectify it. The RAG reports are discussed on a monthly basis on a one-to-one meeting with the IOM by each of the Industry team and escalated where necessary to the region wide industry team meeting for discussion across the team as a whole (where issues are not limited to a single site in the region), escalated to the IOM or Industry Clinical Lead for action, or to the RDM. Local Escalation plan process in place from 2014 formalise in writing after evaluation 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 Trends and repetitive issues are noted and examined and this information is used to inform the ongoing feasibility process for teams in the future. The local industry team takes part in national teleconferences with Coordinating Centre staff to discuss performance with sponsors/ CROs and feeds back written information/ escalates into the national team where appropriate as well. Baseline Status The NIHR CRN costing template is the sole mechanism for negotiating industry costs in all POs across the Network - the process has been wholly adopted by all organisations in this area. Strategic analysis of EOI performance and RTT performance process to be in place and monitored Complete July 2014 ongoing management and development Review by 31/03/2015 ongoing monthly thereafter 31/07/2014 Strategic Development There is a region-wide, industry team led Finance Management Group which is continuing to develop strategies for income distribution and management of industry income within the region. This has a membership of representatives of the LCRN Industry team, Continuous Improvement Lead Capacity building spend strategy agreed by Executive and Partnership Group by 08/01/2015 Launch 01/04/2015 yearly return

18 Delivering on the Government Research Priority of Dementia Patient and Public Involvement and Engagement (PPIE) Continuous Improvement (CI) 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 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. 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. The Host organisation will promote and sustain a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance 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 Provide the name and contact details for the senior leader with identified responsibility for patient and public involvement and engagement Provide an assessment of the LCRN s current position in relation to Continuous Improvement and Research Management team and also all POs (R&D Manager, R&D Director or Finance Manager). This group has been working on mechanisms to demonstrate the usage of Capacity Building element of industry costs, and also in development is a region wide joint costing process (using the NIHR costing template) for studies which have more than one site within the NENC region. Future topics include standard contracts (when the mcta has been altered but has been legally reviewed and accepted by one or more organisation in the region for a particular sponsor) and invoicing processes. Dementias: Dr Andrew Byrne Andrew.byrne@ntw.nhs.uk Parkinson s disease: Dr Richard Walker Richard.walker@nhct.nhs.uk Huntington s disease: Dr Suresh Komati Suresh.komati@ntw.nhs.uk Motor neurone disease: Dr Tim Williams Tim.williams@nuth.nhs.uk Provide via completion of Table 4 Hilary Allan Research Delivery Manager/functional lead for PPIE Hilary.allan@nhs.net Chris Elliott PPI Manager Christine.elliott@newcastle.ac..uk Continuous improvement (CI) is integral to all that we do in the Network, with significant buy-in across all levels of staff in the central team and transformation being a high priority across the NHS organisations in the North East and North Cumbria. The CI Working Group meets quarterly to discuss CI initiatives and allocate tasks for members to undertake. The Group is composed of the following members: CI Lead Industry representative RDM PPI representative Communications representative 4 PO representatives (R&D and delivery) Region wide costing being developed from 12/02/2015. Informal pilot in place from then onwards. Formal pathway to be agreed Invoice process in development Launch 01/10/2015

