NIHR Local Clinical Research Networks

NIHR Local Clinical Research Networks Annual Plans 2014-15 Guidance WORKING DRAFT Version 0.4

WORKING DRAFT v0.4 Document Control This document is updated and issued annually by the national CRN Coordinating Centre. Readers should ensure that the latest version is being viewed. Document Information Document Title NIHR Local Clinical Research Networks : Annual Plans 2014-15 : Guidance Effective Date 1 April 2014 to 31 March 2015

WORKING DRAFT v0.4 Contents 1. Background 4 2. LCRN Annual Plan 2014-15 overview 4 3. Local performance management and local goals 6 4. LCRN reporting and progress review meetings 6 5. Structure of the LCRN Annual Plan 2014-15 7 6. Host Organisation Accountable Officer Sign-off 12 7. Submission of plans 12 8. Queries 12 Appendices Appendix 1 Indicative template for LCRN infrastructure arrangements: Progress and Plans against the POFs and the 2014-15 LCRN Development and Improvement Objective Appendix 2 Indicative template for LCRN 2014-15 local plans and goals in support of NIHR CRN HLOs Appendix 3 Indicative template for LCRN plans against Objectives relating to cross-cutting activities Appendix 4 Indicative template for LCRN plans against the Objectives for Clinical Research Specialties for 2014-15

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 1. Background 1.1. This working draft of the LCRN Annual Plan Guidance 2014-15 has been prepared in advance of final publication of the NIHR CRN Performance and Operating Frameworks and is based on NIHR CRN Performance and Operating Frameworks Working Draft Version 0.5, which is currently with the Department of Health, and therefore the content of this guidance may be subject to change. 1.2. The NIHR Clinical Research Network is the clinical research delivery arm of the NHS in England, tasked with supporting the rapid set-up and effective conduct of studies so that researchers can gather the robust evidence needed to improve treatments for NHS patients. 1.3. The NIHR Clinical Research Network has national leadership and management from the CRN national Coordinating Centre, and is embedded in the NHS through 15 Local Clinical Research Networks (LCRNs). 1.4. CRNs provide and organise the NHS Support resources for NIHR CRN Portfolio studies, drive clinical research delivery performance, and champion the role of clinical research in the NHS in the region at every level. 1.5. The NIHR CRN Performance and Operating Frameworks Working Draft Version 0.5 set out the operational framework for LCRNs and the national Performance Framework that LCRN performance will be measured against, including the NIHR CRN High Level Objectives and Objectives relating to cross-cutting activities. As the Performance Framework indicates, additional objectives relating to Clinical Research Specialties and LCRN development and improvement will be set on an annual basis as part of the LCRN annual planning process. Objectives for Clinical Research Specialties for 2014-15 will be communicated once these are finalised. For 2014-15 there is a single LCRN development and improvement objective: to complete the establishment of the LCRN hosting, governance and management arrangements to ensure that the LCRN is able to effectively deliver its activities and that the terms of the Host contract are fulfilled. 1.6. Within their Annual Plans LCRNs are expected to set out their planned local goals for each CRN objective, for review and agreement by the national CRN Coordinating Centre. 2. LCRN Annual Plan 2014-15 overview 2.1. 2014-15 represents a transitional year for the CRN. It is acknowledged that while the LCRN structure will be operational from 1 April 2014, some arrangements may be interim and will be finalised in-year in 2014-15. The Annual Planning process and the structure and content requested in LCRN Annual Plans for 2014-15 reflects this situation, takes a light touch approach where possible, and includes: a streamlined local reporting exercise to capture and enable incorporation of intelligence on research delivery performance in the first half of 2013-14, and strengths, weaknesses, priorities and good practice from 2013-14 local research network arrangements, to strengthen and inform planning for 2014-15; 4

