The Northern Ireland Clinical Research Network. Guidance Document

The Northern Ireland Clinical Research Network Guidance Document Document Page NICRN Steering Committee Terms of Reference 2 NICRN Clinical Management Group Terms of Reference 4 NICRN Clinical Lead Role Description 8 Appointment of Clinical Lead posts 10 NICRN Annual Report template 11 Proposal for the establishment of a NICRN Clinical Speciality Group template 12 Memorandum of Understanding (MoU) - HSC Trusts and NICRN 13 NICRN Adoption Process Guidance 16 1 P a g e

Background to NICRN Steering Committee Terms of Reference HSC Research and Development Division provide core funding to support the N. Ireland Clinical Research Network (NICRN). NICRN provides infrastructure that allows high-quality clinical research to take place across all Health and Social Care (HSC) structures, so that patients can benefit from new and better treatments. The Network provides skilled health professionals who can help researchers to set up and run clinical studies quickly and effectively and work with patients and the public to ensure their needs are at the centre of research activity. The NICRN aims to: Enhance the ability of patients and health care professionals to participate in and benefit from clinical research Enhance the quality of clinical research undertaken within HSC Improve the speed of delivering research outcomes Enhance the regional coordination of clinical research across Trusts and academic organisations Improve integration of clinical research within HSC structures and services The NICRN is made up of different Clinical Specialities (Interest Groups) working in areas that are relevant to the HSC. These are led by clinicians with a proven track record in clinical research. The Clinical Speciality Groups are facilitated by research support posts in the HSC, so that researchers have access to experienced staff, who can carry out the research study and for example, obtain participant consent, carry out extra participant tests, and collect the clinical data required for the research. The Network also provides help to identify and recruit patients onto research studies, so that researchers can be confident of completing the study on time, and on target. Aim of the Steering Committee The aim of the NICRN steering committee is to oversee all aspects of NICRN activity. Terms of reference 1. To provide strategic advice and ensure that NICRN develops in line with the objectives established by the HSC R&D Division. 2. To review NICRN activity across clinical specialities and HSC Trusts and to monitor trends. 3. To review the balance of NICRN activity between academic and industry sponsored studies. 4. To review NICRN performance through a range of agreed quality reporting measures. 2 P a g e

5. To review the NICRN expenditure and the infrastructure provided by NICRN to ensure that it can deliver the objectives established by the HSC R&D Division. 6. To advise on appropriate support across different clinical specialities. i.e. agree and support the existing NICRN Clinical Speciality Groups; the development of new groups and the removal of under-performing groups. 7. To review and ensure constructive collaboration between NICRN and academic researchers and academic research institutions to support clinical research. 8. To review and ensure constructive collaboration between NICRN and HSC organisations to support clinical research. 9. To review and ensure constructive collaboration between NICRN and both the pharmaceutical industry and clinical research organisations to support industry sponsored research. 10. Ensure collaborative working with the NI Cancer Trials Network 11. To advise on the engagement of NICRN with other relevant external organisations 12. To ensure that there is appropriate Personal and Public Involvement (PPI) in NICRN activities and decision making. Potential Membership NICRN Clinical Director [Chair] NICRN Senior Manager Representative of NICRN Clinical Speciality Group leads NI Cancer Trials Network Director NI Cancer Trials Network Senior Manager Assistant Director HSC R&D Division PVC Research (Queen s University Belfast) PVC Research (Ulster University) Representative(s) of HSC Trust Research Offices (Research Director and/or Research Manager) PPI representative(s) Nominee of ABPI 3 P a g e