19 There are two areas of work within CI: Improving performance and measurement This looks to identify the appropriate metrics to monitor and show performance towards our objectives, looking for more sensitive measures of performance and local priority measures. So far, the focus has been on two areas of Network business: industry and PPIE, looking at incentives to improve commercial funding transparency and recycling and research awareness raising activities within POs. The awareness raising includes badges and cardboard cut outs for use by research staff in POs, and work has started on improved website information, accessible to patients, and research wording on clinic letters. Culture change and empowerment This activity utilises Network events to promote CI and start to empower staff at all levels to get involved in improvement projects and creating a CI community, getting suggestions for improvement projects from those at the frontline within POs. This will be backed by training, tapping into the courses already provided by PO lean / transformation teams and running NIHR CRN CI training courses. Two members of staff are currently undertaking the Green Belt training provided by the national Coordinating Centre, looking at ways to visualise the workforce from a job role and task viewpoint, working towards resource scenario planning; plus looking at how to embed and widen the use of the NIHR Hub across all the work we do and improve acceptability of it as a tool to share resources. In February 2015, at the annual Network event Moving from Good to Great, awards were given out for innovative and collaborative ways of working that have impacted on research delivery in the region. In addition to thanking our research workforce for their dedication, this has enabled us to highlight good practice that we can share across the other specialties and trusts, allowed us to find the innovators who go above and beyond to invite into the CI community, and has given us many great stories for use in communications and promotional material. These examples will also be shared nationally through the CI Hub site and with the other CI Leads. 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) We intend to develop incentivisation mechanisms for POs achieving specific CI targets Provide via completion of Table 5

20 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) Provide details of continuous improvement projects to be delivered locally in (via CRN Central) 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 Please submit details by adding to CRN Central 3 Provide via completion of Table 6 Learning and Development Penny Williams Research Delivery Manager/functional lead for Learning and Development Penny.williams2@nhs.net Tom Wooldridge Learning and Development Manager Tom.woodlridge@nhs.net Workforce Intelligence Steve Pratt Research Delivery Manager/functional lead for Workforce Intelligence stevenpratt@nhs.net 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 Confirm LPMS systems are live and operational as required Confirm arrangements are in place for provision of an LCRN Service Desk function and provide contact details Provide the name and contact details of the identified lead for the Business Intelligence function John Rouse Workforce Intelligence Project Manager John.rouse@nhs.net LPMS procured and on track for a mid-may go-live date Provided by the Business Intelligence team tnu-tr.nenc-businessintelligence@nhs.net Justine Smith Continuous Improvement and Business Intelligence Lead Justine.smith3@nhs.net 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 Describe the dedicated communications function the LCRN has in place 14.2 Outline up to 5 priorities/priority activities contained in the LCRN s local communications delivery plan Lestryne Wheldon - Business Intelligence Manager Lestryne.wheldon@nhs.net In the majority of our Communications function was delivered by an external provider to allow us to scope the nature of the function we wanted to develop whilst allowing us to have expert resource available in year 1. A substantive appointment to the role Head of Communications was made in January 2015, but the candidate withdrew at the end of February. We will therefore continue to utilise our external provider whilst we consider the best option for providing this function. This may become our preferred solution. This individual is supported by a Communications Administrator (1.0wte in post) and a content manager (job title to be agreed, moving from another LCRN-funded post 1 April - 0.5wte) These 3 roles will ensure that the communications function is fully staffed and has the skill set required for implementing the communications strategy for the Network. Review and refine key messages for the NIHR CRN:NENC in line with NIHR CRN CC Develop mechanisms for measuring and reporting on communications effectiveness Development of key messages matrix Implementing measures and methods of review. By end of June 2015 By end of September 2015 Develop, build and integrate a Customer Relationship Management (CRM) database for the Network Ownership of and development of a clean, segmented, effective, CRM system used across Network for communicating with audiences By end of September

21 Review, develop and execute communications plans to support Network communications and engagement activities Communications Plan - segmented into Divisions/ Specialties as necessary April/May 2015 ongoing Information Governance Actively promote and enable good information governance relating to all areas of LCRN activity 14.3 Budget line identified in Annual Financial Plan for Provide the Information Governance Toolkit (version 11) 4 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 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 15.8 Provide the name, 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 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 Strategy 5 Identify and link to other networks/organisations communications activity, eg Partner Organisations, AHSN etc Score 87% Reviewed Satisfactory 27/05/14 Please submit as Appendix 2 to your plan LCRN presence on other networks /organisations communications activity By end of March 2016 Lestryne Wheldon, Business Intelligence Manager is the LCRN s initial contact point for IG queries Lestryne.wheldon@nhs.net tel: Richard Oliver is the Host Organisations IG Lead Richard.oliver@nuth.nhs.uk tel: Richard has links with all other IG Leads within our Partner Organisations. Richard and Lestryne will work together to provide this support Procurement of an LPMS (ReDA) to replace SMS (Study Management System) and allow local data to be made available for wider integration into NIHR wide tools. This will enable data to be entered once and reused many times to avoid unnecessary duplication by researchers and research staff Continue rollout of regular ODP training to ensure researchers and LCRN core staff have access to information at any time Production of monthly reports from SMS (Study Management System), Portfolio raw data and ODP to deliver intelligence for planning and management, available on the NIHR Portal (to be replaced by the NIHR Hub) Training/rollout of the NIHR Hub as a replacement to the NIHR Portal as a repository