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 building on the LCRN Transition Plan, a section to provide assurance of progress made in developing and implementing the new LCRN infrastructure and working arrangements, and plans for further development and embedding of these arrangements in 2014-15; a section setting out plans for 2014-15 for improving performance in research delivery; 2.2. It is anticipated that the format and requested content of LCRN Annual Plans will evolve over time. 2.3. The LCRN Annual Financial Plan forms part of the LCRN Annual Plan; however it will be submitted separately to the main LCRN Annual Plan and specific additional guidance will be issued for the Financial Plan. 2.4. The LCRN Annual Plan 2014-15 provides an opportunity to set out the specific activities and strategic initiatives the LCRN will undertake during 2014-15 to support achievement of the NIHR CRN performance objectives as set out in the NIHR CRN Performance and Operating Frameworks - Working Draft Version 0.5. 2.5. The LCRN Annual Plan 2014-15 is separate to, and distinct from, the LCRN Transition Plan which set out the local plans for transition from existing Clinical Research Network structures into the new LCRN structure in the year 2013-14. 2.6. The LCRN Annual Plan 2014-15 requires the LCRN to set out robust local plans for developing and embedding the LCRN infrastructure, and the LCRN s priorities and strategic direction in relation to the delivery of the NIHR Clinical Research Network Portfolio of studies and associated local goals. Plans should be developed with close reference to, and must be in line with, the NIHR CRN Performance and Operating Frameworks. 2.7. Final funding allocations will be confirmed and notified to LCRN Host organisations, in early 2014, dependent on confirmation of allocations by the Department of Health. The Annual Plan will therefore need to be initially developed with reference to the LCRN indicative budget allocation. 2.8. LCRN Annual Plans should build on LCRN Transition Plans, and interim LCRN structures and operating arrangements. Plans should take account of the opportunities and any identified challenges presented by the new LCRN structures, and should be collaboratively developed through consultation and discussion with Partner Organisations, the local Clinical Research Leadership Group, and other local stakeholders. The LCRN Partnership Group is expected to be active in helping develop and scrutinising the LCRN Annual Plan, including the financial plan. 2.9. Preparation and submission of the LCRN Annual Plan 2014-15 is the responsibility of the LCRN Host Organisation. The expectation is that Local Transition Facilitation Leads (LTFLs) will facilitate collaborative development of plans but will not be responsible for writing the LCRN Annual Plan 2014-15 as part of their LTFL role. 5

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 2.10.As discussed at the Host meeting on 27 November 2013, a suite of LCRN Guidance is under development to provide additional information in support of the NIHR CRN Performance and Operating Frameworks to assist Host organisations in delivering the Host contract. The LCRN Guidance may also be useful in relation to the 2014-15 LCRN Annual Planning process, and will be provided in January 2014. 3. Local performance management and local goals 3.1. LCRNs are expected to proactively manage performance locally as set out in the NIHR CRN Performance and Operating Frameworks, with clearly defined routes of support and escalation. 3.2. The CRN Performance Framework (Part A of the CRN NIHR CRN Performance and Operating Frameworks - Working Draft Version 0.5 Frameworks) and use of performance objectives, measures and national and local goals (where applicable) are intended to be instructive and provide a platform for discussion between the LCRN Host Organisation, Partner organisations and other stakeholders, in relation to local research ambition and delivery, and associated resource requirements. The underlying aim in setting any local goals is to increase access to high quality studies for NHS patients and to ensure that the NHS is the global partner of choice for the life sciences industry; local goals for patient recruitment in particular can only be set by the NHS partners, supported by the LCRN Leadership Team and management staff, and should be ambitious. 4. LCRN reporting and progress review meetings 4.1. LCRNs will be expected to report on progress against their plans and will be required to submit quarterly financial reports and an annual report to the NIHR CRN Coordinating Centre. Further guidance regarding the requirements of these reports will be issued in due course by the NIHR CRN Coordinating Centre. 4.2. Progress Review meetings between the NIHR CRN Coordinating Centre and the LCRN leadership and senior management team will be arranged within 2014-15. These meetings will provide the opportunity to discuss performance and the successes and challenges of LCRNs. In addition, a national review of Clinical Research Specialty performance will be conducted annually by the CRN Coordinating Centre. 4.3. The timing and format of these meetings will be confirmed at a later date and will be arranged in consultation with LCRNs and national Clinical Research Specialty Leads. 6