Clinical Management Groups - Terms of Reference 1.1 CONSITIUTION As part of the Northern Ireland Clinical Research Network (NICRN), Clinical Management Groups (CMGs) will be established to support each NICRN Clinical Speciality Group (Interest Group) CMGs will help manage the adoption and on-going monitoring of the Clinical Speciality Group s clinical research portfolio, staff and outcomes. The CMG will also provide a structure which can work with the NICRN Director and NICRN Senior Management Team 1 to define the group s strategic direction and communications. CMGs will include representation from pertinent research active organisations across Northern Ireland including researchers and clinicians and other appropriate research active staff with local/national skills and knowledge, as well as NICRN core funded staff from the Clinical Speciality Group and Personal and Public Involvement (PPI) representative(s) as appropriate. 1.2 AUTHORITY Each CMG will be overseen by a NICRN Clinical Lead role. The Clinical Lead will be expected to carry out local and national role responsibilities. To facilitate this, the Clinical Lead role will be a funded position and each Clinical Speciality Group will be allocated 2 PA s from core funding. It is recommended where possible, that the Clinical Lead role is shared between two leading researchers/clinicians (1 PA each). The NICRN Clinical Speciality Group CMGs will report to the NICRN Director and NICRN Senior Management Team through the Clinical Lead(s). Clinical Lead(s) will be appointed by a competitive process. 1.3 REMIT Broadly, the role of the Clinical Management Groups is to provide expert input to the development of R&D in NI (across the HSC) in a given clinical speciality. More specifically, the groups aim is to: Provide a NI focus for research activity in a particular clinical speciality. Provide a forum where all researchers with an interest in the clinical speciality can come together to discuss and develop the local (NI) capabilities and research portfolio in that area. Inform the deployment of NICRN staff to support clinical research in the specialty through research study adoption (see below). 1 The NICRN Senior Management Team is part of the NICRN Co-ordinating Centre (CC) 4 P a g e

Review all proposed clinical trials and other high quality studies in the clinical speciality and provide an informed decision on local adoption (as per NICRN adoption and prioritisation guidance). Work to identify local opportunities and priorities for participation in multi-centre portfolio studies. Also to identify those local studies which would benefit from being opened up to additional sites nationally. Provide a skilled/knowledgeable platform for the discussion of all aspects of the Clinical Specialities Group s portfolio including a consideration of constraints imposed by feasibility and infrastructure. The CMG will work closely with local or national specialty groups and the NICRN senior management team / NICRN Director to resolve any difficulties that might impact on study delivery. Monitor, review and troubleshoot the studies on the local portfolio to ensure recruitment is being delivered to time and target. The CMG lead(s) will inform the NICRN Senior Management Team / Director in a timely manner of any risks or challenges in the successful delivery of a study. Support commercial studies in liaison with appropriate NI structures and raise awareness of working with industry and developing a commercial studies portfolio. The CMG lead(s) in liaison both with CMG members and regional researchers provide in timely manner feasibility information required for commercially sponsored studies; this information might include identifying potential study sites/investigators, assessing the available research resources including skills, facilities and equipment and providing anticipated patient numbers. Liaise with other NICRN Clinical Speciality Groups as appropriate in the adoption and delivery of clinical research studies. 1.4 MEMBERSHIP The Clinical Lead(s) is/are responsible for inviting appropriate membership to the CMG to support the CMG in achieving its objectives. Where appropriate the NICRN Director / Manager may make suggestions regarding CMG membership to ensure that it can best achieve its objectives. The Clinical Lead(s) should provide opportunities for Expressions of Interest for interested parties to become CMG members. All members of the CMG are entitled to be present at all Clinical Speciality Group Meetings. The Group may invite non-members to attend to inform its meeting as it considers necessary. The Clinical Lead(s) will provide a list of CMG members (updated as necessary) and attendance of members at meetings to the NICRN senior management team. Membership of the CMG should, where possible have representation from the following groups: clinical and academic personnel from the HSC Trusts and/or primary care; the NI Universities; other 5 P a g e

