The Royal Wolverhampton NHS Trust

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1 The Royal Wolverhampton NHS Trust Trust Board Report Meeting Date: 23 rd February 2015 Title: National Institute for Health Research Clinical Research Network: West Midlands Annual Plan submission Executive Summary: RWT as Host to the Clinical Research Network: West Midlands is required to submit an Annual Plan for to the NIHR Co-ordinating Centre (NIHR CC) by 13 th March. The Annual Plan (Appendix One) sets out the strategic direction for the local Clinical Research Network (LCRN). It includes the specific activities and strategic initiatives to support the achievement of the performance objectives as set out in the NIHR CRN Performance & Operating Framework The plan must be agreed by the Partnership Group and formally approved by the Host Trust Board prior to submission. A Financial Plan for should also be approved and submitted within a similar timescale but the details and final allocation have not yet been released by the DH. The Financial plan will need to be submitted prior to the next Trust Board meeting. An overview of progress on last year s annual plan is provided within this report along with a general update on the LCRN performance to date. Action Requested: 1. To approve the Annual Plan (Appendix One) prior to submission to the Partnership Group for agreement ( ). 2. To note a Financial Plan will be submitted in March 2015 to the National Institute for Health Research Clinical Research Network Co-ordinating Centre and to confirm the process for approval. Report of: Author: Contact Details: Resource Implications: Dr Jonathan Odum, Medical Director Nominated Executive lead for CRN: WM Tel Jonathan.Odum@nhs.net N/a

2 Title: NIHR CRN: West Midlands Public or Private: (with reasons if private) Public Session References: (eg from/to other committees) Appendices/ References/ Background Reading NHS Constitution: (How it impacts on any decision-making) Appendix One: NIHR CRN: WM Annual Plan 2015/16 In determining this matter, the Board should have regard to the Core principles contained in the Constitution of: Equality of treatment and access to services High standards of excellence and professionalism Service user preferences Cross community working Best Value Accountability through local influence and scrutiny Background Details 1.1 CRN: WM Annual Plan The LCRN s performance against the Annual Plan and its Partners will be measured against a set of objectives and targets and include: NIHR CRN high level objectives (HLO s) Clinical Research Specialty objectives CRN Development and continuous improvement objectives Operating Framework compliance indicators CRN Specialty Recruitment goals and targets The Host Executive Leadership Group has had active oversight of the HLOs, recruitment goals and targets and has received regular performance reports. Progress against the more detailed specialty objectives and Annual Plan has been actively managed by the LCRN Senior Management Team and a report recently submitted to the NIHR CC. The first Host/NIHR CC Performance Review meeting has been scheduled for 9 th March Performance against Annual Plan i. To date the LCRN has achieved 81% of our year to date recruitment and we are ranked at 4/15 Networks in England but 2/15 for the amount of funding we will receive based on our activity. This is due to the portfolio balance; the majority of studies are complex Band 2 and 3 studies (which attract higher funding but typically lower recruits), with less than 2% band 1 studies (ie. more simple and easy to recruit to, questionnaire-type studies). We anticipate the same level of funding for and may see an up-lift. Comparing recruits per million population, the LCRN is 12/15. Additional strategic funding has been allocated to Trusts for the remaining 4 months of the financial year to incentivise recruitment and increase resources for study delivery. ii. HLO 4 - reducing the time taken for studies achieving valid R&D Page 2 of 4

3 Title: NIHR CRN: West Midlands permissions (and within 40 days) the CRN is 1/15. iii. iv. The majority of our Trusts and CCGS are engaged with research activity. HLO 7 to increase the number of participants into Dementias and Neurodegenration studies. Year-to-date there have been 800 recruits; the annual target of 446 was achieved a number of months ago. v. The LCRN Infrastructure and Governance arrangements have been successfully established and all objectives met. vi. vii. viii. The local performance management system (LPMS) has been procured and the roll-out and training programme is being developed. The LCRN has developed quality Business Intelligence and performance management reports to support our Partners in the absence of the unified LPMS (above). Trusts have been engaged in ensuring the national data accurately reflects the local picture and a lot of positive feedback has been received in respect to these reports. In the LCRN needs to work more closely with our Partners in achieving HLO 2 recruiting to time and target and HLO 5 - recruiting the first patient into studies (within 30 days of permission). 2.1 CRN: WM Annual Plan The HLO s remain unchanged for but the specialty objectives have been reduced and mapped to the following domains: Increasing the breadth of research engagement in the NHS Delivering a balanced portfolio that meets the needs of the local population and takes into account national priorities Developing a research infrastructure in the NHS to support clinical research A further section includes the LCRN (Host) plans against the Operating Framework and this focuses on governance, business continuity, workforce development, continuous improvement activities, patient and public engagement and involvement. 2.2 The Annual recruitment target for is 65,000 recruits which is an increase of 5,000 from and has been agreed with our Partners based on current studies and studies coming through the pipeline. The funding model for was agreed by the Partnership Group and is based on a median of 3 years activity, capped at +/-15% and a 2.5% top slice which has created circa 1.7m strategic fund. The overall purpose of Strategic Funding is to assist development of the Network; bids were invited based on a set of principles which included: Enhancing recruitment in existing well-performing units Opening new sites for existing trials within the Network Building recruitment in less research-active units NIHR and LCRN priorities: Page 3 of 4

4 Title: NIHR CRN: West Midlands i. To increase the number of people participating in Dementias and Neurodegeneration studies ii. iii. iv. Contribution to the NIHR high level and Specialty objectives Further developing our Primary and Secondary care interface Supporting the delivery of CRN: WM Lead studies for CIs based within the region We are particularly concerned with our ability to achieve HLO 7 to increase the number of participants recruited into Dementia studies, due to the lack of studies coming onto the NIHR portfolio and/or being open to other sites across regions. Significant investment has been made in this area through the use of the Strategic fund and longer term plans have been put in place, but the target will remain challenging in Action: The Trust Board is asked to formally approve the Annual plan and recommend its submission to the Partnership Group for agreement. 3.1 Financial Plan The Host organisation will submit a Financial Plan as part of the Annual Plan which is to be developed in collaboration with the Senior Management Team and Partnership Group and sets out the annual funding allocations to the Host organisation and Partner organisations. We are currently waiting for the guidance and timetable to be released from NIHR CC and indications are this will be available mid-february with a submission date mid-march. Unfortunately the timescales dictated from the NIHR CC could preclude formal approval from the Trust Board. The Board is asked to confirm the process for approval prior to submission to the CC. Action: To note a Financial Plan will be submitted in March 2015 to the NIHR CC and to confirm the process for approval prior to submission. Page 4 of 4