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 5. Structure of the LCRN Annual Plan 2014-15 5.1. LCRN Annual Plans for 2014-15 should follow the structure outlined below: Coversheet (template provided) Section A Review of 2013-14 performance and local intelligence gathering Section B Development and embedding of LCRN infrastructure: LCRN Development and Improvement Objective Section C LCRN plans for 2014-15 for research delivery against the CRN HLOs, objectives for cross-cutting functions and Clinical Research Specialty objectives 5.2. For 2014-15 the Coordinating Centre is requesting minimal narrative content in LCRN Annual Plans, which will instead be based predominantly around a series of templates, and LCRNs are encouraged to use bullet points and provide information succinctly wherever possible. This does not preclude LCRNs from having their own supplementary documents for local engagement purposes. Further details of expectations and information requested in the various sections are outlined below. Coversheet 5.3. The coversheet provides an at a glance guide to the composition of the LCRN and should be at the front of the plan. Individual LCRN coversheet templates have been pre-populated, as far as possible, and provided to LCRN Host Organisations along with this document. The coversheet of the LCRN Annual Plan must be signed by the Host Accountable Officer prior to submission, to confirm Host Organisation Board sign-off of the Annual Plan. Section A: Review of 2013-14 performance and local intelligence gathering 5.4. It is critical that planning for 2014-15 is informed by a review of performance by the existing networks and organisations that will transition to the new LCRN. For this reason, the 2013-14 annual reports of the current 102 LRNs will be brought within the 2014-15 annual planning for the 15 LCRNs. 5.5. Section A of the LCRN Annual Plan 2014-15 should incorporate a local intelligence report, capturing a review of activity and performance in the first 6 months of 2013-14, and local priorities and good practice from existing local Network structures (2013-14) to inform the LCRN s plans for 2014-15. The report should be based upon verified mid-year data a (from the 2013-14 Quarter 2 data-cut) to be provided by the CRN Coordinating Centre, and forecast Year End performance, and no further documentation to this end will be required from current local research networks at the end of 2013-14, except for 2013-14 year-end finance reports. Please note that: current local research network Host Organisation finance contacts have recently been contacted by the CRN CC Finance Team regarding their responsibilities in relation to 2013-14 year end financial reporting. 7

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 5.6. It is intended that the local intelligence report will formally and briefly capture, and enable sharing of, achievements and challenges in the LCRN geography to date, and will support and promote a collaborative approach to planning. It is acknowledged that considerable dialogue and planning is already underway; this process serves to formally document and support this work rather than duplicating it. 5.7. It is anticipated that Local Transition Facilitation Leads may facilitate coordination of intelligence gathering; however the exercise is envisaged as a collaborative effort involving input from current LRN leadership. Where current networks map to more than one LCRN, the report is expected to cover only the perspective of NHS organisations that will form part of each LCRN and this may require that some Local Research Network Managers provide input to more than one LCRN intelligence report. a Indicative data to be provided by the CRN Coordinating Centre for 2013-14 (Q1 and Q2) 5.8. The following mid-year verified data will be provided to Host organisations by early January 2014: LCRN recruitment and number of studies open in Q1 and Q2 of 2013-14 (all Clinical Research Specialties combined) with a breakdown of commercial/noncommercial studies and recruitment, plus recruitment and number of studies for studies which are current and in follow-up. Plus comparative data for 2011-12 and 2012-13. The above data broken down by Clinical Research Specialty. 5.9. Host organisations will also be provided separately in mid-january 2014 with: LCRN recruitment and number of studies open in Q1 and Q2 of 2013-14 (all Clinical Research Specialties combined) with a breakdown of commercial/noncommercial studies and recruitment, plus recruitment and number of studies for studies which are current and in follow-up, broken down by NHS Trust organisations within the LCRN footprint. Plus comparative data for 2011-12 and 2012-13. Note: for this exercise, Primary Care recruitment data will be provided at LCRN level only and not by provider. To support more detailed analysis and planning, an Excel spreadsheet/pivot table containing recruitment data for Q1 and Q2 of 2013-14 and data for 2011-12 and 2012-13 ordered by: o the 6 divisions o the 12 themes o the 30 SGs o by LCRN(s) o by trust o by site o by financial year o by month o by design type (Interventional/Observational/Both/Not Specified) o by commercial/non-commercial o by study 8