local/national stakeholders such as charity bodies; and patient and public representatives. All members should be chosen on the basis that they bring knowledge and expertise which will support the CMG in achieving its objectives. The CMG must be able to demonstrate appropriate Personal and Public Involvement (PPI) in the decision making process but there is no mandated approach to PPI and CMGs are free to choose the most appropriate way to involve patients, carers and the public. NICRN core funded staff allocated to and supporting studies in the Clinical Speciality Group will be members of the CMG. Where possible, one or more members of the NICRN coordinating centre senior management team will be in attendance at CMG meetings, with the primary role of informing the group s decision making process by providing the relevant data around staff capacity, study metrics, portfolio, and adoption. As such they will not have voting rights in relation to adoption. 1.5 MEETINGS and QUORACY Meetings should take place 3-4 times per year as per direction of the Clinical Leads. Responsibility for scheduling meetings will rest with the Clinical Lead(s), with administrative support from the NICRN Co-ordinating Centre (CC). These meetings should be booked well in advance (a minimum of 8 weeks notice is required) to facilitate clinical attendance; teleconference/video conference will be arranged where available. To facilitate participation from all Trust localities, consideration should be given to rotating the venue for the CMG across all active sites. To facilitate the efficient working of the CMG, the NICRN senior management team should hold pre- CMG meetings with the Clinical Lead(s) to ensure all aspects around the proposed agenda staffing, adoption and study metrics are discussed prior to the CMG. To be quorate more than half of the CMG voting members must be in attendance. If the meeting is not quorate, the Clinical Lead(s) will cascade relevant information electronically to support decisions. In the event that, following electronic cascade of proposals to the CMG, the requested quorate responses If the number of responses to the latter (within 5 working days) falls below that necessary for quorum then the clinical lead(s).may take chairperson s actions in relation to any agenda items. Agenda for meetings are drafted by the Clinical lead(s) and should be circulated a minimum of 1 week before the agreed meeting dates. Draft minutes (to be approved at the subsequent meeting) of each CMG meeting should be circulated to CMG members within a fortnight of the meetings. (NICRN Co-ordinating Centre will provide administrative support for minute taking see below) 6 P a g e

Draft CMG minutes (including the attendance record) must be provided to the NICRN senior manager within two weeks of the CMG meeting. These may be circulated to HSC Trust Research Managers / Research Directors minutes for information. Draft minutes may also be shared as appropriate with wider HSC stakeholder. If a member has not attended or provided apologies for 1 year (i.e. 3 or 4 meetings) then the Clinical Lead should engage directly to discuss the member s continued involvement and seek an appropriate replacement. 1.6 NICRN COORDINATING CENTRE ROLE The NICRN Director and Senior Management Team will work with the Clinical Lead(s) and the CMG regarding monitoring for the Clinical Speciality Group activity. The NICRN co-ordinating centre (CC) will support the Clinical Lead(s) and the CMG, by providing up to date data on staff capacity, portfolio and adoption activity, quality performance, measures. The NICRN CC will provide administrative support to the Clinical Lead(s) and the CMG (either from within the CC team or via a dedicated administrative resource for the Clinical Speciality Group). The NICRN Senior Management team will hold regular meetings (ordinarily 6 monthly) with the Clinical Lead(s) to review Clinical Speciality Group activity and to support the CMG in achieving its objectives. These meetings will inform the strategic development and planning cycle of NICRN. The NICRN CC can facilitate the booking of travel and possibly accommodation for Clinical Leads to attend national Clinical Speciality Group meetings. Subsistence costs for attendance can be remunerated via CC. The NICRN CC will submit an annual report to the PHA R&D Division on the totality of NICRN activity and will including information on each of the Clinical Speciality Groups. This report may in whole or part be shared with external stakeholders. Date Adopted 7 P a g e

