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NHS Research Scotland - Overview- Feasibility- R&D permissions
Dr Alison Walker
National Coordinator,
NRS Permissions CC
Commercial presentation
NHS Research Scotland (NRS)
• Collaboration– CSO– 14 NHS Boards in Scotland
• Funding– CSO and Scottish Enterprise
• Function– coordinate R&D processes and systems
CSO – Chief Scientist office
‘..agree and implement national policy to deliver greater efficiency in the NHS R&D and Research Ethics function’
More efficient and effective service for Pharma
NRS – ‘hub & spokes’
NRS PCC – NRS Permissions Coordinating CentreNHS GG&G – NHS Greater Glasgow & Clyde
Regional arrangements deliver coordinated systems to facilitate clinical research
NRS WNRS SE
NRS E
NRS N
NRS SW
NRS PCC• Four regional hubs
–NRS N (NHS Grampian)• NRS Permissions CC
–NRS SW (NHS GG&C)• IT systems lead (SReDA)
–NRS SE (NHS Lothian)• Contracts• National training
–NRS E (NHS Tayside)• Governance
NRS Permissions CC
• Dedicated administrative team• Coordination
– Feasibility– Master CDAs– R&D permissions process for multicentre1 studies
• Single point of contact• Contact point for rest of UK – link with other
coordinated systems:- eg. CSP Unit, NISCHR PCU
Streamlined process to obtain R&D permission for multicentre research in Scotland
CDAs – Confidential Disclosure Agreements
1 Multicentre = > 1 Health Board/Trust in UK
NRS Permissions CC – the team
• Director– Professor David Reid
• National Co-ordinator– Dr Alison Walker
• Senior Administrators– Pamela Shand– Karen Innes
• Administrator– Lindsay Grant
Processes managed by NRS Permissions CC
• Feasibility in Scotland
• Coordination of R&D permissions process
• Amendments
• Addition of new sites
Feasibility in Scotland
• No formal ‘adoption’ process in Scotland
• Feasibility request/questionnaire/CDA sent to Permissions CC
• Permissions CC forwards study information to:-• R&D commercial managers/facilitators (agreed Health Boards)• Scottish Clinical Specialty Lead (if applicable)• Scottish Topic-Specific Research Network Managers
• Investigators approached/supported to participate• 2 week deadline for response
• Permissions CC actively chases / feeds back to Industry
• Companies are put directly in touch with interested parties to take discussions forward
• At least involve NHS R&D commercial managers
Scotland: therapeutic areas of expertise
• Cardiovascular Disease Dermatology
• Gastrointestinal Disease Infectious Disease
• Inflammation/Immunology Metabolic Disease/Diabetes
• Neuroscience Oncology
• Opthalmology Mental Health
• Respiratory Disease Stroke
• Tissue Research 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 eg. Diabetes, Mental Health, Dementia, Cancer, Stroke, Medicines for Children, Primary Care
When to use NRS Permissions CC
• More than one Board/Trust within UK– Regardless of adoption in England– Regardless of use of CSP, etc.
• Only time NRS Permissions CC is not used is for SINGLE SITE IN UK studies
‘Full Document Set’
NRS Permissions CC
Generic Review Local Review
Certificate of Compliance Local Management Permission
Lead Health Board Each Health Board
Tim
e
0d
30d
R&D Permissions Process Overview
NRS R&D Permission Process(es)
R&D permissions process in Scotland is
simple, but can vary depending on:-
• single- or multicentre?
• UK-wide study?
• lead R&D office?
UK-wide study (lead R&D office in Scotland)
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
Permissions CC will confirm when we have a full document set
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 to Permissions CC / SSI Forms to PIs
• Email documents to [email protected]
• Minimum for Permissions CC to assign generic reviewer:-
• confirmation of Health Boards/sites
• protocol + Costing Template + draft contract
• Can submit prior to receiving Ethics/MHRA approval
• Employ UK CRN Industry Costing Template
• Scottish model contract, draft:
mCTA, mCIA, mCTA-CRO, mCIA-CRO
Budget and Contract
• Budget–UK CRN Industry costing template
• PbR MFF Scotland = 1.2; (negotiable for smaller Boards)
–Generic review• Accuracy; Per patient fee; Additional costs
–Local review• Board specific requirements
• Contracts–ABPI mCTA – SCOTLAND 2011–Generic review
• Final template for Scotland
–Local• Board specific requirements
UK CRN – UK Clinical Research NetworkPbR MFF – Payment by Results Market Forces FactormCTA – model Clinical Trial Agreement
Scotland wide set up fees
Type of fee Cost (inc. PbR MFF)
R&D set up fee £840 (As per costing template)
Pharmacy set up fee Dependent on study type as per costing template
Site set up fee £500 Observational
£1000 Phase 3/4
£1500 Phase 1/2 or GM
ARSAC inc Local Med Phys Expert
£500
Archiving fee (per box) £300
PbR MFF = Payment by Results Market Forces FactorGM = Genetically Modified
UK-wide study (lead R&D office in other UK nation)
Applicant submits R&D application to other UK nation eg. to NIHR CSP Unit via IRAS
Lead CLRN collates global documents and carries out global
governance checks
CSP Unit forwards IRAS R&D Form promptly to Permissions CC, along with global documents available at that time
Permissions CC contacts study contact promptly to recommend submitting to Scotland (via Permissions CC) in parallel, as well as remind about Scottish SSI Forms for
local Scottish PI(s)
Follow process as if lead R&D office is in Scotland
[no documents/CofC need be forwarded
to other UK nation(s)]
Permissions CC waits for global documents and Governance Report from
Lead CLRN
Mini-generic Review for Scotland
Certificate of Compliance
Local Review(s) Scottish sites
For each Scottish Health Board: Local management permission letter
If ‘No’If ‘Yes’
How you can help speed up the process ?