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 o by active status (open, closed in follow-up, closed follow-up complete - alone and any combination) o by CI led studies within LCRN 5.10. Current LRN managers within LCRN geographies will have intelligence on forecast recruitment data for the full 2013-14 year. Also, Host Organisations and LTFLs have previously been provided with details of the local workforce composition and Local Research Network 2013-14 Annual Financial Plans and 13-14 Mid-year data. In addition, LCRNS are asked to draw on the collective local intelligence at Clinical Research Specialty/Division and Trust level when reviewing performance in 2013-14 and in planning for 2014-15. 5.11.The local intelligence report is expected to consist of a very brief commentary (limited to several paragraphs) against the data provided and other local intelligence, collated from current networks whose member organisations will form part of the LCRN, outlining: successes in 2013-14 current challenges, risks and mitigating actions priorities and opportunities for 2014-15 Section B: Development and embedding of LCRN infrastructure: LCRN Development and Improvement Objective(s) 5.12.Section B of the LCRN Annual Plan centres on the LCRN Development and Improvement Objective for 2014-15: to complete the establishment of the LCRN hosting, governance and management arrangements to ensure that the LCRN is able to effectively deliver its activities and that the terms of the Host contract are fulfilled. 5.13. This section of the plan provides an opportunity for the LCRN to provide assurances and outline plans relating to the development and embedding of LCRN infrastructure arrangements and ways of working, in line with the principles and requirements set out in Part B of the NIHR CRN Performance and Operating Frameworks - Working Draft Version 0.5. This section of the plan should consist of a completed version of the template to be provided to Host Organisations in early January 2014; for indicative template see Appendix 2. LCRNs are asked to indicate a Green/Amber/Red status for each area in the fifth column of the table. For areas rated Amber or Red, please provide a brief commentary in the LCRN Commentary column of the template. LCRNs are also asked to provide the information indicated in the Additional Information Required column in the LCRN Commentary column of the template. The Additional Information Required column includes a number of requests for the provision of details of lead individuals for a range of functions; the CRN Coordinating Centre will provide an additional template in early January to be used for provision of this information. 9

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 5.14.It is acknowledged that dependent on progress, some of the items of assurance requested in the template may already have been provided to the CRN Coordinating Centre in the LCRN s Transition Plan; where this applies the information need not to be provided again but instead a reference to the relevant section of the LCRN Transition Plan may be entered. Section C: 2014-15 LCRN plans for research delivery against the CRN HLOs, Objectives for cross-cutting functions, and Clinical Research Specialty Objectives Plans for delivery against CRN High Level Objectives 5.15.The NIHR CRN High Level Objectives (HLOs) are the national, overarching objectives for Clinical Research Network research delivery, and are set out in Table 1 of the CRN NIHR CRN Performance and Operating Frameworks - Working Draft Version 0.5. 5.16.This section of the LCRN Annual Plan 2014-15 should be presented in table format using the template to be provided to Host Organisations in early January 2014; for indicative template see Appendix 4. LCRNs are asked to outline succinctly the key activities/actions the LCRN plans to undertake in 2014-15, to build upon current performance levels, and to capitalise on opportunities arising from the new LCRN configuration, and towards achievement of the NIHR CRN HLOs. Please also provide associated milestones/ outcome(s) once complete, timescales for the actions and leads for the actions. Please keep text to a minimum; the use of bullet points is encouraged. 5.17.LCRNs are encouraged to ensure that plans presented in this section are informed by and build on local performance, successes, challenges and priorities collated and captured in the 2013-14 performance review exercise presented in Section A of the LCRN Annual Plan 2014-15 (see section 5.2). 5.18.The HLOs have national reach, and it is expected that the Host Organisation will evaluate and report on local contributions to these national performance metrics. In addition to submission of Appendix 3, LCRN Host Organisations are requested to agree appropriate supplementary local recruitment goals for HLO1, as outlined below. Agreeing local recruitment goals 5.19.Planning and agreeing measurable local recruitment goals is the responsibility of the LCRN Host Organisation and it is essential that LCRN Hosts engage with Partner Organisations, existing clinical network managers, local Clinical Research Leads and other stakeholders, as part of the annual planning process, to agree local goals and resources required to support their achievement. 5.20.LCRNs are asked to provide local goals for 2014-15 for: Overall annual recruitment by the LCRN Annual recruitment for each Clinical Research Specialty at local network level 10