NICRN Clinical Lead role description Clinical Lead(s) will be appointed for a 3 year period with the possibility of extension of up to three years as agreed with the NICRN Director. Extensions beyond a second three year term may be considered in exceptional circumstances by the NICRN Director. The Clinical Lead(s) should gain an understanding of the research being undertaken in their speciality across the NI research environment. This may involve developing communication links with as many relevant investigators/stakeholders based within their clinical speciality as possible. Clinical Leads should make themselves available for meetings of local investigators to promote a collaborative approach to research across the NI stakeholder organisations. It is the responsibility of the Clinical Lead(s) to chair all CMG meetings and work closely with the NICRN senior management team to contribute to the performance management of the CMG objectives over the annual planning cycle 2. The Clinical Lead(s) should contribute to decisions on resource allocation across the Clinical Speciality Group and ensure that funding is being used strategically and for the purposes intended. They should work with their local investigators and the CMG members to agree the adoption of relevant clinical research studies within their speciality and realistic targets for recruitment to these studies and ensure that the infrastructure is in place to support this. The Clinical Lead(s) should work with Chief Investigators (CIs) and Principal Investigators (PIs) of studies based in their clinical specialty, emphasising the importance of keeping their study information on the portfolio database accurate and up to date and regularly reporting recruitment data; signposting them to sources of support available from the NICRN CC. The Clinical Lead(s), working with the NICRN CC and their local CIs and PIs, should identify studies which are failing to meet their recruitment targets, identify the reasons for this and help to resolve local blockages and barriers to recruitment. Issues of a generic nature should be brought to the national meetings of the Speciality Group for discussion and resolution. The Clinical Lead should promote growth in the local portfolio by identifying local opportunities, e.g. unmet capacity and capability, and matching these with opportunities for joining multicentre studies. In addition, locally led studies which are open to new recruitment sites should be identified and brought to the attention of the national Speciality Group. The Clinical Lead(s) should lead on the local implementation of actions to support national initiatives agreed by the national Speciality Group, e.g. mapping exercises of local expertise and capacity. The Clinical Lead(s), working with the NICRN CC, should provide contacts with relevant PIs within the region and develop and maintain an understanding of the local infrastructure for supporting commercial studies. 2 The NICRN co-ordinating centre (CC) will support the Clinical Lead and the CMG, by informing the group regarding up to date data on staff capacity, study metrics, portfolio, and adoption, as well as providing administrative support. 8 P a g e

The Clinical Lead(s), working with the NICRN CC, should contribute to raising awareness of the importance of working with industry, meeting with relevant local/national/international stakeholders to promote the industry agenda and NI capabilities. Clinical Leads may also wish to take the lead in developing and bringing together groups of local researchers to discuss, and develop, grand proposals to develop their local research portfolio. The Clinical Lead(s) should be members of the National Speciality Groups and are expected to attend national Speciality Group meetings, either face to face or by teleconference (minimum attendance is 2 meetings a year out of 3, deputies can attend under exceptional circumstances) 3. It is essential that the national Speciality Groups have oversight of the resources which local NI CMG s are providing to support studies in their/national portfolio, and for NI members to provide the groups with an update of local activity, issues and examples of impact and good practice 4. Clinical Lead(s) should share local issues with the national Speciality Groups to promote an awareness of blockages/barriers to research in the speciality with a view to finding resolutions. Clinical Leads should also share example of local arrangements which are working well in order to promote best practice nationally and across the NICRN Clinical Speciality Groups. Clinical Lead(s) should contribute to national initiatives being taken forward by the national Speciality Group, e.g. the development of communications material, or good practice guides. Where the portfolio of the national Speciality Group is significant, members might also be expect to take a leadership role for the part of the portfolio of the national group, or for some specific studies. The Clinical Lead(s) should contribute to raising awareness and an understanding of the NICRN and its support systems with the researchers within their speciality. They will be required to produce sections for the NICRN annual report and will have an opportunity to feed into the business planning process for the forthcoming year. 3 Travel and possibly accommodation can be booked via the NICRN CC and subsistence costs for attendance can be remunerated via the CC. 4 The NICRN CC can complete and submit a NI regional report (using a template agreed between the NICRN portfolio manager and the appropriate contact within national group) to the National Coordinating Centre prior to every national Speciality Group meeting (regardless of whether or not the Clinical Lead is attending). 9 P a g e

