1. How to get support with clinical research studies
Clinical Research Network
East Midlands
How to get support with clinical research studies
Chris Siewierski, Study Support Manager – Mental Health, Community and Independent Providers of NHS Services
Ruth Robinson, Study Support Service Facilitator, Mental Health, Community and Independent Providers of NHS Services
CRN East Midlands RR
University of Leicester
Venue: George Davies Centre, University Road, Leicester, LE1 7RH
19th March 2018

2. Core elements of the service
The Early Contact Service
The Early Contact Service is the first stop on the Research Delivery pathway in the Study Support Service. It provides advice, support and direction for Chief Investigators, Sponsors, and their study teams about how the NIHR CRN can support them to deliver their study to Time and Target.
Early Feedback Service and Site Identification Service
Gathering intelligence within the East Midlands relating to participant recruitment, potential participating sites and support available
Study Delivery Assessment (non commercial) / Site Intelligence (commercial)
An assessment for all portfolio studies, undertaken by the network for the network. The outcome of this assessment is to identify challenges to study delivery.
Effective Study Start-Up Plan
Recommendations to overcome challenges identified earlier on in the research pathway
Performance Monitoring
Monitors the impact of the recommendations on study recruitment and delivery. Identifies studies requiring additional support to maintain delivery to Time and Target. CS

3. What is the CRN Study Support Service?
The CRN Study Support Service supports researchers from the research idea stage, through the whole research delivery pathway, up until study closure
This is not a new service - but streamlining what we already do nationally and locally
The service is being implemented across England in all Local Clinical Research Networks (LCRNs) to ensure greater consistency to researchers
Regardless of the topic of research or location, researchers will receive the same level of support RR

4. Early Contact and EngagementCS

5. How do we engage with researchers?
Research Idea Stage
Study Development and Planning
Face to Face meetings (when possible) to discuss their idea or proposal
Working in collaboration with the Research Design Service, CLAHRC, Clinical Trials Units, NHS Research and Innovation (R&I), academic institutions, non-NHS stakeholders, Public Health and community pharmacies
Creation and coordination of the study record management
Initial advice and guidance on undertaking clinical research within the NHS and what the Study Support Service is
Attribution of costs according to AcoRD Guidance
Delivering AcoRD training to researchers and study teams
Discussions on NIHR Portfolio eligibility criteria and process
Issuing Letters of Support as the Lead LCRN to include in funding application
Face to Face meetings (when possible) to discuss their study
Continued guidance on the Study Support Service and how your research can be delivered in the NHS
Continue to work in collaboration with all NHS and non-NHS partners
Discussions and support on NIHR Portfolio eligibility criteria and process
Gathering intelligence within the East Midlands relating to participant recruitment, potential participating sites and what support is available for the study
Support with the IRAS application for HRA Approval
National coordination of study as the Lead LCRN to all participating Local CRNs and Devolved Nations CS

6. How can Early Contact assist?
Common barriers:
Researcher has limited time to attribute costs before funding submission
Treatment Costs and/or Excess Treatment Costs have not been identified early enough
IRAS application submitted to HRA before Portfolio Adoption Form (PAF)
Solutions:
Researcher/Sponsor/Partner Organisation contacting the Study Support Service ASAP...it is never too early!
Meeting and discussion what the Early Contact Service can offer CS

7. Study Set-up and Start-upRR

8. Purpose of Effective Study Start-Up
Effective Study Start Up pulls together all previously identified study challenges into a single, study-wide action plan detailing recommendations to overcome them and support study delivery to time and target.
Consists of:
Study Milestone Schedule - a central list of all the sites participating in the study, with key study milestones and targets where applicable. Minimum requirement of the start up plan and uploaded onto CPMS by the Lead CRN
Study recommendations - specific to the study, outline the tools to be used to help set up the study at each site to maximise study delivery to time and target. RR

9. How can Effective Start-up assist?
Determines study complexity.
Identifies population required.
Specifies expertise, equipment & facilities required.
Provides explicit timelines.
Discussion with other participating LCRNs if multi-site. RR

10. Actively Optimising performance to recruit to time and targetCS

11. Managing Study Performance
All studies, commercial and non-commercial
It applies to study-level performance management
Local CRNs should continue to manage site level performance according to local processes
Performance management approach is determined by the study delivery rating assigned following National Study Delivery Assessment
3 study delivery ratings:
– Standard
– Enhanced
– Bespoke
Provides:
Clearly defined roles and responsibilities for reviewing performance;
Standard review procedures and timescales.
Communication and escalation processes to avoid duplication of activity, and promote sharing of information CS

12. How can Performance Management assist?
What barriers you may encounter whilst recruiting to time and target?
Commercial
Early Closure
Competing studies
Failed Nationally
Delays in setting up the study
Failed to deliver where other sites achieved
Difficult to recruit to and sites closed early
Data discrepancies
Investigator left
Poor study design
Non-Commercial
Capacity issues
Target set too high
Recruitment not uploaded
Incorrect data from sites, admin error and narrowly missed target
Coordinating Centre data discrepancies RR

13. Study Support Service solutions:
Examples:
Capacity issues
Research Support Team provided a research nurse for fixed term period
Recruitment was not uploaded
Portfolio Support Team provided support in upload training
Target set too high
Research Delivery Manager suggested opening other sites or PIC sites
CRN Support
Infrastructure, Service Support Costs, Inclusion/ Exclusion criteria, Training (AcoRD and Costing Template Workshops) CS
FOAM Trial:
Capacity issues, Alison gave a Research Nurse for fixed-term 12 months. Took 6 months for study to get set-up 
4D Flow MR Angiography of Abdominal Aortic Aneurysms: Was showing no recruitment. Picked up by portfolio support team during performance management. Upload issues. Provided support in upload training and target met. 
Mechanisms underlying physiology and pathophysiology of pregnancy​ ​​Too high a target​. CRN communicated that recruitment is dependent on consent not blood samples conducted or other study activities. Suggested ​open​ing study​ at other sites or ​have PICS.

14. Useful Contacts The Study Support Service email address is:
Primary Care research - East Midlands wide:
Catherine Ashman-Lee – (MAT leave)
Marie Warrington –
Andrew Skeggs –
Mental Health and Community Healthcare Services Research - East Midlands wide:
Chris Siewierski -
Acute and Teaching Hospitals Research:
Kiran Mistry – CS

15. Thank you for listening We are happy to answer your questionsCS