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 5.21.The CRN Coordinating Centre is still considering the question of whether we require Host Organisations to provide total annual recruitment goals for each LCRN Partner Organisation, and we will clarify this issue as soon as possible. 5.22.Local goals should be recorded where noted within the relevant templates (see indicative templates in Appendices 2 and 4). 5.23.It is noted that the timing of annual planning requires LCRNs to submit their local recruitment goals for the following year, prior to the existing operational year being completed and significantly in advance of recruitment figures being verified in the final data cut for 2013-14 (25 April 2014). Therefore LCRNs will be required to submit provisional goals as part of the LCRN Annual Plan 2014-15. 5.24.Following publication of verified annual 2013-14 recruitment data, LCRNs will have until the end of April 2014 to notify the CRN Coordinating Centre whether they wish to make substantial amendments to their local goals. If there are no substantial amendments, the provisional goals will be accepted and verified according to the final 2013-14 recruitment figures, as per the final data cut on 25 April 2014. 5.25.The intention is that the accuracy of predictions against actual recruitment will be reviewed at a national level, with the expectation of spreading successful methodology and learning to other regions/clinical Research Specialties over time, as LCRN structures embed and develop. Plans against the Objectives relating to cross-cutting activities 5.26.Objectives relating to cross-cutting activities to support research delivery are set out in Table 2 of the CRN NIHR CRN Performance and Operating Frameworks - Working Draft Version 0.5 and are grouped into five domains, based upon established balanced scorecard methodology: Customer Financial Internal business processes Learning and development Promoting research participation and culture 5.27.LCRNs are asked to identify plans for addressing the objectives for cross-cutting activities, and associated timescales and leads, by completing the template to be provided in early January 2014; an indicative template is presented in Appendix 3. 5.28.As noted above, LCRNs are encouraged to ensure that plans presented in this section are informed by and build on local performance, successes, challenges and priorities, collated and captured in the 2013-14 performance review exercise, presented in Section A of the LCRN Annual Plan (see section 5.2). 11

LCRN Annual Plan Guidance 2014-15 WORKING DRAFT v0.4 5.29.Findings from reviews undertaken by CLRNs in 2013-14 into the service provided to research stakeholders may also be pertinent and will be made available via LTFLs in early January 2014. Local goals and plans for delivery against Objectives for Clinical Research Specialties 5.30.From April 2014, the NIHR CRN will move to a framework of 30 Clinical Research Specialties for the purposes of engagement with clinical research communities and to support performance management of the NIHR CRN research portfolio. 5.31.In this section of the Annual Plan, LCRNs are asked to identify local goals and planned activities against the national Clinical Research Specialty Objectives, using the template to be provided by the national CRN Coordinating Centre in January; an indicative template is provided in Appendix 4. 5.32.Again, LCRNs are encouraged to ensure that plans presented in this section are informed by and build on local performance, successes in 13-14 and any challenges and priorities captured as part of the 2013-14 performance review, presented in Section A of the LCRN Annual Plan 2014-15. Local plans to support the NIHR priority area of dementia 5.33.The LCRN Annual Plan should set out how the LCRN will deliver on this priority. LCRNs will ensure that plans presented in this section support and build on the NIHR CRN's existing initiatives relating to the Prime Minister's challenge on dementia. LCRNs are required to work with CRN Coordinating Centre to support development of their plans. 5.34.The Department of Health is funding the development of a nationally consistent consent-for-approach system to support recruitment to dementia studies, and the creation of a new IT system to support delivery. The system will be developed and implemented through the RAFT project in partnership with the Alzheimer s Society and Alzheimer s Research UK across England throughout 2014-15. Implementation in the local NHS has two key use cases: (A) use of system by the LCRN to support recruitment to studies, and (B) use of the system by local dementia services as a means of collecting and recording service users consentfor-approach about research, which will enable dementia services to meet the research criteria for accreditation to the Royal College of Psychiatrists Memory Service National Accreditation Programme (RC Psych MSNAP). The deadline for implementation across England of use case (A) is December 2014. The implementation of use case (B) is expected to proceed over a longer time period. 5.35.LCRN Annual Plans should include provision to: Project manage and lead the local the implementation in dementia services across the LCRN of business processes to enable the use of the RAFT system to recruit people to dementia studies Identify studies appropriate for inclusion in the RAFT system during 2014-15 Engage local PIs and trusts in the implementation and use of the RAFT system 12