5 CRN: West Midlands Annual Plan 2015/16 1. LCRN plans and goals for contributing to NIHR CRN High Level Objectives Objective Measure CRN Target 1 Increase the number of Number of participants recruited in a participants recruited reporting year into NIHR CRN Portfolio into NIHR CRN Portfolio studies studies LCRN Goal Specific Key local activities for Timescale 650,000 65,000 Please outline up to 3 key initiatives and projects planned for by your LCRN to contribute towards achievement of objective(s); business as usual activities will be assumed and need not be outlined Build upon existing high levels of PIC activity to facilitate and support increased recruitment to NIHR CRN portfolio studies recruiting outside primary care; establish pre-consented patient lists where appropriate Please outline associated timescale(s) July 2015 Increase joint working with specialty leads and partners outside primary care to streamline recruitment pathways to increase participant recruitment for studies supported by primary care and strengthen boundary / speciality collaboration to identify new studies that can run in primary care setting The Annual recruitment target for is 65,000 recruits which is an increase of 5,000 from and has been agreed with our Partners based on current studies and studies coming through the pipeline. The funding model for was agreed by the Partnership Group and is based on a median of 3 years activity, capped at +/-15% and a 2.5% top slice which has created circa 1.7m strategic fund. The overall purpose of Strategic Funding is to assist development of the Network; bids were invited based on a set of principles which included: Ongoing Enhancing recruitment in existing well-performing units Opening new sites for existing trials within the Network Building recruitment in less research-active units NIHR and LCRN priorities: i. To increase the number of people participating in Dementias and Neurodegeneration studies ii. Contribution to the NIHR high level and Specialty objectives iii. iv. Further developing our Primary and Secondary care interface Supporting the delivery of CRN: WM Lead studies for CIs based within the region Significant investment has been made in the priority areas through the use of the Strategic fund and longer term planning will be undertaken throughout 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% Enhanced use of the RSI scheme (including expansion of the Commercial Research Pilot) to incentivise primary care sites to deliver studies to time and target A suite of SOPs are to be implemented by the Industry Operations team and delivered in collaboration with identified Divisional contacts; all Divisions to adhere to the same processes. Supported by the roll out of a Commercial Clinical Trials Workshop, the relevant SOPS for HLO 2 include: o Industry Delivery Support SOP for New Research Teams and/or sites o o Commercial Study Performance Management Action Plan SOP Study Milestones Procedure; ensuring realistic and achievable targets are confirmed at the outset. 12 Months In addition, the Business Intelligence and Portfolio Team will continue to produce monthly activity reports to support Trusts (network supported sites) in managing their performance against a verified target. The reports consist of a PDF summary 1

6 Objective Measure CRN Target 3 Increase the number of commercial contract studies delivered through the NIHR CRN B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period A B Number of new commercial contract studies entering the NIHR CRN Portfolio 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 LCRN Goal Specific Key local activities for Timescale and RAG reports to allow for active study performance management which includes commercial activity. These activities will support both locally led and multicentre Trials. Local information is collated in the SAMT (Study Activity Monitoring Tool) and is used to inform and influence the national RAG reports in the absence of CPMS. 80% 80% Work collaboratively with academic partners to ensure successful, feasible and timely submission of study applications to approval bodies to support achievement of performance metrics. The Business Intelligence and Portfolio Team will produce monthly activity reports (as outlined under HLO2a) to support Trusts in managing their recruitment to target. Local information is collated in the SAMT (Study Activity Monitoring Tool) and is used to inform and influence the national RAG. The Green report will be used to inform the CI led studies In addition, consider the development of a suite of SOPs to support Trusts and RDMs in delivering the non-commercial portfolio for both CI lead and PI led studies across the region. Once the national non-commercial feasibility process is introduced, consider implementing a local suite of SOPs similar to those outlined under HLO 2a Division 5 (Primary Care) to work with Division 2 colleagues to promote to industry a hub and spoke model for recruitment to commercial diabetes studies. 75% n/a Promote our nationally recognised expertise in engagement of community pharmacy in research and the RPS Research Ready Scheme and continue to develop opportunities to deliver commercial contracted studies in a community pharmacy setting. The Head of Study Support Services (Karen Hampshire) is developing the CRN: West Midlands Early Contact and Engagement with Researchers work stream to support our local Chief Investigators and research teams. This work stream is to ensure all studies where we are the lead are properly supported following national Study Support Services criteria. Where appropriate, this will include liaison with the Senior Industry or Industry Operations Manager. The Industry and Business Delivery Manager (Emma Patterson) is currently working with the local AHSN to develop a series of workshops to encourage the development of Medical Device protocols that would be eligible for portfolio adoption and that would be deliverable in the NHS setting. Continue to liaise with local commercial companies (MAC and Synexus) and promote the benefits of portfolio adoption Rolling out the mentoring toolkit across specialties to ensure West Midlands has the capacity to set-up and deliver all commercial studies that approach CRN. Rebranding and review of existing toolkit including good news examples of who it has helped. Promotion across the West Midlands. Work collaboratively with Dedicated Research Centres such as Synexus, MAC Clinical Research to advocate Primary Care PIC model as a mechanism to increase NIHR CRN portfolio recruitment overall and increase attractiveness of the West Midlands as region able to deliver for commercial companies. 12 Months 12 Months In Place 2015 Ongoing Ongoing June 2015 Ongoing 4 Reduce the time taken for NIHR studies to achieve NHS Permission through CSP Proportion of studies obtaining NHS Permission at all sites within 40 calendar days (from receipt of a valid complete application by NIHR CRN) 80% n/a Developing the LCRN Research Management and Operational Group and CRN: West Midlands Research Support Group to support strategic and operational aspects of NHS Permission process. This will be done by having greater consistency across our core and Trust RM&G/ R&D Dept. plus input from the RDM s. onwards Developing a Research Support Communication plan to ensure consistent and 12 Months 2

