ACCORD Update/Training Event The Changing Research Landscape 26th February 2019 Heather Charles Head of Research Governance

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

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. 

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…

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

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

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

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

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

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

Implementing a UK Local Information Pack (LIP) SUMMER 2019 Introduction of LIP in IRAS (downloaded) Replace emailing 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

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 – www.accord.scot Single Authorisation

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 www.accord.scot

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