• Apply for R&D permission prior to receiving REC/MHRA approval• Documents you send to a REC, send also to Permissions CC (incl. interim)
• Use the NRS Document Submission Checklist
• Send correct versions of necessary documents to NRS Permissions CC electronically
• Employ Scottish model contracts “as published”
• Obtain PIs’ support prior to sending out Site-Specific Information (SSI) Forms and let them know that the SSI Form is on it’s way
• Submit amendments sent to a REC to NRS Permissions CC also, and at the same time
Commercial customers should also:-
• Employ the UK CRN Costing Template
• Get in touch with NRS Permissions CC early to discuss CDAs
• Get in touch early on to initiate contract / budget discussions with the Commercial Manager of the lead R&D office
Processes for: Amendments, New Sites
Amendments
• Permissions CC coordinates amendments for NRS projects
• Permissions CC should receive documentation, to upload and notify participating Health Boards / other UK nation
New sites
• Adding new Scottish site to Scottish multicentre study, post R&D permission
• Adding new Scottish site to single-Scottish-site study, post R&D permission
• Adding 1st Scottish site to UK study
Benefits of usingNRS
PermissionsCC
Escalation
Project Alert Reports
Work Area Alerts
NRS teleconferences
One source of requests for global documents
Submit information only once to
Scotland
Centralised project
coordination and management
One source of study-wide project queries
Project tracking:
adherence to target
timelines
Efficient addition of new sites
Coordination of amendments
Single point of entry for
multicentre permission applications
Improved efficiency –
reduced duplication
We can put you in touch with the right people
No adoption process
NRS R&D permissions performance oversight
Active project management
• Circulation of ‘Project Alert Report’ every 2 weeks
• NRS teleconference every 2 weeks, to discuss projects with key
R&D office staff from each Node - chaired by Permissions CC,
representation from CSO
• Permissions CC team chases updates / actions / resolution
• Escalation procedure
• SReDA ‘Work Area’ alerts – at 20 and 30 calendar days
How is Scotland performing?
NRS R&D permission times measured from:-
receipt of NRS full document set, to issue of local Management
permission at each participating Health Board R&D office
[as ‘Net NHS time’].
NRS Performance Metrics – commercial
Commercial studies: R&D permission times (Jan 10-Jun 12)
1816 16
18 1816
19 1921 20
22
18
0
10
20
30
Jan-Jun 10 Jul-Dec10 Jan-Jun 11 Jul-Dec 11 Jan-Mar 12 Apr-Jun 12
Time period
R&
D p
erm
iss
ion
tim
e (
wo
rkin
g d
ay
s)
Median
Mean
Commercial project stats
Commercial clients to date - 112 Pharmaceutical / Device companies 44 Clinical Research Organisations
No. of projects received to date: 347
65% of studies use only 1 Scottish site
Feasibilities conducted via NRS Permissions CC: 138• 41 through NRS-PPD alliance• 12 through NRS-Quintiles Prime Site alliance• 85 direct from Pharma
No. of feedback questionnaires received = 66
Unacceptable Poor Acceptable Good Excellent
Availability (NRS PCC personnel)? 3
26 35
Competence (NRS PCC personnel)? 1 4 29 30
Helpfulness/attitude/flexibility? 1
21 41
Overall experience of the process? 1 6 28 30
Ongoing/Future plans
• Website update– Link with Health Sciences
Scotland
• Improve feasibility– Commercial Facilitators
• R&D involvement in Site Initiation Visit
• Pharmacy Working Group
• Patient databases• Capability statements
• Communication Plan• Collection of agreed
metrics• Actively manage
recruitment• Pharma/CRO and R&D
Collaboration – Recruitment/troubleshooting
• Agreed Scotland wide set up fees
Supporting clinical studies
• Commercial Facilitators– 2 in each node (primary and secondary care)– Assist with feasibility, start up and recruitment
• Nurses– Dedicated research nurses– Help with resourcing nurses– Expert support for investigators
• Imaging infrastructure– Dedicated scanners and reporting
NRS Permissions CC Contact details
Dr Alison WalkerNational 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: http://www.NRSPCC.org
Health Science Scotland is uniquely placed to set up
collaborations between companies and researchers.
Graeme Boyle: Senior Program Manager
www.healthsciencescotland.com- Researchers- Research areas and assets- Our population- Case studies
Health Science Scotland