7 Objective Measure CRN Target LCRN Goal Specific Key local activities for Timescale timely messages are sent to our research support team within core teams, Trusts R&D/ RM&G Dept., Principal Investigators and other key external stakeholders (e.g. academia, CTUs, local commercial sector) Developing the LCRN performance management tool to support local management of CSP portfolio studies. Identifies pre valid studies in pipeline, studies pending review or in suspension, studies that are going to potentially breach. Once a study has breached it provides information to the Senior Research Support Team in supporting core teams or RM&G/ R&D Dept. through escalating barriers to NHS Permission. Version 3 for release April 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 Developing LCRN Early Contact and Engagement with Researchers work stream to support our local Chief Investigators and research teams. This work stream is to ensure all studies where we are the lead are properly supported following national Study Support Services criteria. Investigate using the performance management tool (as described under HLO4) to support RDMs in ensuring that studies are ready to recruit FPFV after NHS Permission or SIV. This is likely to be initiated by Version 3. In the interim and overseen by the Senior Industry Manager, the following suite of SOPs will be used to actively manage activity: - Industry Delivery Support SOP - Commercial Study Performance Management Action Plan - Study Milestone SOP - Industry Escalation Process In Place by July B: Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued The Business Intelligence and Portfolio Team will produce monthly activity reports to support Trusts (network supported sites) in managing their performance against a FPFV metrics. Once the impact of the HRA is known on the study support services team, would like to consider utilising current governance staff to support industry studies by attending SIVs and actively supporting study set up teams to ensure they meet the 30 day target 80% 80% Front-load planning of primary care study set-up requirements, planning of clinics, and work in the same time frame with study approvals to ensure recruitment can begin as soon as NHS assurance has been issued. Review October 2015 Ongoing Investigate using the performance management tool to support RDMs and Trusts in ensuring that studies are ready to recruit FPFV after NHS Permission. In the interim, the Business Intelligence and Portfolio Team will continue to produce monthly activity reports (as outlined under HLO2a) to support Trusts in managing their performance against the FPFV metric. The Green report will be used to inform the CI led studies. July Increase NHS participation in NIHR CRN Portfolio Studies A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies Consider the development of a suite of SOPs to support Trusts and RDMs in delivering the non-commercial portfolio for both CI lead and PI led studies across the region. Once the national non-commercial feasibility process is introduced, consider implanting a local suite of SOPs similar to those outlined under HLO 5a. 99% 99% There is one small Community Trust which is not participating in research; CD and COO to meet with Senior Clinical and leadership team to review support required to initiate research (PIC activity initially) at this Community Trust. Review from October

8 Objective Measure CRN Target B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies LCRN Goal Specific Key local activities for Timescale 70% 70% Currently achieving 76% (above target) of Trusts supporting commercial contract studies; the Industry team will continue to work with RDMs and Trusts to identify new investigators The Industry Team have developed the Industry Delivery Support SOP for New Research Teams and/or sites in support of this and will launch this in. Industry Leads to work closely with RDMs and CRSLs to promote this initiative C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 25% 25% Continue to grow the RSI scheme to encourage increased participation of General Medical Practices. Streamline and target GCP training in RSI practices to allow individual practices to conduct a variety of NIHR CRN portfolio studies including the more complex CTIMP studies. Continue to engage with the 22 CCGs operating within the LCRN via the Management team. Specialty Leads and Research Champions to mutually support the delivery and promotion of NIHR CRN primary care portfolio studies. Ongoing 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 Enter the LCRN goal for recruitment to Dementias and Neurodegeneration 1100 Enter the LCRN goal for recruitment to Dementias and Neurodegeneration 1100 Implementation of a Division 4 business development plan to increase the number of DeNDRoN studies placed within the LCRN. WM will be measuring at what stage in the research life cycle we are involved in research and finding sites, with the aim that the WM will be the place of choice and be named as a site at the earliest stage possible. The overall aim is to increase the number of DeNDRoN studies within the WM. Maximising the opportunities for taking part in research by developing relationships with and engaging care providers other than NHS and care/nursing homes e.g. sheltered housing and social care for promotion of JDR. Increasing WM healthy controls (aged 50+) is an ideal cohort for a WM HEI research team. Scoping and engaging local CIs to ensure that researchers are signposted to CRN early contact and engagement team to identify and appropriately plan pipeline DeNDRoN portfolio research for successful delivery. Implementation 2015/16 ongoing delivery Implementation 2015/16 ongoing delivery Implementation 2015/16 ongoing delivery ` 4

9 CRN: West Midlands Annual Plan 2015/16 2. LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty objectives Draft Specialty Objectives for mapped to domains DOMAIN 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 Baseline LCRN activities and initiatives to contribute to achievement of objective(s) 1.1 Cancer Increase the opportunities for cancer patients to take part in research studies, regardless of where they live, as reflected in National Cancer Patient Experience Survey responses Number of LCRNs which have an action plan to increase access in each subspecialty (e.g. by opening studies, increasing awareness and forming referral pathways for access to research) 15 Q29 = 86 Q30 = 29 Q31 = 63 Working with Sub speciality leads, locality managers and local research and clinical teams, develop a balanced portfolio of studies for the locality and set up patients pathways to ensure smooth referrals. Develop portfolio maps to reflect the local portfolio and include contact details. Promote the balanced portfolio through each Expert Advisory Group. Ensure activity is recorded in LPMS to reflect workload by both referring and accepting sites. 1.2 Children All relevant sites that provide services to children are involved in research 1.3 Critical Care 1.4 Dermatology Increase intensive care units participation in NIHR CRN Portfolio studies Increase NHS participation in Dermatology studies on the NIHR CRN Portfolio 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 Number of sites recruiting into Dermatology studies 95% 94.4% 17/18 Sites 80% Based on 18 Adult ICUs in 13 Acute Trusts ~ 50% recruited during 2014/15 Discuss opportunities to grow laboratory contributions to these studies; query work to promote the role of the PI in these Histopathology professionals and other laboratory professionals (Link in with development of PI Oversight training Workforce Development Leads). Only The Royal Orthopaedic Hospital has not recruited children this year to date. We are however supporting ROH with set-up of its first children s commercial study. In addition, ROH has expressed interest in a non-commercial study which we will open once the QC issues with the lab kits are resolved by the sponsor. Across the LCRN there are 17 Acute Trusts with intensive care units and 50% (13 units) are currently recruiting to critical care studies. Patient recruitment into main & supporting critical care studies is 37/100,000 population. To increase the proportion of intensive care units recruiting into studies region wide meetings will be arranged to raise awareness, increase engagement and improve participation in studies. Appropriate ICUs will be identified and targeted to open suitable studies, including the less research active units sites As a Specialty there are CRSLs covering Sites in the North, Central and South localities. In January 2015, the Dermatology Specialty group met, bringing together representatives from Dermatology study teams, Trust R&D, PCPIE, and Primary Care, the LCRN (Research Delivery, Portfolio Management, Industry Management and Communications). As for all specialties, ongoing review of resource will be performed to support the expanding Dermatology portfolio. The group will meet quarterly reconvening in April and will be inviting clinicians from each Dermatology Site in the region interested in and/or delivering Dermatology studies. Relevant Dermatology studies will be highlighted to the Primary Care Specialty Group to support patient recruitment. To help raise the profile of the Dermatology studies, we aim to find patients prepared to share their experience of taking part in Dermatology studies for publication. The Specialty will engage and support the development of the West Midlands PCPIE strategy, which includes contacting relevant patient groups. BADBIR is the largest recruiting study within the Specialty, open at 12 sites and last year recorded 197 recruits, 591 ABF units. A key objective is to enable as many Dermatology Sites to increase their recruitment for this study and its partner studies: BSTOP and imap. Regular review of the study data will help establish if improvements can be made. The commercial Portfolio across the region has continued to increase. Several sites are recruiting well to them; some of them are UK top recruiters for particular studies. It is important to ensure this growth continues to create a track record that will make West Midlands a destination of choice for Industry. To further support raising the profile of Dermatology studies some Sites are relaying study information via monthly newsletters and during clinical meetings. This communication method is to be maintained. 5

