Update – April 2015 Champions for Research Support Meeting Delivering research to make patients, and the NHS, better

Update on Transition On 1 April 2015, the new single CRN Coordinating Centre came into being with new contract terms. Continuing programme of work underway to ensure a smooth transition between old and new structure.

Delivering during transition CRN CC will continue to support Local CRNs throughout move into the new structure Continuing to undertake prioritisation of ongoing projects to ensure business as usual and current performance levels can be maintained throughout transition LCRNs are in the process of writing annual reviews for the first year of LCRN activity

OK to ask 2015 Campaign launched on 15 April Support the campaign on social media: –#NIHRoktoask#NIHRoktoask OK to ask hour on Twitter - #oktoaskhour –Cancer (Wednesday 15 April, 8-9pm) –Diabetes (Wednesday 22 April, 8-9pm) –Stroke (Wednesday 29 April, 8-9pm) –Dementias and neurodegeneration (Wednesday 6 May, 8-9pm) –Mental health (Wednesday 13 May, 8-9pm) Breakfast Trial

CRN’s HRA Approval Readiness Plan Will support the HRA ambition to deliver HRA Approval for December 2015 whilst maintaining CRN performance Plan broadly focused around required process changes, information system changes and workforce impact with the aim to ensure that the set-up of Portfolio studies is not negatively impacted during and after HRA approval implementation Collective approach towards HRA approval readiness to avoid multiple ways of working

CRN Study Support Service

What is the CRN Study Support Service? A high quality, consistent research delivery function The NIHR CRN facilitates the development, set-up and delivery of clinical research studies in the NHS. We currently provide a range of guidance and procedures to support research delivery in the NHS We are introducing the Study Support Service to ensure greater consistency to this offering Regardless of the topic of your research, or your location, you should receive the same level of support if eligible. Not a new service but a streamlining and standardising what we already do (one CRN approach)

What is the Study Support Service programme? The CRN Study Support Service programme is providing the operational detail required to support CRN staff (both local and national) to provide a high quality, consistent research delivery function What’s in scope ? All elements of the research delivery pathway All studies until they are deemed ineligible for CRN Support Standardisation of existing processes and services Development of a national framework to support local delivery Development of new processes and services What’s out of scope? Network feasibility service offerings to the Life Sciences Industry NIHR CRN Portfolio eligibility processes for non-commercial studies

CRN Research Delivery Pathway

CRN Study Support Service route map

Study Support Service Helpdesk Launched in February 2015 Provides a central function for handling enquiries relating to all aspects of the CRN Study Support Service Accessed via Integrated the previous Industry, Portfolio and RM&G helpdesks The CSP Helpdesk will be excluded from this project due to the establishment of the Health Research Authority (HRA) Assessment and Approval, and the decommissioning of CSP SOP defines the process for managing the inbox and triaging and escalating queries

CRN Study Support Service route map

Early contact and engagement with researchers Providing advice and support for CIs and their study teams about how the NIHR CRN can support them to deliver their study to target and on time. Advice provided across all elements of the Research Delivery Pathway; including: CRN service offerings AcoRD guidance, pre-application support ad attribution of protocol activities and excess treatment costs, utilisation of costing templates Regulatory approvals and research management Recruitment pathways (subsidiary sites, continuing care sites, PICs etc) and clinical support departments (pharmacy, medical exposure, laboratories) Identifying training requirements Local intelligence (Partner organisations, local external stakeholders, PPI, clinical research specialty leads, RDMs) Predominately provided by the LCRN where the CI is geographically based Provided for multi-Trust studies only initially Supersedes the Coordinated Network Support Service (and Lead Network Service) Operational guide in development to support Local Network teams to deliver a high quality and consistent Early Contact Service Operational from July 2015

CRN Study Support Service route map

Feasibility services

Commercial Early Feedback An optional service providing expert guidance on delivery of a study in the NHS for inclusion in grant applications or protocol development Already available – no changes planned as a result of Study Support Service programme Site Identification Supporting the identification of potential study sites (expressions of interest) Already available – no changes planned as a result of Study Support Service programme Site Intelligence Compliments Sponsor feasibility by using our site and study intelligence Already available – no changes planned as a result of Study Support Service programme Non-commercial Early Feedback An optional service providing expert guidance on delivery of a study in the NHS for inclusion in grant applications or protocol development SOP in development, released for consultation in March Not to be included in phase 1 implementation of CRN Study Support Service Site Identification An optional service supporting the identification of potential study sites (expressions of interest) SOP in development, released for consultation in March Not to be included in phase 1 implementation of CRN Study Support Service

CRN Study Support Service route map

Eligibility for CRN support Non-commercial Application made via IRAS by completion of a Portfolio Application Form and then an NHS R&D Form Eligibility criteria: –Meet the DH definition of research –Have been funded through open competition and following high quality peer review –Meet the needs, priorities and realities of the NHS –Be of value to the NHS Studies are either: –‘Automatically eligible’ if funded by NIHR, an other area of Government or and NIHR non-commercial Partner; OR –‘Potentially eligible’ if funded by a commercial company (Investigator Initiated Studies), an overseas charity or an overseas government –‘Potentially eligible’ studies are required to go through the non-commercial adoption process Commercial Application made via the Industry Application Gateway Study required to meet eligibility criteria and be feasible to be eligible for CRN Support Eligibility criteria: –Meet the DH definition of research –Have applied for a REC opinion and NHS Permission –Be feasible

CRN Study Support Service route map

CRN Risk Assessment A mandatory process for non-commercial CRN studies to identify any specific challenges to study set-up and / or delivery Includes both national Coordinating Centre staff and local network staff ONLY Studies planning to open to recruitment in more than one NHS organisation (multi-site studies) SOP in development, released for consultation in March 2015 Pilot of process expected in late May early June Operational from 1 July 2015 (possibly for only a sub set of studies only initially)

CRN Study Support Service route map

Effective study set up

CRN Study Support Service route map

Our network of clinical specialty experts Development of guidance on where involvement of clinical specialty experts adds value to a CRN service offering or business process Development of a CRN wide role outline for national clinical specialty experts Development of a CRN wide induction / information pack for national clinical specialty experts

Timescales Pilots being planned for late May / early June A number of services operational from July After July 2015? –Further refinements of the services and processes implemented in July PLUS –Pilot and implementation of the Early Feedback service for non-commercial studies –Pilot and implementation of the Site Intelligence service for non-commercial studies –CRN process for overseeing follow-up activity –Sponsor engagement

Further information or questions Any questions please contact the Study Support Service Helpdesk via