LCRN Annual Plan Guidance 2014-15 Identify local research support staff who will use the system to support recruitment to dementia studies, and support their training on the RAFT system Engage with and identify NHS dementia services wanting to implement the RAFT system as a local consent-for-approach system in 2014-15 and support them to implement it, making promotion of the system a normal element of the care pathway 6. Host Organisation Accountable Officer Sign-off 6.1. The LCRN Annual Plan must be agreed by the LCRN Partnership Group and formally approved by the Host Organisation Board prior to submission to the national CRN Coordinating Centre. The coversheet of the LCRN Annual Plan must be signed by the Host Accountable Officer prior to submission, to confirm Host Organisation Board sign-off of the plan. 7. Submission of plans 7.1. Annual Plans should be submitted by 5pm on Monday 24 February 2014 to the CRN Coordinating Centre Planning and Reporting Team, by email to NIHRCRN.PlanningReporting@nihr.ac.uk. 8. Queries 8.1. Please direct any queries about this guidance document or the LCRN Annual Planning process to the Transition Programme Team in the first instance, by email to NIHRCRN.TransitionProgramme@nihr.ac.uk. 13

WORKING DRAFT v0.4 Appendix 1 Indicative template for LCRN infrastructure arrangements: Progress and Plans against the POFs and the 2014-15 LCRN Development and Improvement Objective Area of LCRN Operating Framework LCRN Governance Leadership Team Management arrangements Research Delivery Patient, Carer and Public Aspects of Assurance or LCRN Milestones Host Organisation sign-off of LCRN Governance Arrangements POFs Ref Additional Information Required LCRN RAG** status 2.4 Provide RAG status and commentary if applicable Please select Green, Amber or Red rating to indicate current status Nominated Executive Director identified 2.6, 2.7 Provide RAG status and commentary if applicable Scheme of delegation and Host Board controls 2.8 Provide RAG status and commentary if applicable and assurances established Assurance Framework & Risk Management 2.12, Provide RAG status and commentary if applicable System developed 2.13 Business continuity arrangements are in place for the LCRN in the event of a pandemic or other emergency 2.14 Provide RAG status and commentary if applicable Plans in place for inclusion of LCRN activity in the local internal audit programme of work Implement and maintain a documented LCRN escalation process LCRN Partnership Group 2.19-2.29 2.16 Provide RAG status and commentary if applicable 2.17 Provide RAG status and commentary if applicable Provide the name, job title and organisation of the Chair. Provide a copy of Terms of Reference and list of members (name, job title and organisation) Appointment of LCRN Leadership Team, including as a minimum; the nominated executive director; the LCRN Clinical Director; and LCRN Chief Operating Officer 3.1 Provide RAG status and commentary if applicable Clinical Research Specialties 4.5- Provide a list of names of local Clinical Research 4.10 Specialty Leads and their clinical profession Research Delivery Divisions 4.11- Provide the names of the individuals appointed as 4.18 LCRN Research Delivery Manager for Divisions 1-6 Research Delivery Cross-Cutting Team 4.19 - Provide RAG status and commentary if applicable 4.23 LCRN Support Team 4.24, Provide RAG status and commentary if applicable 4.25 LCRN Executive Group 4.30 Provide details of the membership of the LCRN Executive Group Clinical Research Leadership Group 4.31 Provide details of the membership of the Clinical Research Leadership Group Operational Management Group 4.32, Provide confirmation the Group has been established 4.33 in accordance with the provided TOR All LCRN organisations adhere to specified national systems, Standard Operating Procedures and operating manuals in respect of research delivery. The Host Organisation ensures that the LCRN management team provides excellent study performance management in order that all NIHR CRN Portfolio studies recruit to agreed timelines and targets Promotion of research opportunities in line with the NHS Constitution for England, including 5.1-5.18 Provide confirmation the LCRN has an engagement and communication strategy in place for stakeholders involved in the research delivery and governance pathway Provide a brief outline of local plans for implementation, delivery and oversight of research management and governance services by the LCRN Provide the name of the appointed Industry Operations Manager 6.1-6.4 Provide confirmation that a PCPIE workplan is in place Provide the name of the senior leader with identified LCRN Commentary In this column please add brief comments if the RAG rating is Red or Amber.