10 ID Specialty Objective Measure Target Baseline LCRN activities and initiatives to contribute to achievement of objective(s) New Sites should be supported to embrace these opportunities. This can be achieved by identifying interested PIs, engaging speciality doctors, and making their Sites research ready for interventional trials. There have been considerable interests of studies investigating new biologics and biosimilars for psoriasis and new drugs for skin cancer and pre-skin cancerous lesions. To expand access of interventional studies to where they are not opened, the use of secondary care PIC sites should be encouraged. This approach was used successfully this year to support recruitment for a commercial trial and will be used for a non-commercial vitiligo study that is due to open soon in this Region. 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% Based on 15 Trusts ~ 33% recruited during 2014/15 This is a new specialty for the LCRN with our first CRSL appointed in December Across the LCRN there are 15 Acute Trusts that provide an on-site ENT service with in-patient care. Patient recruitment into main & supporting ENT studies is 12/100,000 population. To increase the proportion of acute NHS Trusts recruiting into ENT studies appropriate ENT departments will be targeted to open suitable studies. Meetings will be arranged with existing and new PIs to raise awareness, increase engagement and improve participation in studies. 1.6 Gastroenterology Increase NHS participation in Gastroenterology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Gastroenterology studies on the NIHR CRN Portfolio 90% Based on 15 Trusts ~ 67% recruited during 2014/15 Across the LCRN region there are 15 Acute Trusts providing Gastroenterology services. Patient recruitment into main & supporting Gastroenterology studies is 36/100,000 population. To increase the proportion of acute NHS Trusts recruiting into Gastroenterology studies, regional meetings will be arranged to raise awareness, increase engagement and improve participation in studies. A strategy will be developed to engage new PIs and raise awareness with any Trusts not actively recruiting into gastroenterology studies to improve participation. This will include identifying and opening easier, less complex studies in centres which have not participated in research before. The LCRN will also look to supporting a potential new initiative where Gastroenterology Trainee Registrars may participate in LCRN led research. The LCRN will consider taking forward the PIC Utilisation process forward to cross LCRN sites. The benefit of this process is linking research support, delivery and buy-in from Trusts that may not undertake Gastroenterology research. 1.7 Haematology Increase NHS participation in Haematology studies on the NIHR CRN Portfolio Proportion of NHS Trusts undertaking Haematology studies in each LCRN 50% 13/29 45% Of the LCRN, 29 NNS Trusts, 9 Trusts (31 %) are undertaking haematology studies mapped to main specialty. In total 13 Trusts (45 %) are recruiting to haematology studies. One further Trust (HEFT) has two haematology main specialty studies open awaiting first recruit; when the first patient is recruited, this will take the percentage to 34% and 48% respectively. The RDM and CRSL will review which studies are suitable for other LCRN Trusts, with particular focus on RWT and Walsall. 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% Based on 4 Trusts ~ 100% recruited during 2014/15 Across the LCRN there are 4 NHS Major Trauma Centres (3 Adult and 1 Children s). Patient recruitment into main & supporting I&E studies is 26/100,000 population. The objective is currently being met but will continue to be monitored and supported by active performance managing the I&E portfolio and through the continued identification of suitable noncommercial studies. 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% Based on 10 Trusts ~ 33% recruited during 2014/15 Across the LCRN there are 10 NHS Emergency Departments and 33% are currently recruiting to I&E studies. Patient recruitment into main & supporting I&E studies is 26/100,000 population. Close links with the existing PI s will continue to be supported by early identification of potential studies, supporting the non-commercial EOI process, active performance management of the I&E portfolio, and 6

