NHS Research Scotland – an overview

Alison WalkerNational Coordinator,NRS Permissions CC

Commercial presentation, July 2011

NHS Research Scotland

• 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

Background

NRS Health Boards

Regional nodes and hubs

NRS W

NRS PermissionsCC

NRS SE

NRS E

NRS NE

NRS WNRS FunctionsGrampian - NRS Permissions CC

Glasgow - NRS IT lead (SReDA)

Lothian - NRS Contractual issues

and National training

Tayside - NRS Governance Issues

Regional working – 4 hubs- Ethics- R&D permissions

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

‘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?

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

Applicant sends IRAS

R&D application to

Permissions CC

And IRAS SSI Forms to PIs

Applicant notifies

Permissions CC

Permissions CC sends Document

Submission Checklist

Permissions CC checks / uploads

document set onto SReDA;

notifies participating R&D offices; requests

outstanding documents

Notification Application Check Review R&D Permission

Generic Review

Local Review(s)

Local Management permission

letter

Full document

set

SSIForms

Permissions CC will confirm when we have a full document set

Certificate of Compliance

(CofC)

Confidentiality Agreements as

required

Process: Scotland only study (multicentre)

R&D application to Permissions CC / SSI Forms to PIs

• Email documents to generic address (nhsg.NRSPCC@nhs.net)

• 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’

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

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’

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)

2118

15 1621 19 19 19

0

10

20

30

40

50

60

May-Dec 09 Jan-Jun 10 Jul-Sep10 Oct-Dec10

Time period

R&

D p

erm

iss

ion

tim

e

(wo

rkin

g d

ay

s)

Median

Mean

Feedback - commercial

No. of questionnaires received = 31          

  Unacceptable Poor Acceptable Good Excellent

Availability (NRS PCC personnel)?     3

13 14

Competence (NRS PCC personnel)?   1  4 10 15

Helpfulness/attitude/flexibility (NRS PCC personnel)?

    1

8 20

Helpfulness/attitude/flexibility (R&D office staff)?

    3 4 12

Overall experience of Scottish R&D permission process?

    1 4 9 16

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 WalkerNational Coordinator

NHS Research Scotland Permissions Coordinating Centre(NRS Permissions CC)alisonwalker1@nhs.net

Tel: 01224 554051

NRS Permissions CC Office nhsg.NRSPCC@nhs.net

Tel: 01224 552690

Website: http://www.NRSPCC.org