Appointment of Clinical Lead posts to NICRN Clinical Specialty Groups (Interest Groups) Background The Northern Ireland Clinical Research Network (NICRN) operates via a number of thematic, disease specific interest groups (Clinical Specialty Groups). These groups were established with appropriate resource following successful review of a proposal submitted to HSC R&D Division. The groups are monitored on an ongoing basis to ensure that the resource is being effectively managed. Each Clinical Specialty operates via a Clinical Management Group (CMG). CMGs are led by Clinical Leads who provide leadership on all aspects of group and are expected to carry out local and national role responsibilities. The CMGs report to the NICRN Director and NICRN Senior Management Team through the Clinical Lead(s). The Clinical Lead role is a funded position and each Clinical Speciality Group is allocated 2 PA s from core funding. It is recommended where possible, that the Clinical Lead role is shared between two leading researchers/clinicians (i.e. 1 PA each). Process for appointing Clinical Leads Clinical Lead(s) will be appointed by a competitive process. The NICRN Coordinating Centre (CC) will ensure that an Expression of Interest (EoI) for a Clinical Lead position is circulated to members of the CMG, active PIs within the Clinical Specialty, and wider interested parties including research interested clinical staff and academics. The Clinical Lead role description will be made available. Positions may also be advertised on the NICRN and HSC R&D Division websites In most cases interested parties will be requested to submit a 1 page CV and 500 word summary outlining their suitability and vision for the role. Shortlisting and interview(s) will be undertaken by the NICRN Director, NICRN Senior Manager, representation from HSC R&D Division and representation from existing NICRN Clinical Leads. The NICRN Director may also appoint other suitable representation to this decision-making panel. Clinical Leads roles are undertaken within the existing employment arrangements of staff. Therefore persons offered the Clinical Lead role will seek agreement from their employer before taking up the role and these arrangements will be approved by the NICRN Director. NICRN CC and HSC R&D Division will confirm the arrangements for payment with the employing organization. 10 P a g e

NICRN Annual Report - template 1. Executive summary of achievements / challenges in reporting year 2. Major developments in reporting year 3. Staffing Total staffing broken down by Interest Group and HSC Trust base [Table 1] Brief commentary on change since previous year. Clinical Specialty Group Clinical Leads [list in Appendix 1] 4. Staff training events [list in Appendix 2] Brief commentary. 5. Activity [No of open studies / adopted studies] compared with previous 3 years activity for each HSC Trust/primary care [Table 2] activity for each interest group [Table 3] Brief commentary on activity and changes / trends. 6. Activity [No of patients screened / accrued] compared with previous 3 years activity for each HSC Trust / primary care [Table 4] activity for each interest group [Table 5] Brief commentary on changes / trends. 7. % recruitment target achieved compared with previous 3 years breakdown by interest group [Table 6] breakdown by HSC Trust / primary care [Table 7] Brief commentary on changes / trends 8. Portfolio breakdown commercially sponsored v non-commercially sponsored [expressed as % and compared to previous 3 years] breakdown by interest group [Table 8] Brief commentary on changes / trends 9. Portfolio breakdown by RCT v non RCT sponsored and by Interventional v Observational [expressed as % and compared to previous 3 years] breakdown by interest group [Table 9] Brief commentary on changes / trends. 10. Time from set-up to first patient visit [commercial studies only] breakdown by interest group [Table 10] breakdown by HSC Trust / primary care [Table 11] Brief commentary on changes / trends. 11. NICRN steering committee 12. PPI engagement 11 P a g e