11 ID Specialty Objective Measure Target Baseline LCRN activities and initiatives to contribute to achievement of objective(s) by ensuring early intervention and support of studies with a local RAG rating of red or amber. To increase the proportion of acute NHS Trusts recruiting into I&E studies appropriate ED departments will be targeted to open suitable studies Musculoskeletal Increase NHS participation in Musculoskeletal studies on the NIHR CRN Portfolio Number of sites recruiting into Musculoskeletal studies on the NIHR CRN Portfolio sites Clinical Research Lead (CRL) for Division 5 and Musculoskeletal Clinical Research Specialty Lead (CRSL) Dr Tom Sheeran was appointed November 14. The Musculoskeletal portfolio is an active portfolio in the region. The portfolio has gained momentum following CRSL meetings with and supporting potential Rheumatology PIs at Walsall Manor Hospital. Over the coming year an initiative is to proactively engage in this development activity as well as maintaining strong recruitment to studies from existing recruiting sites Ophthalmology Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Ophthalmology studies on the NIHR CRN Portfolio 60% Based on 14 Trusts ~ 57% recruited during 2014/15 Across the LCRN there are 14 acute Trusts providing ophthalmic services and 57% are currently recruiting to Ophthalmology studies. Patient recruitment into main & supporting Ophthalmology studies is 12/100,000 population. Close links with the existing PI s will continue to be supported by early identification of potential studies, supporting the non-commercial EOI process, active performance management of the Ophthalmology portfolio, and by ensuring early intervention and support of studies with a local RAG rating of red or amber. To increase the proportion of acute NHS Trusts recruiting into Ophthalmology studies appropriate Ophthalmology departments will be targeted to open suitable studies Renal Disorders Increase the proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which actively engage renal and urological patients in research Proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which implement Patient Carer & Public Involvement and Engagement (PCPIE) strategies for Renal Disorders research 25% 4% Work with CRSLs on best approach to build portfolio across renal and urology clinical areas, and subsequently build engagement strategy in line with LCRN PCPIE strategy Build on current PCPIE representation on renal group and 2 recent examples of PCPIE participation in assisting with study design Map research activity at main, satellite and paediatric renal units to ensure widest participant engagement 1.13 Stroke Increase the proportion of NHS Trusts, providing acute Stroke care, recruiting to Stroke studies on the NIHR CRN Portfolio 1.14 Surgery Increase NHS participation in Surgery studies on the NIHR CRN Portfolio Proportion of NHS Trusts, providing acute Stroke care, recruiting participants into Stroke studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting patients into Surgery studies on the NIHR CRN Portfolio 80% 100% Keep up to date with local PI/ research staff/ R&D and service issues by regular meetings with staff and contact with PIs through the clinical leads. Make sure issues are dealt with speedily, and resolved, where possible. Assess merits of the provision of a peripatetic stroke research nurse. Ensure all Trusts providing acute stroke care, continue to recruit into studies. 85% Based on 16 Trusts ~ 94% recruited during 2014/15 Across the LCRN there are 18 Acute/Acute Specialist Trusts providing surgical services and 94% are currently recruiting to Surgery studies. Patient recruitment into main & supporting Surgery studies is 18/100,000 population. Although the objective is currently being met we will continue to monitor and support by actively performance managing the Surgery portfolio and through the continued identification of suitable non-commercial studies. Through continued and improved engagement of surgeons at all trusts with CRN research via group meetings and symposia, as well as individualised targeted approaches. Clinicians will be supported in clinical research with enhanced research nurse support where necessary and new multi-centre trials or studies opening in the next 6 months will be championed to ensure as many WM sites open as possible. 7

12 DOMAIN 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 Target Baseline 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 2.2 Cancer Increase the number of cancer patients participating in studies, to support the national target of 20% cancer incidence Proportion of Ageing-led studies which are multicentre studies Number of LCRNs recruiting at or above the national target of 20%, or with an increase compared with % 67% Once a CRSL is in place the (CRL/RDM/Portfolio Manager) plan to facilitate Ageing Specialty group meetings and include the CRSL in reviewing recruitment to the portfolio and uptake of studies by sites. We plan to identify new local links with interest in delivering Ageing portfolio. To support this initiative we will engage with the National Ageing Specialty links to identify studies that can be delivered as multicentre studies recruits which is less than the target of 20% - on current performance we are aiming for 15% Work with Sub speciality leads to ensure we have a balanced portfolio of studies across West Midlands which includes both interventional and non interventional studies. Ensure referral pathways are established for the rarer cancers. In collaboration with NCRI support sub speciality leads to work with national CSGs to ensure we develop a balanced portfolio. 2.3 Cancer Increase the number of cancer patients participating in interventional trials, to support the national target of 7.5% cancer incidence Number of LCRNs recruiting at or above the national target of 7.5%, or with an increase compared with recruits which is less than the target of 7.5% - aiming for 6% Work with Sub speciality leads and locality managers to ensure patients are offered the opportunity to participate in interventional studies. Ensure referral pathways are established for the rarer cancers and where appropriate commercial 2.4 Cancer Deliver a Portfolio of studies including challenging trials in support of national priorities Number of LCRNs recruiting into studies in: Cancer Surgery Radiotherapy Rare cancers (cancers with incidence <6/100,000/year) Children's Cancer & Leukaemia and Teenagers & Young Adults 15 CRN WM has recruited to all categories. NIHR are not asking LCRN to define rare cancers as data not available Promote studies through Expert Advisory Groups and locality managers. Ensure portfolio maps are amended to reflect the local portfolio along with contacts for referrals. Ensure robust referral pathways are established. 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 the six Cardiovascular Disease subspecialties 15 Recruitment to all 6 subspecialties within LCRN 4 CRSLs covering identified responsibilities across all 6 sub-specialties Build on performance that showed recruitment to all 6 sub-specialties, totalling 47 multi-centre studies Ensure growth in number of local CIs Build on successes with AF studies through access to LCRN strategic funding bid e.g. Sandwell and West Birmingham Hospitals for BBC-AF Registry, IMPRESS-AF, and EAST for which SWBH is one of the highest national recruiters 2.6 Diabetes Increase support for areas of Diabetes research where traditionally it has been difficult to recruit Number of LCRNs with at least one research site recruiting into diabetic foot studies on the NIHR CRN Portfolio 15 2 sites in LCRN Build on recent successes in recruiting to diabetic foot studies including DRN528 at UHNM by continuing to recruit to DRN819 at RWT with a view to opening further studies. Continue work to increase access to diabetes studies through stronger collaboration between acute Trusts and Community Trusts and/or Primary Care (either acting as PIC sites or research sites) e.g. UHNM and SSoTP and Primary Care North Work with GP Champions and CRSLs in Diabetes and Primary Care to increase the number of commercial studies that GP Practices are able and willing to deliver, by building on the success of the local Research 8

