1. ACCORD Update/Training Event The Changing Research Landscape 26th February Heather Charles Head of Research Governance

2. Overview Four Nations NHS/HSC Compatibility Programme
Combined Ways of Working (CWoW)
Implementing a UK Local Information Pack (LIP)
Schedule of Events Cost Attribution Tool (SoECAT)
Other Changes

3. Four Nations NHS/HSC Compatibility Programme
The aim is to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland.
Researchers/Sponsors will benefit from these changes, particularly when setting up studies with sites in more than one UK country
Consistent nationwide approach to sharing information between Sponsor and sites 
Single ethics and R&D online submission from the Integrated Research Application System (IRAS)
Improved UK-wide approach to amendments. 

4. Four Nations NHS/HSC Compatibility Programme
UPDATED PROGRAMME SCHEDULE
Original Four Nations Plan
Revised Four Nations Plan
Projected Completion: July 2018
Projected Completion: March 2020
Scope: Local Information Pack, e-submission, Amendments.
Revised Scope: Local Information Pack, e-submission, Amendments, SReDA, HARP, Joined Up Validation, Brexit, New IRAS, Study-Wide Review, CWoW, Joined Up Outcome, Research Passports etc…

5. Four Nations NHS/HSC Compatibility Programme
UPDATED PROGRAMME SCHEDULE
Delivered to Date
Next Steps (Q1/2 2019)
JULY 2017: E-submission – Combined REC and R&D form
JANUARY 2019: E-submission phase 3 – REC alerts in HARP
MAY 2018: GDPR – Guidance and training for Generic Reviewers (R&D)
FEBRUARY 2019: SReDA – v3.0 (R&D database) released
JULY 2018: E-submission phase 1 – All studies routed via HARP and NRS PCC
APRIL 2019: CWoW – Pilot ends and goes ‘live’
JUNE 2019: Local Information Pack – Replacing SSI out with IRAS initially
UK study-wide criteria overhaul

6. Four Nations NHS/HSC Compatibility Programme
UPDATED PROGRAMME SCHEDULE
Delivered to Date
Next Steps (Q1/2 2019)
JULY 2017: E-submission – Combined REC and R&D form
JANUARY 2019: E-submission phase 3 – REC alerts in HARP
MAY 2018: GDPR – Guidance and training for Generic Reviewers (R&D)
FEBRUARY 2019: SReDA – v3.0 (R&D database) released
JULY 2018: E-submission phase 1 – All studies routed via HARP and NRS PCC
APRIL 2019: CWoW – Pilot ends and goes ‘live’
JUNE 2019: Local Information Pack – Replacing SSI out with IRAS initially
UK study-wide criteria overhaul

7. The Combined Ways of Working Pilot (CWOW)
Test of streamlined CTIMP review process in the UK
MHRA & HRA in partnership with the Devolved Administrations
Aligns with EU Clinical Trial Regulation 536/2014 (expected 2020)
Single submission (IRAS) – Coordinated review REC & CTA & SWR
Single validation
Application dossier
Single request for further information
Single authorisation
Reduce duplication, contradiction, confusion, timelines
Fewer amendments
Single Authorisation
Assess
REC
CTA
Single Authorisation

8. The Combined Ways of Working Pilot (CWOW)
Pilot since April 2018
11 RECs involved
Short term
Continuing in pilot phase (open to all)
Developing process
Developing internal infrastructures & support
Long term
Roll out co-ordinated process
Single Authorisation
Single Authorisation
Assess
REC
CTA
Single Authorisation

9. The Combined Ways of Working Pilot (CWOW)
“It’s great to have a more joined up approach from the regulators. The interaction and co-ordination between the REC and the MHRA works really well.”
“Overall we have seen a significant decrease in MHRA and REC approval timelines which has been welcomed by our clients; the pilot process was straightforward and fitted well into our established processes.”
Single Authorisation
Single Authorisation

10. Implementing a UK Local Information Pack (LIP)
Improving compatibility for cross-border research within the UK
Healthcare research sponsors and applicants will benefit from:
Compatible UK-wide processes leading to consistent and expected outcomes
Reduced cross-border confusion and differing types of application forms
Electronic submission and sharing of documents to hosting organisations.
Single Authorisation

11. Implementing a UK Local Information Pack (LIP)
SUMMER 2019
Introduction of LIP in IRAS (downloaded)
Replace ing local information pack in England, replacement of Statement of Activities for non-commercial studies, and use of SSI form use in Scotland, Wales, and Northern Ireland.
Hard stop on SSIs.
Single Authorisation

12. Schedule of Events Cost Attribution Tool (SoECAT)
OCTOBER 2018
Change in the way that NHS costs are reviewed during grant applications
Driven primarily by new ways of handling NHS Excess Treatment Costs (ETCs) in England
Affect Scottish organisations applying to UK funders
No changes are currently planned to the way in which ETCs are handled in Scotland.
The SOECAT sets out the activities on the study
Reviewed and signed off by the local NHS R&D office.
Training events in Scotland February/March 2019
More information –
Single Authorisation

13. Other Changes
Central Portfolio Management System (CPMS) – Recruitment Data
EU Clinical Trials Regulation – Adopted 2014 (Implementation 2020?)
Medical Devices Regulation – Transitional Period (Implementation May 2020/2022)
Brexit

14. QUESTIONS?