22 CRN: [North East and North Cumbria] Annual Plan Table 4. LCRN Patient and Public Involvement and Engagement (PPIE) Plan Planned actions in Milestones and outcomes once actions complete Timescale Lead Further develop and embed PPIE lay representative remuneration policy and procedure. Lay membership of governance groups complete and stable (Partnership Group and Executive Group) Consultation with patient groups on experience of accessing reimbursement Share and compare policy and procedure with other parts of the system (Research Design Service, AHSN, Clinical Trials Units), with view to harmonisation All appointments made April 2015 for consultation and take to CRN Executive Board in summer 2015 End April 2015 Hilary Allan (Research Delivery Manager/Function Lead for PPI)/ Chris Elliott (PPI Manager) Hilary Allan (with RDS and Learning and Development) Appropriate training and support accessible including mentoring. To support local development of a region-wide Children s Group Induction programme established with RDS, building on existing materials and liaising with Network Learning and Development team Support region-wide initiative to create Children s Group End June 2015 Monthly updates Chris Elliott Work with Partner Organisations (POs) in developing group and supporting staff. Link nationally with Children s groups and central CRN PPIE team To develop links with and support Youth Speak Develop business case for remunerated PPIE Link in Children s specialty Use to cascade information Support group and create event promoting research engagement through innovative use of media (film night with regional press) Business case approved Clinical Trials week May 2015 Completed by April Exec 2015 Chris Elliott/ Communications team Chris Elliott / Hilary Allan Increase awareness of Ageing research studies in the NENC forging links across our Work with Ageing Specialty across HEIs and PO s to increase awareness of Ageing research Q2 review of progress presented to Exec Chris Elliott / Hilary Allan

23 CRN: [North East and North Cumbria] Annual Plan PO s and with the Centre for Age and Vitality at Newcastle University and emerging National Centre for Ageing Science and Innovation (NASI) Develop business case for remunerated PPIE Link in Ageing specialty Develop PPIE Leadership and Involvement programme with central CRN PPIE team Develop workforce development PPIE programme with CRN central PPIE Links opportunities in local communities. Liaise with division 4 and ENRICH Care home initiative. Business case approved Work with central CRN team to develop PPIE Confidence in leadership training for people interested in championing research in their patient groups and local communities. Pilot regionally (NENC). Work with central CRN team and nominated local Clinical Theme Leads to develop PPIE training for front-line CRN research staff. Pilot regionally (NENC) Work with Business Intelligence team and PPIE Facilitator (tba) to develop Google platform for PPIE (October 2015). Completed by April Exec 2015 TBC dependent on CRN TBC dependent on CRN 1 May Chris Elliott / Hilary Allan Chris Elliott Chris Elliott Chris Elliott Branding Promotion Influence development of tools to measure patient experience and implement across NENC PPIE Steering Group PPIE Steering Group formed &meeting schedule established including significant training events for all Specialty Group PPIE Links Run training for each PPIE Link to use platform Develop a PPIE local branding strategy in line with CRN branding Pop-up promotions in Trusts, explore possibility of accessing shared RDS support on common remit Implementation plan Survey Analysis Work with RDM s and Specialty Leads to establish PPIE Links Two meetings/training events/networking opportunities Monthly Launch Clinical Trials day (May 2015) Quarterly Governed by national timelines?june?september?december April 2015 June and November PPIE Facilitator (tba) Chris Elliott / Communications team Chris Elliott Chris Elliott with national PCPIE IMPACT Project task force Chris Elliott Chris Elliott /business Intelligence