13 Ready scheme in primary care. 2.7 Diabetes Increase access for people with Type 1 Diabetes to participate in Diabetes studies on the NIHR CRN Portfolio early after their diagnosis Number of LCRNs approaching people with Type 1 Diabetes to participate in interventional Diabetes studies on the NIHR CRN Portfolio within six months of their diagnosis 15 1 study in LCRN Build on recent successes in recruiting to Type 1 diabetes studies that includes DRN581 and DRN552 (ADDRESS2) Further assess patient pathway to ensure early identification of patients for which Type 1 diabetes has been confirmed and work with Partner Organisations on how/when best to approach them for consent to studies Ensure growth in number of local CIs 2.8 Gastroenterology Increase the proportion of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio Number of participants (per 100,000 population), recruited into Gastroenterology studies on the NIHR CRN Portfolio 15 36/100,000 population main & supporting 19/100,000 population main only Across the LCRN region there are 15 Acute Trusts providing Gastroenterology services. Patient recruitment into main speciality Gastroenterology studies is 19/100,000 population and 36/100,000 population into main & supporting Gastroenterology studies. The objective is currently being met but will continue to be monitored and supported by actively performance managing the Gastroenterology portfolio and through the continued identification of suitable non-commercial studies Identify and open larger studies, with less complex pathways, to enable increased recruitment regionally, and new multi-centre trials or studies opening in the next 6 months will be championed to ensure as many WM sites open as possible. Support a balanced portfolio at each site as there are currently more complex phase II/III studies on the GI portfolio. 2.9 Genetics Increase access for patients with rare diseases to participate in Genetics studies on the NIHR CRN Portfolio Number of LCRNs recruiting into multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium 14 Achieved and will continue CRN West Midlands is recruiting through the UK Rare Genetic Disease Research Consortium; the Birmingham Women s Hospital has signed the Musketeer s Memorandum. The following genetics studies are approved under the Agreement and are open and recruiting at the sites listed: 1. NIPSIGEN - Clinical translation of NIPD for single gene disorders (BWH) 2. INSIGNIA: Exploring mutational signatures in humans (BWH) 3. Timing of Primary Surgery for Cleft Palate (BCH) 4. Genetic basis of cranial malformations (BCH) 5. Investigation of the genetic basis of renal tract abnormalities (BCH) 6. HumGenDis (BWH) 7. GeMCaS (ROH) All the studies except investigation of the genetic basis of renal tract abnormalities (BCH) are multicentre Haematology Increase access for patients to Haematology studies undertaken by each LCRN Number of LCRNs recruiting into studies in at least three of the four following Haematology subspecialties : Haemoglobinopathy, Thrombosis, Bleeding disorders, Transfusion 15 Achieved and to maintain LCRN is recruiting to studies in three of the four haematology sub-specialties (Thrombosis, Bleeding disorders, and Transfusion): Four haemoglobinopathy studies have identified; three are open and one in set-up. The RDM and CRSL have a meeting scheduled to discuss which studies might be suitable for CRN WM Trusts treating patients with sickle cell disease or thalassemia, with a focus on UHCW and on SWBH where the regional haemoglobinopathy centre is based Hepatology Increase access for patients to Hepatology studies on the NIHR CRN Portfolio 2.12 Infectious Diseases and Increase access for patients to Infectious Diseases and 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) Number of LCRNs recruiting into antimicrobial resistance research studies on the NIHR CRN Portfolio 15 9 acute Trust (64%) recruited during 2014/15 Across the CRN West Midlands region there are 15 Acute Trusts providing Hepatology services and 9 (60%) are currently recruiting to Hepatology studies. Patient recruitment into main & supporting Hepatology studies is 10/100,000 population. Close links with the existing PI s will continue to be supported by early identification of potential studies, supporting the non-commercial EOI process, active performance management of the Hepatology portfolio, and by ensuring early intervention and support of studies with a local RAG rating of red or amber. To increase the proportion of acute NHS Trusts recruiting into Hepatology studies appropriate Hepatology departments will be targeted to open suitable studies Trusts recruited Across the CRN West Midlands region there are 8/29 Trusts (28%) recruiting into antimicrobial resistance 9

14 Microbiology Microbiology studies on the NIHR CRN Portfolio during 2014/15 (ID&M) research, and patient recruitment is 37/100,000 population. To increase the proportion of NHS Trusts recruiting into antimicrobial resistance research appropriate departments will identified, mapped and targeted to open suitable studies. Close links with the existing PI s will continue to be supported by early identification of potential studies, supporting the non-commercial EOI process, active performance management of the portfolio, and by ensuring early intervention and support of studies with a local RAG rating of red or amber. Regional Lead for Laboratory Medicines to support the Specialty Lead and RDM by regularly reviewing the portfolio and by developing opportunities for engagement with Consultant Microbiologist s work to promote the role of the PI in these professionals and other laboratory professionals (Link in with development of PI Oversight training Workforce Development Leads) 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 Achieved and to maintain Attract new studies with local CIs utilising successful local patient identification procedures from Trust pathology databases New PATHFINDER study should add 750 band 2 metabolic patients to recruitment. Build on success of UHCW achieving status to be one of only 6 ENETS (European Centres of Excellence for Neuroendocrine Tumours) in the UK (from February 2015), to attract more Phase 3 Endocrine and Cancer studies. Ensuring advantage is taken where Trusts are merging their pathology services to share best practice with participant identification e.g. UHCW and Burton FT Consultant Chemical Pathologists active in this area. Work to promote the role of the PI in these professionals and other laboratory professionals (Link in with development of PI Oversight training Workforce Development Leads) 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 20% 0% The Specialty has an appointed Clinical Research Speciality Lead (CRSL), Prof. Thomas Dietrich. The CRSL and RDM plan to increase local collaborative working with the Primary Care Specialty, to facilitate delivery of dental studies adopted on the portfolio that recruit in a primary care setting. Previously, the region has successfully recruited patients from primary care to the Interval dental study so has the infrastructure to allow for this. The region also benefits from the University of Birmingham s School of Dentistry that has over 100 Dental, Therapy, and Biomaterial students enrolled each year. There are a large number of postgraduate research students together with support staff present in the school. The school continues to grow and is well placed to meet the demands and challenges of the coming years. The largest recruiting study at a single site is Molecular Genetic Investigations of Amelogenesis Imperfecta, whilst the Outcomes of Periodontal Therapy in Rheumatoid Arthritis (OPERA) study (Co adopted to Oral and Dental) is the largest recruiting study associated to the specialty in the region, open at three sites. The CRSL wishes to raise the profile still further of research in the region and having led a number of commercial studies has set a challenge to open more. The CRSL feels that this year s specific objective for the Specialty relates to portfolio generation rather than portfolio delivery and therefore are difficult to control/influence through the LCRN. However, through other channels an application to NIHR/RfPB (PB-PG ) has been made which includes a significant primary care component, and if funded, would contribute to achieving these objectives. B Proportion of participants recruited from a primary care setting into Oral and Dental studies on the NIHR CRN Portfolio 30% 0% NB* 89 patients were recruited at Birmingham Dental Hospital but most likely the majority were referred from primary care, but this position means the baseline is 0% for primary care. The CRSL and RDM plan to increase local collaborative working with the Primary Care Specialty, to facilitate delivery of dental studies adopted on the portfolio that recruit in a primary care setting to lead to an increased proportion of participants recruited from the primary care setting. Work with the Early Engagement team to encourage researchers to broaden recruitment setting and include primary care where applicable. Work with the Information managers to use the implemented LPMS/CPMS systems to track participants recruited from primary care setting. 10

