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The HRA and Medicines and Healthcare products Regulatory Agency (MHRA) have been exploring opportunities to improve the service being offered for the approval and ongoing management of Clinical Trials of Medicinal Products (CTIMPs).

We see increased assimilation as a positive step forward. With that in mind we've launched a combined ways of working pilot to test an integrated process.

During the COVID-19 pandemic the pilot is continuing and we will continue to develop the system where possible, but the speed of the pace of further IT development on the Combined Ways of Working new module in IRAS will slow down. The pilot is not currently accepting applications from organisations which are not already involved in submitting applications under the pilot until further notice. If you would like to receive ongoing updates about how the pilot is developing and when the combined process will be available for new organisations, please e-mail cwow@hra.nhs.uk to be included on our communications e-mail list. 

The pilot process requires a single CTIMP application dossier to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion. In England and Wales this will also incorporate HRA and Health and Care Research Wales (HCRW) Approval.

The process involves a single submission, combined communications to request any further information required and a single communication to confirm the final decision.   

Only certain RECs are involved in this pilot, although the number involved continues to increase. 

The most up-to-date information about which RECs are taking part in the pilot and when they meet will always be included in the REC meeting schedule below.

Each REC meeting has a submission period within which applications must be submitted. Applications into the pilot must be received during the submission period for any chosen REC, otherwise the application will be allocated to the next available REC meeting. Please note the reservation of slots in advance is required to increase the chance of the meeting having availability.

Key guidance and documents

Templates

In preparation for the EU Clinical Trials Regulation we worked with EU Member States to develop harmonised templates for documents which will form of the Part 2 application dossier. These templates have been endorsed by the EU Clinical Trial Expert Group and published on the European Commission website. The purpose is to provide a suite of templates which clinical trial sponsors can access and use when submitting CTIMP applications to all EU Member States under the Regulation. The UK has left the EU (notwithstanding the transition period) but we are continuing to use the EU harmonised templates as part of the CWoW pilot, in accordance with the CWoW application dossier guidance.  

  • The following  templates are currently available 

     - Investigator CV template

     - Recruitment and informed consent procedure template

     - CWoW ethical considerations form

     - Payment of compensation template

    - UK Study Wide Review template
       (for trials taking place in the NHS/HSC only)

     - non NHS/HSC Site Assessment Form

     - Declaration of Interest template.




Key dates

REC name Submission open Submission closed Meeting date
Bristol Central 10 Jul 2020 17 Jul 2020 31 Jul 2020
Bristol Central 7 Aug 2020 14 Aug 2020 28 Aug 2020
Bristol Central 4 Sep 2020 11 Sep 2020 25 Sep 2020
London Westminster 4 Aug 2020 11 Aug 2020 25 Aug 2020
London Westminster 8 Sep 2020 15 Sep 2020 29 Sep 2020
London Hamptead 19 Aug 2020 26 Aug 2020 9 Sep 2020
East of Scot REC 2 14 Jul 2020 21 Jul 2020 4 Aug 2020
East of Scot REC2 11 Aug 2020 18 Aug 2020 1 Sep 2020
West of Scot REC1 11 Aug 2020 18 Aug 2020 1 Sep 2020
West of Scot REC 1 15 Sep 2020 22 Sep 2020 6 Oct 2020
Oxford A 17 Jul 2020 24 Jul 2020 7 Aug 2020
Oxford A 14 Aug 2020 21 Aug 2020 4 Sep 2020
Manchester Central 20 Jul 2020 27 Jul 2020 10 Aug 2020
Manchester Central 24 Aug 2020 31 Aug 2020 14 Sep 2020
North West- Haydock 18 Aug 2020 25 Aug 2020 08 Sep 2020
North West- Haydock 22 Sep 2020 29 Sep 2020 13 Oct 2020
Leeds East 13 Jul 2020 20 Jul 2020 3 Aug 2020
Leeds East 17 Aug 2020 24 Aug 2020 7 Sep 2020
Health and Social Care REC A 4 Aug 2020 11 Aug 2020 25 Aug 2020
Health and Social Care REC A 1 Sep 2020 8 Sep 2020 22 Sep 2020
Health and Social Care REC B 16 Jul 2020 23 Jul 2020 6 Aug 2020
North East York 17 Jul 2020 24 Jul 2020 7 Aug 2020
Berkshire B 21 Jul 2020 28 Jul 2020 11 Aug 2020
Berkshire B 18 Aug 2020 25 Aug 2020 8 Sep 2020
Cambridge and Herts 22 Jul 2020 29 Jul 2020 12 Aug 2020
Cambridge and Herts 19 Aug 2020 26 Aug 2020 9 Sep 2020
London Surrey Borders 26 Aug 2020 02 Sep 2020 16 Sep 2020
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