A proposal for the establishment of a: Northern Ireland Clinical Research Network Clinical Speciality Group Background This document describes the content to be included in a proposal for the establishment of a new Northern Ireland Clinical Research Network Clinical Specialty Group (Interest Group). The proposal document should make the case why a new Clinical Specialty Group is needed, how this aligns with local and national strategic developments, demonstrate local research expertise and capability and indicate a pipeline of UK CRN or other studies that might be adopted. Wherever possible the proposal should involve more than one HSC Trust and where this is not possible the author(s) should justify the single Trust proposal. Contents of the proposal document Authors (inc. corresponding author) List of Contributors Executive Summary Background to the Clinical Speciality patient/client priorities and burden alignment of proposal with DoH strategic priorities alignment of proposal with regional / national research priorities Current Research Activity in the Clinical Speciality demonstrate track record in research list current research activity in Northern Ireland (appendix) list research funding and personnel (appendix) list relevant research publications (appendix) Proposal for NICRN Interest Group research ethos and strategy o Involvement at UK and local level including evidence of collaboration and wider stakeholder engagement/support o Research priorities for group implementation and management plan o Who, where, when, how etc. proposed portfolio o Potential UKCRN studies that could be adopted by NICRN (Clinical Speciality) outline budget Conclusions Letters of Support 12 P a g e

Memorandum of Understanding (MoU) between the Northern Ireland Clinical Research Network (NICRN) Coordinating Centre and the Health and Social Care Trusts (HSC trusts). 1. Parties with an interest in this MoU a. Northern Ireland Clinical Research Network (NICRN) b. Health and Social Care Trusts (HSC Trusts) c. HSC Research and Development Division, Public Health Agency (HSC R&D) d. Northern Ireland Cancer Trials Network (NICTN) 2. The NICRN was established by HSC R&D to support network adopted clinical research within Health and Social Care (HSC) organisations and to facilitate the conduct of network adopted trials to the highest national and international standards. 3. The NICRN currently comprises regional Clinical Speciality Groups (Interest Groups): Cardiovascular disease, Children s, Critical Care, Dementia, Diabetes, Gastro-intestinal, Mental Health, Renal, Respiratory Health, Stroke, Vision and Primary Care. Each Clinical Speciality is led by prominent clinicians with an appropriate track record in clinical research. Clinician time to act as clinical speciality lead is supported by 2PA s per interest group. This is used either to support a single clinician or more commonly shared between 2 clinicians (1PA each). In addition to the clinical leads, the NICRN provides a network of skilled support staff to enable the delivery of high quality network adopted clinical research studies across all Health and Social Care (HSC) structures 4. The NICRN Coordinating Centre (NICRN CC) oversees the delivery of the NICRN activity by supporting the Clinical Speciality Groups, the NICRN staff and the clinical research community in Northern Ireland. The NICRN CC is made up of a senior manager, a professional staff manager, a portfolio manager, an adoptions co-ordinator and administrative staff. 5. The purpose of this MoU is to enable effective working relationships between the NICRN CC and the HSC Trusts. The NICRN CC relies on a partnership approach with the HSC Trust in order to manage effectively NICRN support staff employed by HSC Trusts as well as manage the portfolio of NICRN network adopted studies that are open or in set up in the HSC Trusts. 6. Management of NICRN support staff employed by HSC Trusts a. The NICRN CC senior manager and staff manager will have honorary contracts or placement agreement with the HSC Trusts (where required) in order that they may manage effectively HSC Trust deployed NICRN support staff. The NICRN CC Senior manager and Professional staff manager will work collaboratively with the HSC Trust Director of Research & Development, Research Manager and Trust Line Managers. NICRN CC will request a named HSC Trust line manager for each NICRN staff member employed by the HSC Trust. It is recognised that the NICRN staff are employed by the HSC Trust but are funded by and undertake duties in supporting research activity as part of NICRN. NICRN staff members therefore have both local HSC Trust and NICRN responsibilities. b. The NICRN CC professional staff manager will liaise and work collaboratively with the HSC Trusts Line manager on the operational and professional management of HSC Trust (NICRN funded) Staff. The following table outlines the roles undertaken by the NICRN CC professional staff manager and the HSC Trusts Line managers in managing the NICRN staff: 13 P a g e