15 2.15 Primary care Increase access for patients to NIHR CRN Portfolio studies in a primary care setting Proportion of NIHR CRN Portfolio studies delivered in primary care settings 15% 859 studies showing recruitment at LCRN during of these studies are in primary Care setting Baseline = 9% The LCRN has approximately 950 GP practices. Of these practices, the proportion of practices recruiting to primary care portfolio studies across the LCRN (excluding those sites just undertaking the Million Women study) was 32% in 2014/15. This exceeded the 25% target set for 2014/15 and we will aim to further expand engagement in 2015/16 via the Research Facilitators and the GP champions to those practices not yet research capable to increase the opportunities for patients to participate in NIHR studies. As of 1 st December 2014, 71 studies had recruited in a primary care setting for the year 14/15. In addition 56 studies, recruiting outside primary care, were supported by the LCRN primary care infrastructure. Combining these figures in 14/15 15% of LCRN portfolio studies have been recruited in or supported by primary care settings. To achieve and exceed the 2015/16 target of 15% we are going to: Continue to advocate the established primary care PIC model as a robust patient recruitment pathway to support recruitment from other specialties to the NIHR CRN portfolio. Continue to grow the RSI scheme to encourage increased primary care site participation, which will subsequently offer more opportunities for patients to be involved in NIHR CRN Portfolio studies. Streamline and target GCP training in RSI practices to allow individual primary care sites to conduct a variety of NIHR CRN portfolio studies including the more complex CTIMP studies Continue engagement with community pharmacy to participate and conduct NIHR CRN portfolio studies. Aiming to increase study participation over and above the 8 studies supported in 14/15. Continue to engage with the 22 CCGs operating within the LCRN via the Management Team, Specialty Leads and Research Champions to mutually support the delivery and promotion of NIHR CRN primary care portfolio studies. Build on successful initial steps to further increase the number of practices capable of delivering commercial contract studies Renal Disorders Increase NHS participation in Renal Disorders studies on the NIHR CRN Portfolio A. Proportion of acute NHS Trusts recruiting into multicentre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 30% 53% Build on performance by ensuring continuance or replacement of high recruiting studies Increase Renal research nurse capacity by application to LCRN strategic fund Make sure that successful recruiters are able to share their techniques and methods with others, and that poor recruiters can discuss problems with colleagues, managers and clinical leads, so that barriers are removed and problems resolved speedily. Continue monthly staff meetings to allow this networking activity to happen. B. Proportion of Renal Units recruiting into multi-centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 80% 88% Assess the balance between general and specialist renal research nurses required to deliver a broader range of multi-centre RCTs e.g. building on identified issues with PD_CRAFT regarding availability of peritoneal specialist research nurses Establish number and configuration of local renal databases and their usefulness for patient identification 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 and Pneumonia 15 6 Trusts recruited during 2014/15 Across the LCRN region there are 6 Trusts recruiting into respiratory disorders main disease areas of Asthma, COPD and Pneumonia research. Patient recruitment into main & supporting respiratory studies is 18/100,000 population. Close links with the existing PI s will continue to be supported by early identification of potential studies, supporting the non-commercial EOI process, active performance management of the Respiratory Disorders portfolio, and by ensuring early intervention and support of studies with a local RAG rating of red or amber. To increase the proportion of NHS Trusts recruiting into Asthma, COPD and Pneumonia research appropriate departments will identified, mapped and targeted to open suitable studies 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 Make sure each Trust with stroke research staff has at least 5 RCTs open, with a good spread across acute/prevention/ rehabilitation/translational. This will allow recruitment of patients throughout the whole clinical pathway. Ensure a steady flow of home-grown studies on the portfolio. Make sure that successful recruiters are able to share their techniques and methods with others, and that poor recruiters can discuss problems with colleagues, managers and clinical leads, so that barriers are removed and problems resolved speedily. Continue monthly staff meetings to allow this networking activity to happen. Make sure that each research active site has as many PIs as possible (ideally all consultant staff) to enable opening of the optimal number of studies and to ensure buy-in from the clinical teams. Ensure there are sufficient research nurses/therapists/staff to do the screening/ recruitment/ follow-up at each site. 11

16 Support the UHB bid to become a HSRC. Support ambulance based stroke studies (RIGHT-2) through use of the strategic fund. Look proactively for primary care based studies, as these tend to recruit well 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 Ensure a sufficient number of studies are open. Ensure that new and upcoming studies are known and that we are considered as centres. This will be achieved by networking (national and international meetings) and high Quality EOIs, as well as by continued success in current recruitment. Ensure we support hyperacute studies generated by local researchers or with local researcher as coapplicants (e.g. SmartCap, Headfirst, MAPS-2, RIGHT-2, ImPact2b) Ensure 24/07 research nurse cover (including on-call) resource applied for through UHNM application to LCRN strategic fund. Ensure all stroke consultants and appropriate middle grades are PIs in hyperacute studies at HSRCs. Involve the stroke early assessment nurses in research. Continue close working with A&E, ITU, and Imaging with stroke research nurses working in Emergency Departments. 12