24 CRN: [North East and North Cumbria] Annual Plan Table 5. LCRN Continuous Improvement Action Plan Planned actions in Milestones and outcomes once actions complete Timescale Lead Raising Research Awareness Minimum R&D website content for Partner Organisations (POs) - Guidance piloted by PO members on the CI Working Group. Minimum standard for research web content guidance document launched across POs Roll out of guidance on research visibility on PO premises and provision of promotional materials Review of PO premises to look for visibility of research activity (awareness raising materials) POs apply to relevant local Trust bodies/committees for adding research statement to clinic letters Review clinic letter research wording initiative with POs and patients and decide on further roll out Review of how patients are approached about research studies and what will empower them to ask about studies Draft guidance used by 2-3 POs represented on the Working Group to provide information on research to patients and the public, feeding back into final guidance. 100% of PO websites having minimum research content, which is accessible to patients and the public Guidance and promotional materials pack available to POs to increase awareness of research activity to patients, the public and non-research staff 100% of PO premises having visible signs of research activity 3 POs to gain approval for 3 specialties to add a research statement to clinic letters Assessment of success of research wording on letters and decision on whether to roll out wider Report showing areas for improvement in approaching patients to take part in research and information on what information patients would like to empower them to ask about research April - May 2015 Justine Smith Continuous Improvement Lead Launch June 2015 Roll-out June-December 2015 review of webpages January 2016 July September 2015 December February 2015 April September 2015 Launch pilots once approvals gained June-October 2015 February 2016 review acceptance by patients and staff, and process for gaining institutional approval March 2016 decision to roll out more widely Review of impact in September 2016 May 2015 Justine Smith Justine Smith Research Delivery Managers Justine Smith Justine Smith Joanne Stephenson Industry Manager

25 CRN: [North East and North Cumbria] Annual Plan Work with POs to promote the role of Patient Champions and assist with recruitment where support required. Direct Access to Research Guidance and policy development on patients directly accessing research studies Commercial Income Documented transparent process for recycling commercial income Reporting capacity build element of commercial income Agreement on acceptance of externally negotiated costs and process of managing the review for any local anomalies Commercial Metrics Collection of additional data items on commercial studies, to review against standard performance measures e.g. no. new PIs, no. studies per PO, no. SGs commercially active, uptake and success of PICs, no. 100% of POs having patient champions for research appointed 100% of POs having a process for managing patients who self-refer for research studies, without being a current patient or via clinical referrals, empowering patients to directly contact organisations running studies into their condition equity of access Written process for recycling commercial income for 100% of POs and Primary Care, demonstrating how commercial income is being used to support a stable research resource in the NHS Provision of reports showing how the capacity build element of commercial income is being utilised and planned areas for growth. This will give a wider view of the portfolio study workforce. One cost negotiation by lead Trust for multicentre commercial studies recruiting across more than one Trust in CRN: North East and North Cumbria. Changes for additional sites should be minimal, only being renegotiated where significant differences in delivery resource or additional services required. Review of metrics available on the commercial study set-up and delivery pathway, to find sensitive indicators of success. The collection of data will provide a baseline from which to pilot Promote role and support POs from April 2015 Posts in place by March 2016 June 2015 guidance launched October 2015 policy launched for local implementation (if required) Hilary Allan Research Delivery Manager (Division 5) Sarah Daniel (R&D Manager, Tees Esk and Wear Valleys NHS Trust) and Justine Smith April 2015 Morag Burton Industry Operations Manager Launch April 2015 Return for year-end by July 2015 Launch October 2015 Review April 2016 Launch proactive collection of new data items from April 2015 Review December 2015 Additional performance goals rolled Morag Burton Morag Burton Morag Burton

