Transcript Slide 1

NHS Research Scotland – an overview
Alison Walker
National Coordinator,
NRS Permissions CC
Commercial presentation, July 2011
NHS Research Scotland
Background
•
Collaboration between the Chief Scientist Office (CSO) and 14 unified NHS
Boards in Scotland
•
Equivalent functions to NIHR, NHS Trusts and DH R&D
•
Aim to agree and implement national policy to deliver greater efficiency
and effectiveness to the NHS R&D function and the Research Ethics
function
•
Pharma – more efficient service + one point of contact
•
Pan-Scotland working delivered through NRS regional arrangements
under which the less research active NHS Boards are linked to the 4 main
Boards eg. Commercial Managers meetings
•
Funding: CSO and Scottish Enterprise
NRS Health Boards
Regional nodes and hubs
NRS
Permissions
CC
Regional working – 4 hubs
- Ethics
- R&D permissions
NRS NE
NRS E
NRS Functions
Grampian - NRS Permissions CC
Glasgow - NRS IT lead (SReDA)
Lothian - NRS Contractual issues
and National training
Tayside - NRS Governance Issues
NRS W
NRS W
NRS SE
NRS Permissions CC
• Coordinating Centre, based in Aberdeen
• Dedicated administrative team
• Single point of contact for industry and investigators
• Manages streamlined process to obtain R&D permissions for
multicentre research in the NHS Scotland
• Liaises with NHS Board R&D offices to facilitate Board and
Management permission
• Contact point for rest of UK, even if 1 Scottish site
• Link with other UK coordinated systems eg. NIHR CSP Unit for
UK-wide projects
NRS Permissions CC – the team
• R&D Director (part-time)
Prof Alison MacLeod
• National Coordinator
Dr Alison Walker
• 2 Senior Administrators
Pamela Shand, Stewart Morgan
• 1 Administrator
Abi Ayorinde
R&D Permissions Process Overview
‘Full Document Set’
0d
NRS Permissions CC
Each Health Board
Generic Review
Local Review
Certificate of Compliance
Local Management
Permission
Time
Lead Health Board
30d
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?
Processes
•
Feasibility in Scotland
•
Scotland only study (multicentre)
•
UK-wide study (lead R&D office in Scotland)
•
UK-wide study (lead R&D office in other UK nation)
– submit to Scotland ‘in parallel’
– agreed ‘coordinated’ UK process
•
UK-wide study (not via eg. CSP process)
[even if only 1 Scottish site]
•
Amendments
•
Addition of new sites
Feasibility in Scotland
• No formal ‘adoption’ process in Scotland
• Feasibility service coordinated by Permissions CC
• 2 week turn-around for Scotland-wide Investigator response
• Permissions CC provides study information to:• R&D commercial managers (within agreed Health Boards)
• Scottish Clinical Specialty Lead (if applicable)
• Scottish Topic-Specific Research Network Managers
• Potential investigators approached/supported to participate
• Permissions CC actively chases responses and feeds back to
Industry
• Alternatively, at least involve the R&D commercial manager
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
Process: Scotland only study (multicentre)
Notification
Application
Check
Review
R&D Permission
Full
document
set
Applicant
notifies
Permissions
CC
Permissions
CC sends
Document
Submission
Checklist
Applicant
sends IRAS
R&D
application to
Permissions
CC
And IRAS SSI
Forms to PIs
Confidentiality
Agreements as
required
Generic
Review
Permissions CC
checks / uploads
document set
onto SReDA;
notifies
participating R&D
offices; requests
outstanding
documents
Certificate of
Compliance
(CofC)
Local Review(s)
Local
Management
permission
letter
SSI
Forms
Permissions CC will confirm when we have
a full document set
R&D application to Permissions CC / SSI Forms to PIs
• Email documents to generic address ([email protected])
• Minimum for Permissions CC to assign generic reviewer:• confirmation of Health Boards/sites
• protocol + Costing Template
• Can submit prior to receiving Ethics/MHRA approval
• Employ UK Costing Template (as basis for negotiation)
• Scottish model contract, draft:
mCTA, mCIA, mCTA-CRO, mCIA-CRO
• Company/CI send Site-Specific Information (SSI) Forms to
Scottish Principal Investigators (PIs)
Trial Budget Costing
• Company asked to submit UKCRN Budget for trial to NRS
Permissions CC
• Uploaded to web-based research database, as part of global
document set
• Generic Reviewer reads it alongside protocol and determines
whether ‘per patient fee’ is reasonable for Scotland, and if any
activity items missed from budget proposal
• Local costs then applied by commercial managers
Contract Negotiation
• Company asked to submit draft contract intended for use for trial
[ideally a model contract eg. mCTA] to NRS Permissions CC
• Uploaded to web-based research database, as part of global
document set
• Generic Reviewer reviews/negotiates the final template to be used
for Scotland, on behalf of all participating Scottish Health Boards
• Any specific locally-required changes may be applied by
commercial managers, prior to sign off with Health Board
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’
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
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
CSP Unit forwards IRAS R&D Form promptly to Permissions CC, along with global documents available
at that time
Lead CLRN collates global
documents and carries out global
governance checks
If ‘No’
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)
If ‘Yes’
Permissions CC waits for global
documents and Governance Report from
Lead CLRN
Follow process as if lead R&D office is in Scotland
Mini-generic
Review for
Scotland
[no documents/CofC need be forwarded
Local Review(s)
Scottish sites
to other UK nation(s)]
Certificate of
Compliance
For each Scottish Health Board: Local management permission letter
UK-wide study (not via eg. CSP process)
[even if only 1 Scottish site]
We encourage companies to submit R&D application to NRS
Permissions CC also for following scenario:-
• Only 1 site in Scotland, UK-wide study, but not applying for R&D
permission for English sites through the CSP process…
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
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?
