Transcript NRS PCC presentation

NHS Research Scotland - Overview
Dr Alison Walker
National Coordinator,
NRS Permissions CC
([email protected])
Agenda
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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
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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
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≥ one site in UK
CDA – Confidentiality Disclosure Agreements
Feasibility in Scotland
Protocol/Questionnaire
received by
NRS Permissions CC
Scottish Topic-specific
Network Managers
Commercial R&D
Managers & Facilitators
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
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•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
Initial approach to NRS Permissions CC
‘Full document set’
received by NRS Permissions CC
Lead Health Board
Local Health Board
Generic Review
Local Review
Certificate of Compliance
Management Approval
Processes run in parallel
30 calendar days from ‘full document set’ to R&D permission
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
Applicant notifies Permissions CC of UK-wide multicentre project
Permissions CC sends applicant ‘Document Submission Checklist’
Confidentiality Agreements as required
Applicant sends IRAS R&D application to Permissions CC;
and IRAS SSI Forms to PIs (UK-wide)
Permissions CC uploads documents to SReDA; notifies participating Scottish
R&D office(s); requests outstanding documents; assigns lead reviewer
Permissions CC emails IRAS
R&D Form to other UK
nation(s)
Permissions CC emails
global documents to other
UK nation(s)
Generic Review
Local Review(s)
Scottish sites
Certificate
of Compliance (CofC)
Permissions CC emails CofC
to other UK nation(s)
For each Scottish Health Board:
Local management permission letter
Permissions CC will confirm when we have a full document set
SSI Form
R&D Application Submission
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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)
R&D permission time (working days)
Median
Mean
30
27
24
25
22
21
20
20
18
17
18
15
15
15
13
13
10
5
0
Jan-Jun 10
Jul-Dec 10
Jan-Jun 11
Jul-Dec 11
Time period
Jan-Jun 12
Jul-Dec 12
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 Metrics
Commercial studies: R&D permission times (Jan 10 – Dec 12)
Median
30
Mean
25
25
R&D permission time
(working days)
21
20
18
19
19
16
20
18
20
21
18
16
15
10
5
0
Jan-Jun 10
Jul-Dec10
Jan-Jun 11
Jul-Dec 11
Time period
Jan-Jun 12
Jul-Dec 12
Commercial Feedback
No. of replies = 84
Unacceptable
Poor
Availability of
NRS PCC personnel?
Competence of
NRS PCC personnel?
1
Helpfulness/attitude/
flexibility of NRS PCC?
Overall experience?
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Acceptable
Good
Excellent
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34
44
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36
41
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26
54
6
35
41
“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.”
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 Walker
National Coordinator
NHS Research Scotland Permissions Coordinating Centre
(NRS Permissions CC)
[email protected]
Tel: 01224 554051
NRS Permissions CC Office
[email protected]
Tel: 01224 552690
Website: www.nhsresearchscotland.org.uk/NRSPCC