nhs research scotland - overview
DESCRIPTION
NHS Research Scotland - Overview. Dr Alison Walker National Coordinator, NRS Permissions CC ([email protected]). Agenda. Background to NRS / NRS Permissions CC Feasibility service NHS R&D permissions process for Scotland NRS Metrics Progress/future plans. NHS Research Scotland. - PowerPoint PPT PresentationTRANSCRIPT
NHS Research Scotland - Overview
Dr Alison WalkerNational Coordinator,NRS Permissions CC
Agenda
• Background to NRS / NRS Permissions CC• Feasibility service• NHS R&D permissions process for Scotland• NRS Metrics• Progress/future plans
NHS Research Scotland
• Collaboration– CSO– 14 NHS Boards in Scotland
• Funding– CSO and Scottish Enterprise
• Function– coordinate R&D processes and
systems
‘..agree and implement national policy to deliver greater efficiency in the NHS R&D and Research Ethics function’
More efficient and effective service for industry CSO – Chief Scientist office
Hub & Spoke Model
Four regional hubs– NRS North (NHS Grampian)
• NRS Permissions CC
– NRS South West (NHS GG&C)• IT systems lead (SReDA)
– NRS South East (NHS Lothian)• Contracts• National training
– NRS East (NHS Tayside)• Governance
Regional arrangements deliver co-ordinated systems to facilitate clinical research
GG&C – Greater Glasgow & Clyde
NRS Permissions CC
• Dedicated administrative team• Single point of contact• Feasibility service• Coordinate study set-up• Link with other UK-coordinated systems:
– CSP Unit (England)– NISCHR PCU (Wales)– Northern Ireland Gateway
Streamlined process to obtain R&D permission for multicentre research in Scotland
NRS Permissions CC - the team
• Director– Professor David Reid
• National Co-ordinator– Dr Alison Walker
• Senior Administrators– Pamela Shand– Karen Innes
• Administrator– Lindsay Grant
NRS Permissions CC - Services
• Coordination of study start-up processes–Master CDAs–Feasibility across Scotland–R&D permissions process for multicentre1 studies
• Coordination of post-approval processes–Amendments–Addition of new sites
CDA – Confidentiality Disclosure Agreements1 ≥ one site in UK
Feasibility in ScotlandProtocol/Questionnaire
received by NRS Permissions CC
Commercial R&D Managers & Facilitators
Scottish Topic-specific Network Managers
Scottish Clinical Speciality Leads
Specialist Investigators
Collated feedback to Sponsor
Process actively managed with an aim to feedback within 2 weeks
Key Therapy Areas
•Cardiovascular Disease•Gastrointestinal Disease•Inflammation/Immunology•Neuroscience•Ophthalmology•Respiratory Disease•Tissue Research
•Dermatology•Infectious Disease•Metabolic Disease/Diabetes•Oncology•Mental Health•Stroke•Women’s Health
• Extensive imaging infrastructure and latest biomedical NMR imaging techniques• Scottish Clinical Specialty Lead represented on UKCRN/NIHR Specialty Groups• Topic-Specific Research Networks e.g. Diabetes, Mental Health, Dementia, Cancer,
Stroke, Medicines for Children, Primary Care
Coordinated R&D Permissions
Process Overview
Processes run in parallel 30 calendar days from ‘full document set’ to R&D permission
Initial approach to NRS Permissions CC
‘Full document set’ received by NRS Permissions CC
Lead Health Board Local Health Board
Certificate of Compliance
Generic Review
Management Approval
Local Review
When to submit to NRS Permissions CC
• R&D permission process in Scotland is simple, but can vary depending on:-– single- or multicentre in Scotland?– UK-wide study involving CSP, etc?– lead R&D office?
• When to submit via NRS Permissions CC– More than one Board/Trust within UK
• Regardless of adoption in England• Regardless of use of CSP, etc.