26 CRN: [North East and North Cumbria] Annual Plan multisite studies within local Network Collection of data on feasibility success e.g. response rate to Expression of Interest (EOI) requests and conversion rate for EOIs to selected sites monitoring and intervention based on new metrics. The overall aim being to improve performance and informing goal setting for future years. Review of feasibility success, the data providing a baseline to inform goal setting for future years. out April 2016 Launch proactive collection of data items from April 2015 Review data December 2015 Morag Burton Review of success of Gastroenterology Collaborative single delivery offering to companies across more than one site Review success factors of collaborative for roll-out plan into other specialty areas Additional performance goals rolled out from April 2016 Review December 2015 Roll-out plan March 2016 Morag Burton Research Workforce Review of cross-organisation and crossspecialty working in workshops Guidance on supporting a flexible workforce Creation of a matrix to map the workforce/roles and key skills across the CRN Good practice awards nomination request, judging and presentation Gaining an understanding of the positives of flexible working and areas for improvement in managing a flexible workforce Sharing of good practice on how to manage and support flexible workers, including the positives of this working pattern Improved visibility of skills matches for workforce planning in specialties and divisions Information made available and design of tools to allow scenario planning and resource review. Acknowledgement of innovative ways of working and collaboration across stakeholders and boundaries, showcasing and sharing best practice in the region. Provides good practice Launch in other specialties from April 2016 June September 2015 December 2015 Visibility of workforce roles and skills September 2015 Information reported to allow scenario planning and build of tools March 2016 Nominations December 2015 Presentation at annual Network event early 2016 Justine Smith Justine Smith John Rouse Workforce Intelligence Project Manager Justine Smith

27 CRN: [North East and North Cumbria] Annual Plan Online Collaboration Space Hub Continuous Improvement Hub site Training Two trained experts on the application of six sigma in the CRN, to assist and support the management and recording of CI projects Create a facilitator workforce and support network for running CI projects Utilise in-house training programmes to embed CI principles in the research workforce Managing CI Portfolio Create online form for collecting ideas for continuous improvement projects and collection of ongoing projects undertaken within trusts, and publicise in newsletter and via Working Group Prioritisation of projects and allocation to facilitators National Projects Attendance at National CI Lead meetings and support for National CI projects examples for wider roll out and promotion. Review of Sharepoint use and move to the Hub, increasing the ability for collaboration across the CRN Create and maintain a CI work space on the Hub to collect and share information on ongoing projects and provide forms and tools for the Working Group and facilitators locally April May 2015 September 2015 March 2016 September 2015 Creation of database of improvement areas and information to upload onto national database of projects Continual flow of improvement projects and list of priority areas for the following year. Creating and maintaining a national community of CI focused staff to share good practice and work together towards improvement goals affecting all LCRNs and centrally managed functions. Rolling out initiatives agreed by the CI Steering Group. April June 2015 Ongoing monitoring of Hub usage April June 2015 create shared workspace July September create CI community Ongoing review of use Adam Unsworth and John Rouse Justine Smith Justine Smith May - June 2015 Ongoing upload of projects October 2015 March 2016 Ongoing Adam Unsworth Systems Administrator Adam Unsworth and Justine Smith Justine Smith Justine Smith Justine Smith

28 CRN: [North East and North Cumbria] Annual Plan Table 6. LCRN Workforce Plan Planned actions in Milestones and outcomes once actions complete Timescale Lead 6a Learning and Development Plan (LnD) Support a model of learning which integrates national programmes with locally led initiatives eg: regional rollout of new NIHR courses and developing local courses (see below) Strategic overview by Steering Group. Inaugural running of new training from national programme as early as possible after courses are released by NIHR. June 2015 Dependent on release of national programmes Tom Wooldridge Learning and Development Manager Provide agile and responsive training programme for region s research staff Others to be added as/when developed Initial dates/venues for to be completed early Feb to enable booking of places from April. On-going review throughout Tom Wooldridge Develop and deliver Research Delivery Skills training locally via Working Group (multiorganisation/disciplinary representation) On-going review throughout ; training programme to be adjusted according to needs/demands/national & local initiatives. Use feedback from Moving From Good to Great network event workshop (Feb 2015) for further development - May 2015 January 2016 Tom Wooldridge Pilot training Sep 2015 Offered as part of training programme Jan 2015 Localised version/delivery of Working in the CRN to include Dementia Friends awareness and PPIE awareness Share course information with national workforce intelligence team during development WitCRN session to be refined following feedback from local pilot Sessions included in training programme with delivery supported by local facilitators May 2015 Tom Wooldridge Collaborate with Dementia awareness & PPIE colleagues to ensure incorporation of those elements.