Involvement and Engagement (PCPIE) Continuous Improvement Workforce Development Corporate Support Services Information Systems Communications Information Governance informing patients about research conducted within the LCRN and actively involving and engaging patients, carers and the public in research Promoting and sustaining a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance Workforce development plan developed in partnership with relevant stakeholders and other local learning providers Provision of management processes or support services identified as necessary within the Host Organisation to enable effective running of the LCRN Appropriate, reliable and well maintained information systems and services are in place and fully operational Dedicated communications function and delivery plans in place, and budget line identified Promote and enable good Information Governance (IG) relating to all areas of LCRN activity WORKING DRAFT v0.4 responsibility for PCPIE within the LCRN 7.1-7.5 Provide the name of the senior leader with identified responsibility for continuous improvement within the LCRN 8.1-8.7 Provide confirmation that a workforce development plan is in place 7.3 Provide the name of the senior leader with identified responsibility for LCRN workforce development 9.1-9.3 Provide confirmation all specified Corporate Support Services are in place 11.1-11.22 Provide the name of the identified lead for the Business Intelligence function Confirm LPMS systems are in place as required Confirm arrangements are in place for provision of an LCRN Service Desk function and provide contact details 12.1 Confirm a dedicated communications function is in place 12.2 Confirm a communications work programme is in place 12.3 Confirm the LCRN is operating in compliance with brand guidelines 13.1-13.8 Confirm a process is in place for timely reporting to the CRN Coordinating Centre of all information governance incidents arising from LCRN funded activities Provide baseline (2013) IG toolkit scores for the LCRN Host Organisation and Partner Organisations, and confirmation of attainment of Level 2 or above on all requirements or any exceptions that arise from or impact on LCRN funded activities Provide the name of the individual with specialist IG knowledge identified to respond to IG queries relating to LCRN funded activities ** RAG status guidance for LCRN self-assessment Arrangements in place Arrangements not yet in place but plans developed and on schedule Plans not agreed/implementation significantly delayed/behind schedule 15

WORKING DRAFT v0.4 Appendix 2 Indicative template for LCRN 2014-15 local plans and goals in support of NIHR CRN HLOs Objective Measure Target LCRN Goal/Target LCRN actions/activities for 2014-15 Milestones and outcome(s) once actions complete Timescale Lead 1 Increase the number of participants recruited into NIHR CRN Portfolio studies Number of participants recruited in a reporting year into NIHR CRN Portfolio studies 650,000 Enter the overall LCRN goal for 2014-15 recruitment Please enter as appropriate; the number of lines shown is an example not an expectation Please enter as appropriate Please outline timescale for actions Please identify who is responsible for the action(s) outlined 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% B: Proportion of non-commercial studies managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 80% 80% C: Proportion of non-commercial studies not managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 80% 80% 3 Maintain the percentage of commercial contract studies delivered through the NIHR CRN Number of commercial contract studies on the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies, on an annual basis 75% n/a 4 Reduce the time taken to achieve NHS Permission through CSP for NIHR studies Proportion of studies obtaining NHS Permission within 40 calendar days (from receipt of a valid complete application) 80% 80% 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% B: Proportion of non-commercial studies managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 80% C: Proportion of non-commercial studies not managed by Registered CTUs achieving first participant recruited 80% 80%