Lead management NICRN CC professional staff manager NICRN CC professional staff manager (in liaison with the HSC Trust line manager) HSC Trust Line manager (in liaison with the NICRN CC Professional staff manager) Management role of NICRN staff i. NICRN staff induction ii. Day to day management including deployment to work on NICRN adopted research studies iii. Study portfolio management through assessment of current trial activity/intensity and capacity of studies supported by NICRN staff iv. Identification of training needs (in conjunction with Trust Line Managers) v. Participation in NICRN audit i. Professional supervision in respect of NICRN role ii. Appraisal in respect of NICRN role i. Professional Registration, Appraisal & KSF review ii. Professional supervision iii. HSC Trust induction & on-going Mandatory training iv. Management of leave requests v. Participation in HSC Trust audit vi. Communication of Trust updates, policy and procedures vii. Disciplinary processes in line with HSC Trust procedures viii. Approval of expenses 7. Recruitment & Selection of NICRN staff a. To ensure uniformity across NICRN, a standard NICRN nurse core job description will be developed and used for all newly advertised NICRN posts. b. The HSC Trust Line manager and HSC Trust Research Office, working closely with NICRN CC, will organise the recruitment and selection process for new NICRN support staff. The NICRN CC will request the inclusion of the NICRN professional staff manager within the recruitment and selection process in line with local HSC Trust HR procedures. 8. Movement of NICRN staff It is expected that NICRN staff employed by HSC Trust will in the main support NICRN network adopted studies within that HSC Trust. There may be occasions when there is a mismatch between activity and NICRN staff resource within a given HSC Trust e.g. due to staff absence or due an upturn or downturn in NICRN trial activity. Where possible cross cover will take place within the HSC Trust NICRN staff team. However in certain circumstances taking into account the needs of active patient participants in research studies and the NICRN study portfolio as a whole it may be beneficial for individual NICRN staff to be deployed in another HSC Trust to support NICRN network adopted work. 14 P a g e

This will only happen with direct consultation between the NICRN CC professional staff manager and the relevant HSC Trust Director of Research & Development / Research Manager. 9. Study/portfolio Management The NICRN CC will: a. Determine the resources and scheduling required for each NICRN network adopted study. b. Advise Research Managers in HSC Trusts of the date and details of studies adopted by the Networks. c. Ensure an appropriate level of staffing resource is deployed at each site to meet the needs and requirements of the local NICRN portfolio. d. Ensure good communication with the local HSC Trust Research Offices. This will include the circulation of clinical management group minutes/portfolio reports. NICRN CC will inform the Trust Director of Research and Development / Research Manager of studies not achieving expected recruitment targets. e. Provide local training and guidance on data collection practices and quality assurance for NICRN adopted studies. f. Where appropriate, assist the HSC Trust Research office with study set up and facilitate information sharing. g. Support the HSC Trust Research Governance process by providing timely and appropriate records of study adoption and assist in the provision of other relevant information e.g. Protocol Impact Assessment Forms (PIAF) or alternative as necessary. h. Ensure that effective communication processes and pathways are operational between NICRN CC and HSC Trust Research Offices. The HSC Trust Research Office and/or NICRN funded HSC Trust staff will as appropriate: a. Facilitate HSC Trust research governance approval for NICRN network adopted studies. b. Assist the NICRN CC with study set up and facilitate information sharing. c. Facilitate cost recovery for NICRN network adopted studies (in liaison with the NICRN CC and HSC Trust Finance). HSC Trust: HSC Trust Director of Research: Signature: Date: NICRN Director: Signature: Date: 15 P a g e