29 CRN: [North East and North Cumbria] Annual Plan Table 6. LCRN Workforce Plan Consolidation of facilitator team with assessment, support and development processes. Establish sufficient number of facilitators to enable delivery of programme Regular meetings between LnD Manager and Facilitators Ongoing Tom Wooldridge Refine, implement and evaluate a standardised induction framework Identify opportunities for patients, carers and the public to be involved in the planning and delivery of our learning provision Learning and Development Steering Group provides strategic guidance to LnD function. Co-design and deliver a 2-day introduction to clinical research course for Health Education North East (HENE) Annual assessment for all facilitators Pilot induction framework (specific to role) Roll out of induction framework within the Network Work with local and national PPIE teams Patients, carers and the public involved in delivery of at least one learning and development session. Steering Group, with multi-organisation / disciplinary representation, meets three times per year reporting to CRN: NENC Executive Committee. Course designed - methodological components (delivered by NU), governance and research delivery (delivered by CRN) June 2015 James Pitchford Project Manager March 2016 Penny Williams - (Research Delivery Manager/Function Lead for LnD) March 2016 Design by end Q1 Penny Williams Penny Williams Scope opportunities for developing clinical research training across all Specialty Trainees (STs) in collaboration with HENE. Course to be provided twice per annum Define provision of research training to trainees in all specialties, including curriculum content, skills and competencies as well as specific opportunities to contribute to research in programme. (Understanding the capability and impact of existing bespoke networks established in specialties such as Trauma and Orthopaedics, Ophthalmology and Anaesthetics) will be an important component of this project. Deliver Q2-4 Report by December 2015 Professor Amar Rangan (Clinical Research Lead)

30 CRN: [North East and North Cumbria] Annual Plan Table 6. LCRN Workforce Plan b - Workforce Intelligence Plan Complete review of Workforce Intelligence (WI) survey data, including report Liaise with Partner Organisations (POs) to capture job descriptions (JDs) and actual resource utilised for NIHR CRN Portfolio research Run workshops with staff groups to embed communities of practice (COP) and future collaboration. Run workshops with staff groups to define and develop job role outlines Report disseminated with POs via WI Steering Group Utilise data from survey to inform development of staff workshops. Using data from survey and from JDs to map out commonalities for staff groupings, liaising with national initiatives to ensure consistency of approach Map out actual resource available using data from survey and from POs. In liaison with Business Intelligence (BI)/ Continuous Improvement (CI) to understand how COP can be supported by technology to ensure that critical mass can be achieved in embedding COP behaviours across a wider group Work with BI/CI to map out core functionality across POs to support COP technology roll-out Work with COP to build up and develop their skills in accessing technology, and support the creation of rich and vibrant communities which include valuable resource Using data gleaned from survey to work with staff groups, the WI Steering Group and the national team to define and agree key competencies May 2015 May 2015 September 2015 October 2015 September 2015 January 2016 March 2016 July 2015 Steven Pratt Research Delivery Manager/Workforce Intelligence Lead; supported by John Rouse - Workforce Intelligence Project Manager Steven Pratt/John Rouse Steven Pratt/John Rouse Steven Pratt Workforce/John Rouse