WORKING DRAFT v0.4 Objective Measure Target LCRN Goal/Target LCRN actions/activities for 2014-15 Milestones and outcome(s) once actions complete Timescale Lead within 30 calendar days of NHS Permission being issued 6 Increase NHS Trusts participation in NIHR CRN Portfolio Studies A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 98% 98% B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 70% 70% C:Primary Care Related Metric to be agreed Tbc Tbc 17

WORKING DRAFT v0.4 Appendix 3 Indicative template for LCRN plans against the Objectives relating to cross-cutting activities Domain Objective Measure Target Planned LCRN actions in 2014-15 Timescale Lead 1 Customer Deliver a responsive and flexible service that meets the needs of the NIHR CRNs customers and stakeholders 2 Financial Deliver robust financial management using appropriate tools and guidance A: LCRN Host organisation s performance as a Host (annual survey of all LCRN partners) B: Satisfaction of participants in LCRN portfolio studies (annual survey) C: Satisfaction of patients / carers / others actively involved in supporting delivery of LCRN studies (annual survey) D: Impact of patients, carers and public actively involved in supporting delivery of NIHR CRN portfolio studies (annual assessment) E: Stakeholder understanding and perception of LCRN role (annual survey) A: Percentage variance (allocation vs expenditure) quarterly and year-end - This will be coordinated nationally and therefore no information is required as part of LCRN Annual Plans - Please outline key actions Please outline timescale for actions - - - 0% Please identify who is responsible for the action(s) outlined 3 Internal Business Processes Deliver and report accurate data in a timely and efficient manner B: Percentage of financial returns completed on time 100% Percentage of LCRN data uploaded within agreed reporting timescales 97% 4 Learning and Growth Develop a flexible workforce to deliver the NIHR CRN portfolio of studies A: Proportion of LCRN-funded staff with Personal Development Reviews 100% B: Proportion of completed inductions for new starters 100% C: Proportion of CRN-funded staff with documented supervisory arrangements including appropriate professional accountability for clinical staff D: Profile of NIHR CRN funded staff relating to workforce data (annual survey) E: Number of actively involved patients, carers and the public accessing learning and development resources 100% - - 5 Promoting Research Participation and Culture All providers increase recruitment into clinical research A: Proportion of LCRN Partners that have increased recruitment 80% B: Proportion of LCRN Partners reporting their own research KPIs to their organisation s Board 100%

WORKING DRAFT v0.4 Appendix 4 Indicative template for LCRN plans against the Objectives for Clinical Research Specialties for 2014-15 Clinical Research Specialty Objective Measure Target LCRN goal for number of participants/patients with a diagnosis to be recruited in 2014-15 To be confirmed To be confirmed To be confirmed To be confirmed To be completed at a local level LCRN actions/activities to achieve objective To be completed at a local level Milestones/timescale To be completed at a local level 19

WORKING DRAFT v0.4 Appendix 5 Indicative template for LCRN plans to support delivery of dementia initiatives Deliverable Planned LCRN actions in 2014-15 Milestones and outcomes once actions completed Timescale Lead Project manage and lead the local the implementation in dementia services across the LCRN of business processes to enable the use of the RAFT system to recruit people to dementia studies Identify studies appropriate for inclusion in the RAFT system Engage local PIs and trusts in the implementation and use of the RAFT system Identify local research support staff who will use the system to support recruitment to dementia studies, and support their training on the RAFT system Identify dementia services wanting to implement the RAFT system as a local consent-for-approach system and support them to implement it (Enter additional LCRN deliverables as appropriate) 20