Lead R&D Office in Scotland
• NRS Permissions CC:– collates the global document set– forwards IRAS R&D Form plus global document set, promptly,
to other UK Coordinating Centres– assigns a Lead reviewer in Scotland to carry out a generic
review on behalf of the UK– forwards the Certificate of Compliance (CofC) to other UK
nations
• Scottish Boards and UK Trusts/Boards complete local reviews
UK Wide Study – Lead from Scotland
Permissions CC will confirm when we have a full document set
Applicant notifies Permissions CC of UK-wide multicentre project
Permissions CC sends applicant ‘Document Submission Checklist’
Applicant sends IRAS R&D application to Permissions CC; and IRAS SSI Forms to PIs (UK-wide)
Confidentiality Agreements as required
Permissions CC uploads documents to SReDA; notifies participating Scottish R&D office(s); requests outstanding documents; assigns lead reviewer
Generic Review Local Review(s)Scottish sites
Permissions CC emails IRAS R&D Form to other UK
nation(s)
Certificate of Compliance (CofC)
For each Scottish Health Board:Local management permission letter
Permissions CC emails CofC to other UK nation(s)
Permissions CC emails global documents to other
UK nation(s)
SSI Form
R&D Application Submission
• Email documents to [email protected] • Confirm participating Health Boards/sites• Submit prior to Ethics/MHRA approval• IRAS SSI Form sent to local Investigators (PI), for completion,
signing and submission to local R&D office
For commercially-sponsored projects:• UK CRN Industry Costing Template current version• Scottish model contract
– mCTA, mCIA, mCTA-CRO, mCIA-CRO, mRegistry/Epidemiology
Scotland’s performance
NRS Performance Metrics
Non-commercial studies: R&D permission times (Jan 10 – Dec 12)
20
1715
18
13 13
27
2422 21
18
15
0
5
10
15
20
25
30
Jan-Jun 10 Jul-Dec 10 Jan-Jun 11 Jul-Dec 11 Jan-Jun 12 Jul-Dec 12
Time period
R&D
perm
issi
on ti
me
(wor
king
day
s)
Median
Mean
Commercial Statistics
• Commercial clients to date:– 134 Pharmaceutical / Device companies– 49 Contract Research Organisations
• Total number of commercial projects : 441– 67% using only a single site in Scotland
• Feasibilities (commercial)– 224 coordinated
NRS Performance MetricsCommercial studies: R&D permission times (Jan 10 – Dec 12)
1816 16
18 18
2119 19
21 20 20
25
0
5
10
15
20
25
30
Jan-Jun 10 Jul-Dec10 Jan-Jun 11 Jul-Dec 11 Jan-Jun 12 Jul-Dec 12
Time period
R&D
perm
issi
on ti
me
(wor
king
day
s)
Median
Mean
Commercial Feedback
• “Time to approval accurate and simple advice on how to submit; R&D accepted NIHR budget with no questions (a very refreshing change!). Very quick, straightforward and reliable (it’s the submission I don’t have to worry about!). ”
• “Process was smooth from start to finish. Scottish site was first site to be granted R&D approval, 7 days before second R&D approval at English site.”
• “R&D communication and approval process. Excellent, in fact, encouraging to Sponsors to perform more studies in Scotland.”
No. of replies = 84 Unacceptable Poor Acceptable Good ExcellentAvailability ofNRS PCC personnel?
4
34 44
Competence ofNRS PCC personnel?
1 4 36 41
Helpfulness/attitude/flexibility of NRS PCC?
1
26 54
Overall experience? 1 6 35 41
Progress and moving forward
Progress to date
• Consistent R&D permission times• Single commercial price for Scotland• Patient Recruitment
– Management systems to monitor recruitment– SHARE – patient database
• Re-branding• Website (www.nhsresearchscotland.org.uk)
– Board capability statements• Engagement with Industry
– NHS/Industry partnership forum– Visits and presentations
Moving forward
• Engagement– Industry Liaison Manager
• Health informatics– Safe havens
• Website development– Enhanced capability statements– Commonly requested documents
• Lab certificates• CVs ??• Commercial prices
• Recruitment– Active management
Supporting Studies Locally
• Commercial Facilitators– 2 in each node (primary and secondary care)– Assist with feasibility, start up and recruitment
• Nurses– Dedicated research nurses– Expert support for investigators
• Imaging infrastructure– Dedicated scanners and reporting
Contact Details
Dr Alison WalkerNational Coordinator
NHS Research Scotland Permissions Coordinating Centre(NRS Permissions CC)
[email protected]: 01224 554051
NRS Permissions CC Office [email protected]
Tel: 01224 552690
Website: www.nhsresearchscotland.org.uk/NRSPCC