31 CRN: [North East and North Cumbria] Annual Plan Table 6. LCRN Workforce Plan To work with POs and COPs to roll out and embed role outlines To develop and roll out tools to enable effective workforce planning. To create a matrix of key competencies that can be shared with POs to support them in their line management of Portfolio Research support and delivery staff To liaise closely with POs to support the roll-out of the suite of role outlines To develop a competency matrix to allow PIs, POs and core team to be assured as to competencies of staff delivering and supporting research To consider and implement scenario planning to allow for effective resource planning To build/ source effective tools to enable resource planning To roll out tools to core team and POs October 2015 January 2016 March 2016 March 2016 March 2016 March 2016 Steven Pratt/John Rouse Steven Pratt/John Rouse

32 CRN: [North East and North Cumbria] Annual Plan Appendix 1 Risk Register Risk Register as submitted to Executive Group meeting 11 March 2015 Paper 9 - NENC Executive Meeting Risk Register Date: Programme / Unique Ref. Date Workstream Status ID. Identified LPMS implementation Portal Switch off/hub access Open /11/2014 S Robson/N Bleasby Open /01/2015 S Robson/N Bleasby Raised by Description Likelihood Impact Current Status Mitigating Actions Challenging timescale for implementation by 1 April no slippage in the project High implementation plan, CPMS not available to interface UPDATE February First function testing revealed more build work is required, this is likely to add 6 weeks to implementation phase. Project Manager advises that this is realistic, thus mid-may is revised launch date (NB Jonathan Sheffield revealed at Network event that CPMS will not be launched until end-june, therefore this reduces risk to LPMS as national system will still not be available at revised go-live date) UPDATE: March no change Confirmation from national Coordinating Centre that they expect to switch off the Portal end of High March 2015 and all users to have migrated to the Hub. Access issues are still being worked through for the core team. Loss of the Portal without appropriate Hub access will lead to reduced means of communicating both across the team with shared documentation etc and also with POs - critical tool for managing finance returns UPDATE March BI team have developed a migration plan to move all information to the Hub by 20/03/15 and working with individuals teams to support this/mitigate risks Low High Amber Amber High level project management support, effective working relationship with Infonetica Continuing to work with NuTH IT and South Tees to manage appropriate access to Hub to mitigate this. Discussions being held with Host finance team to manage finance returns via alternate means. Migration plan and support for individual teams put in place by BI team Responsible Owner S Robson/N Bleasby S Robson/N Bleasby Action Date Ongoing Ongoing Primary Care - Open /02/2015 S Robson/N Practice Support Bleasby programme Primary Care - Contracting arrangements for Open /02/2015 S Robson/N Bleasby Research Delivery at County Durham & Darlington NHS FT Open 3.2 Feb-15 S Robson/N Bleasby Development of the practice support scheme for Primary Care - a requirement for a new scheme was agreed in November It was made clear that the proposal for the new scheme should make clear how this was different from the previous scheme and that the financial detail should be provided in the financial return (2nd submission) - the level of detail provided is currently insufficient and no narrative document has been produced. Requirement for this prior to any funding for the scheme being released has been reiterated with expectation that documentation will be received by Exec at its March meeting UPDATE March paper on the agenda for meeting Having received a clear steer from the national Coordinating Centre regarding contracting with NECS, a proposal which takes account of Host Organisation concerns regarding financial reporting and performance management, was made whereby NECS would receive funding to support the research delivery team they employ and funding to support GPs would be retained by the Host but administered via joint working between NECS and network team, ensuring appropriate performance management of the new support scheme. This has been poorly received by CCG Contracting Leads, but has full support of the national Coordinating Centre and (further to a second paper to Trust Exec) the Host Organisation - scale of risk to delivery in Primary Care is unknown, but could lead to significant disengagement of Practices and loss of primary care based staff The resignation of the R&D Director and R&D Manager at CDDFT has raised concerns amongst all network teams regarding the ability of this Trust to continue to support research activity. Deputy R&D Manager left in October and has not been replaced, the R&D Facilitator has resgined and Administrator has gone on maternity leave. Anecdotal information suggests that a number of senior research nurses are also seeking alternative employment. Significant risk of total collapse of the delivery workforce and ability of the Trust to deliver studies - will impact on recruitment, which they have already seen dip significantly in Delays in study set-up are already being reported which will have an adverse effect on the ability of the Trust to recruit to time and target, plus risk of reputational damage, esp in relation to commercial studies Medium High High High Medium High Red Red Red Requirements and expectations reiterated to NECS and division 5 leadership tasked with taking responsibility of delivering this to the Executive Group Tim Butler/Hilary Allan SCR to meet with CCG Research Leads in Spring, close working between division S Robson/T 5 leadership and NECS on an ongoing basis Butler SCR/NJB met with the Chief Exec, Medical Director and Assoc MD on 16/02/15 to S Robson/N discuss ongoing support for the Trust/ how the LCRN can help and understanding Bleasby of risks as perceived by both parties. The Trsut are moving to appoint an R&D Director and advertising the Manager post as internal secondment. All central network teams asked to log any issues regarding study set up and delivery with COO. March Executive Ongoing Ongoing