NICRN Adoption Process Guidance This guidance is to provide direction on the NICRN adoption process to all Proposers. Expression of Interest If a Proposer is interested in firstly receiving an expression of interest from the relevant interest group before proceeding with the formal adoption of their study, NICRN is willing to give a basic review and opinion of the proposed study. NICRN will need to receive a study proposal, protocol synopsis or other brief document describing the proposed research for review. They would also need to be provided an estimate of possible support requests. The documentation will be forwarded to the members of the relevant Interest Group for review and comment. Their comments will take into account: Is study compatible with UK/NI practice Potential future benefits for NHS patients The availability and anticipated interest of collaborating NI-based investigators the prevalence of the target patient population Does NICRN have capacity to provide requested staff resources to deliver the trial data reliably and on time NICRN will return comments and initial recommendations to the proposer within two weeks of receipt of the initial request. Adoption The NICRN study adoption process is designed to work in parallel with the study R&D and Ethics applications so as not to increase approval timelines. If a proposer wishes to apply to NICRN to have their study added to the Portfolio, the following documents must be completed and submitted: NICRN Proposal Form Protocol IRAS R&D form (pdf) IRSA SSI form for each site requesting support (pdf) The NICRN Coordinator reviews submission and validates application. The application will be considered valid if all requested documents have been completed in full and submitted. If it is invalid, the Proposer will be notified and the relevant information will be requested. Once an application is valid, the NICRN Coordinator populates NICRN Adoption Summary form with relevant details from submitted forms. The CRF Intensity Tool will be used by the NICRN Coordinating Centre team to confirm the resource request. The funding of the study will be reviewed by the NICRN Senior Manager and Director. The documentation is submitted to the CMG for review. The decision to adopt a study will be based on consideration of the following: Is there a genuine and testable hypothesis or valid research question with a possible future benefit for patients as its objective? Is there a statistically valid trial design which is reasonable for the stated main objective and main hypothesis of the trial? Have the trial and its design been subject to an adequate protocol review process? 16 P a g e

Is the study compatible with current UK/NI practice? What is the level of prioritisation based on NICRN criteria? Is the study suitably funded? What are potential future benefits for NHS patients? Is there sufficient investigator interest? Are there sufficient patient numbers? Does the NICRN infrastructure have the current capacity to provide requested staff resources to deliver the trial data reliably and on time? Are there conflicting studies within the current Portfolio or higher priority studies pending? The NICRN Coordinator informs the Proposer and relevant R&D office(s) of the decision. If adoption is agreed, the status of the study remains pending NHS permission until R&D sends a copy of the Permissions letter to NICRN. The study will then be added to the NICRN Portfolio database and the status changed to Open. Once the study is open, the NICRN Coordinating Centre and Investigator will continue to work in partnership to: Agree study milestone schedule and have regular reviews Keep the NICRN Portfolio up to date with screening and recruitment numbers Acknowledge NICRN support Inform NICRN about study results. What NICRN expect in return Regular review of study milestone schedule After adoption, NICRN agree a study milestone schedule with the PI to help us plan NICRN resources that we have agreed to commit. Researchers need to make time to talk to our Coordinators every few months to ensure the milestone schedule is kept up to date to enable us to deliver the support you need. Keeping the NICRN Portfolio up to date Research teams we support must provide and update information about their studies for the NICRN Portfolio Database. This includes a summary of your project, information about the study design, the organisation that is funding the research and contact details. Our Coordinators can help you input the necessary information about your study onto the Portfolio Database. You must also supply information about the numbers of people recruited, usually once a month. Acknowledging NICRN support We also expect you to acknowledge NICRN support on any material you produce about your study, including information for participants, websites and papers published in academic journals. We encourage research teams to use plain English in all material they produce to make sure it is accessible to as many people as possible. Tell us about your results We expect you to tell us about the results of your research at the end of your study. We think it is best practice to notify professionals working in services that have supported your research about your findings. We may also be able to help disseminate your results to a wider audience, and encourage research teams to tell participants about the conclusions of the study, wherever possible. 17 P a g e

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