17 DOMAIN 3: RESEARCH INFRASTRUCTURE Developing research infrastructure (including staff capabilities) in the NHS to support clinical research ID Specialty Objective Measure Target Baseline 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 1 of sub speciality leads appointed. Appointed to a radiotherapy sub speciality leads post. Consider developing a primary care sub speciality lead post. Continue to support sub speciality leads at Expert Advisory Groups, educational events and with locality managers. 3.2 Anaesthesia, Perioperative Medicine and Pain Management Establish links with the Royal College of Anaesthetists Specialist Registrar networks to support recruitment into NIHR CRN Portfolio studies Number of LCRNs where Specialist Registrar networks are recruiting into NIHR CRN Portfolio studies 4 1 ~ WM-TRAIN recruit to studies [baseline number of studies to be confirmed] Patient recruitment into main & supporting Anaesthesia, Perioperative Medicine and Pain Management is 37/100,000 population. The actual number of studies the network recruits into will be confirmed The West Midlands Trainee Research in Anaesthesia and Intensive Care (WMTRAIN) has established links with the Royal College of Anaesthetists and supports recruitment into main & supporting NIHR CRN Portfolio studies. Links with Dr Joyce Yeung is co-founder of West Midlands Trainee Research in Anaesthesia and Intensive Care Network (WMTRAIN) have been made & she will help facilitate an opportunity to meet the trainee group & present about CRN / research portfolio Will work proactively with WM-TRAIN to identify and increase the proportion of appropriate studies trainees can recruit into. 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% 3% Between Jan and Mar 2015 all 28 organisations will be approached about engaging in JDR. The aim is that all WM NHS Trust CEOs will have formally signed up to this initiative by the end of 2015/16. To work with individual partner organisations to define a roll out plan tailored to the services and trust sites. To address organisations concerns regarding JDR in a timely manner to maximise engagement. To report on JDR numbers as a region within CRN newsletters as a feedback mechanism for increasing volunteer registration. To ensure all sites have a dedicated researcher administrator and all users received training and on-going support. To use regular reports to performance manage research sites regular use of JDR and timely contacting of volunteers. To use scoping information regarding relevant support groups and non-nhs settings to inform these stakeholders of JDR and promote, working with JDR champions and WM Dementia Carer Reference Group members. Care Home Research Facilitators and delivery staff to promote within care homes/sheltered accommodation and other relevant settings. To develop a SOP for managing identification of volunteers from another trust (this will be shared nationally). Engage GPs in JDR and roll out promotional material in collaboration with Division 5. Collaborate with relevant partners to promote JDR such as Dementia Friends. 3.4 Dementias and Neurodegeneration Increase the global and psychometric rating skills and capacity of LCRN staff supporting DeNDRoN studies on Proportion of LCRN staff who support DeNDRoN studies who have successfully 0.4 Baseline = 68% A Rater induction day was held 5 th Feb Along with other delivery staff that have accessed other training held by the CC, 19 people 13

18 ID Specialty Objective Measure Target Baseline LCRN activities and initiatives to contribute to achievement of objective(s) (DeNDRoN) the NIHR CRN Portfolio completed Rater Programme Induction and joined the national Rater database 3.5 Infectious Diseases and Microbiology 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) Number of LCRNs maintaining a named Public Health Champion Number of staff trained in frequently used Mental Health study eligibility assessments 14 (Assuming all DeNDRon studies and based on all recent induction trainees 5 th Feb registering before 31 st Mar 2015) 15 Named Public Health Champion 139 Currently have 17 people PANSS trained. 1 of these will be PANSS Lead. Target 20. have accessed the induction. Individuals will be followed up to ensure they register on the national Rater database. In conjunction with the WFD team the Raters will be supported to ensure the robust skills framework is implemented and experience is logged routinely. Further Rater induction days will be held throughout the year to achieve the target, as the number of Trusts and delivery staff opening and recruiting to DeNDRon studies increase. Partner organisations are all keen to support DeNDRoN studies and so the WM potentially has a large number of people that will support DeNDRoN studies. A focus for 2015/16 will be to develop a resource of Practice Leads to ensure more Raters are developed across the WM geography and recruiting sites. The WM aims to attract more DeNDRoN research into the area (commercial and non-commercial) as well as work with local Chief Investigators to provide the practical experience for new Raters and utilise the expertise of experienced Raters. Urgent Public Health Research Champion identified as Dr Neil Jenkins, Consultant in Infectious Diseases at HEFT with support from CRN WM Clinical Lead for Laboratory Medicine, Dr. Owen Driskell. Urgent Public Health Research Plan in place includes an Urgent Public Health Research training schedule and has been shared with Partner Organisations. Champion to raise the awareness of research protocols in the Microbiology Laboratory Community. Opportunity to use this research strategy to improve clinical services in response to emerging infections by raising awareness that the strategy exists and the concomitant Public Health protocols. Engagement with Consultant Microbiologists, engagement with Academic Microbiologists. Already planning an Extraordinary meeting of the regional consultant microbiologists and linking in with the West Midlands ACB which will allow access to Clinical Scientists in Microbiology. Work to promote the role of the PI in these professionals and other laboratory professionals (Link in with development of PI Oversight training Workforce Development Leads). We are working with the CC to ensure we have a number of PANSS lead raters who will support other less experienced MH delivery staff in their learning and application of MH eligibility assessments. We will work with the national pool of clinical PANSS trainers to ensure the need for training is met across the WM. With dedicated WFD Lead resource we will have coordination of the mental health delivery workforce and ensure all staff access training, shadowing, refresher training and training in practice as appropriate. A learning log will be kept by all MH delivery staff. A PANSS Lead will enable WM to contribute to PANSS learning materials (PANSS videos) as well as mentorship to ensure all MH delivery staff evidence a high standard and reliability of applying MH eligibility assessments. Regular communication with partner organisations means the RDM is always made aware of new MH delivery staff. PANSS training will

19 ID Specialty Objective Measure Target Baseline LCRN activities and initiatives to contribute to achievement of objective(s) form part of new MH staff development. 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 No named leads as of yet. Baseline 0. Potential leads already identified. To advertise opportunities using sub-specialty role outline to agree expectations. CRSL for neurological disorders to agree 2015/16 objectives with successful candidates. 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 1 LCRN appointed a Midwife Champion on 15 October

20 CRN: West Midlands Annual Plan 2015/16 3. LCRN plans against the Operating Framework POF Area Operating Framework requirement POF Ref Information required LCRN Governance The Host organisation shall develop 3.12 Assurance that a framework and system and maintain an assurance framework are in place to be provided by the Host including a risk management system organisation nominated Executive Director s signature on Annual Plan coversheet and submission of a copy of the latest version of the LCRN s risk Research Delivery 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 LCRN management team provides excellent study performance management, in line with the standards and guidance issued by the national CRN Coordinating Centre, in 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 CRN WM - Appendix One Risk Registers.p RWT initiating new process. Work to be completed prior to submission deadline to the MHR CC on 13/3/15 The LCRN can confirm that a revised Public Health Research Plan has been developed and is In place, ready to be activated. Dr. Neil Jenkins Consultant in Infectious Diseases Neil.jenkins@nhs.net Tel: Supported by Dr. Owen Driskell, Lead for Laboratory Medicine owen.driskell@nih.ac.uk Mobile: Audit being undertaken by Host internal auditors, Baker Tilley and will take place week commencing 23 rd February Head of Study Support Services (Karen Hampshire) is the CRN: West Midlands link champion for Study Support. This post is to ensure that research support is linked and aligned to research delivery. The network understands the value of this and has recently invited this post to join the LCRN Senior Manager Team to ensure there is effective strategic and operational communications process from research support teams to delivery. Milestones & outcomes once complete As per plan Audit report to be presented at Audit Committee () Timescale Not known 16