33 CRN: [North East and North Cumbria] Annual Plan Appendix 2 - Information Governance Incidents: action and reporting 1. Background Newcastle upon Tyne Hospitals NHS FT (NuTH) currently manages and reports Information Incidents through the Information governance toolkit (IGT) Serious Incidents Requiring Investigation (SIRI) reporting tool. Information incidents are initially recorded by the affected department onto the Trust risk and incident register Datix. The Datix system generates an alert to the Information Governance Team who will then gather information about the incident. If it is identified as a definite information incident the IG team will register it on the SIRI reporting tool. The tool automatically generates a score for the incident based on a number of criteria. Essentially, how sensitive is the data, how many data records are involved and whether this is a repeat incident. Level 0 and 1 scores are managed locally but a level 2 or above incident automatically generates notification to both Health and Social Care information Centre (HSCiC) and the Information Commissioner who can both take action against the Trust if deemed necessary. The Trust would expect that incidents are added to the SIRI reporting tool within 48 hours of the original report and would include the initial scoring, although that score can change after investigation. 2. Reporting for LCRN In its capacity as the Host Organisation for the CRN: North East and North Cumbria NuTH proposes that incident reporting for the LCRN follows the same process as currently in place for the Trust. An information incident would be reported to the LCRN information governance lead who would establish whether it is a genuine incident. If the incident is to be reported the LCRN lead would raise a Datix incident which would then generate notification through to the Trust IG team who would assist in the investigation. The initial investigation would establish whether the incident needed to be logged on the SIRI reporting tool. Any matters reported within the Trust would simultaneously be reported to the NIHR CRN Coordinating Centre within 48 hours. There are specific issues around LCRN data as the LCRN may be either a Data Controller or a Data Processor 6 on behalf of another organisation. It needs to be established at the early stage of an incident who the actual Data Controller is. If the Controller is not the LCRN then 6 As per the Data Protection Act 1988: Data controller means a person or organisation that determines the purposes for which and the manner in which any personal data are, or are to be processed. In essence, the data owner. Data processor, in relation to personal data, means any person (other than an employee of the data controller) who processes the data on behalf of the data controller.

34 CRN: [North East and North Cumbria] Annual Plan Appendix 2 - Information Governance Incidents: action and reporting they must apply their own reporting and governance mechanisms but for the sake of completeness an incident involving another organisations data that impacts on the LCRN should be reported to the LCRN governance lead and added as a non-reportable (to HSCiC or ICO) incident to the Trust SIRI reporting tool. The Data Controller may have to report the incident to either HSCiC and / or ICO so the ability to cross-reference against NuTH s reporting tool is essential. The Trust IG committee receives quarterly updates on reported incidents and a subset of that report, relating to LCRN incidents will be made available to LCRN. The SIRI reports and information about incidents is releasable under Freedom of Information and it is part of the Trust Information Governance Action Plan to publish incidents quarterly as part of the Organisation Publication Scheme. Other organisations who are the Data Controllers must be made aware that incidents relating to their data may be released under FOI however the Trust would always contact the organisation before release.