To date, NRS R&D permission times measured from when
Permissions CC confirmed receipt of NRS full document set, to issue
of local Management permission at each participating Health Board
R&D office [as ‘Net NHS time’].
Commercial: R&D permission times
(May 09 – Dec 10)
Median
R&D permission time
(working days)
60
Mean
50
40
30
21
21
20
18
19
19
15
16
19
10
0
May-Dec 09
Jan-Jun 10
Jul-Sep10
Time period
Oct-Dec10
Feedback - commercial
No. of questionnaires received = 31
Unacceptable
Poor
Availability (NRS PCC personnel)?
Acceptable
Good
Excellent
3
13
14
4
10
15
Helpfulness/attitude/flexibility (NRS PCC
personnel)?
1
8
20
Helpfulness/attitude/flexibility (R&D office
staff)?
3
4
12
4
9
16
Competence (NRS PCC personnel)?
Overall experience of Scottish R&D
permission process?
1
1
What are we doing well?
•
Excellent communication from PCC contact - very clear on how process
worked and what was required.
• Approval granted extremely quickly, checks carried out in parallel with ethics.
• Permissions CC team attention to detail, constant contact, I was fully advised
of where we were throughout the process, friendliness, detailed checklist was
provided.
• Having 1 contact as opposed to 3.
• Communication of status, current outstanding documents.
• Communications with R&D personnel.
• Whole process was very smooth. No requirement to chase up
documentation. The whole set up process was short, painless and
streamlined!
What would you like to see improved?
•
Improve link between PCC and CSPU. Would like more coordination
between the two but not if it will slow things down.
• Relationship/system compatibility between devolved nations.
• Increased communication between Permissions CC & CSP and vice versa. 1
instance where docs transferred from NRS to CSP but weren't uploaded into
CSP system - caused delays to some English R&D approvals.
• R&D process was fine and within the expected timelines. Unfortunately
approval was delayed as the ARSAC application had not been submitted in
good time and the R&D approval was only signed once the ARSAC Certificate
was with R&D.
• I would like to see the UKCRN and NRSPCC more integrated. It was a
shame we had our chief investigator in England yet had to resubmit the
documents rather than the CSP system being used.
What is NRS doing now?
Now a firmer focus on “outward function”:• Maintaining register of Scottish clinicians
• Website updates
• Business development: approaching companies to present ‘on
site’ about NRS, Scottish and UK R&D permissions processes,
and NRS performance metrics/feedback
• Via NHS/Industry partnership forum, linking with Pharma
companies and with ABPI (regular meetings of Pharma
representatives, CSO (Government) and the 4 R&D Directors)
• Specifically working with commercial Clinical Operations Group
(cCOG)
ABPI / CSO / NRS Partnership Workshops
• Workshop held July 2010 Edinburgh, involving
operational staff from industry and NHS R&D office
colleagues, ABPI and CSO
• Further workshop January 2011 London, areas of
focus:
- Engagement
- Trial Start-up
- Optimal recruitment
Workshop Action Groups
• 3 action groups set up with members from
Industry / CSO / ABPI / R&D staff
• Brief is to improve each of the 3 areas:-
- Engagement of industry with R&D offices,
Permissions CC, Investigators
- Trial set up (from R&D permission to recruitment of
first patient)
- Recruitment
What have we done so far ?
Progress of Workshop Action Groups
•
Engagement
Regional Commercial Trial Facilitators nearly all in place to support trials
requiring access to patients in both primary and secondary care.
Agreed that R&D offices should be notified of SIVs by companies and attend these
where appropriate.
• Best Practice
A list of patient databases in Scotland is being collected by the Informatics Centre in
Dundee for potential use by industry for site selection and feasibility.
• Recruitment
Key management information data for studies approved from April 2010 being
collected by all Boards. The RAG (Red, Amber Green) mechanism is being introduced
by the NRS Commercial managers to proactively manage and monitor recruitment.
Agreed that Industry should share recruitment data they have collected with R&D
offices on a regular basis.
New Support for Clinical Trials
•
Commercial Facilitators
- 2 in each node for primary and secondary care.
- Dedicated to assist with feasibility, start up and
recruitment.
- Work under direction of Commercial Managers.
• Pool of nurses
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: http://www.NRSPCC.org