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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.

The pilot is currently open to applications by prior agreement only, with the expectation that it will be opened up to all CTIMP applications as it develops. If you are interested in submitting an application into this pilot, please email cwow@hra.nhs.uk and include ‘combined ways of working pilot’ in the subject line.

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 have been working with EU Member States to develop harmonised templates for documents which will form of the Part 2 application dossier. These templates have now 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. Whilst these harmonised templates have been agreed at an EU level, national guidance should always be consulted prior to using these templates as there may be some variation in what is required.  

 These templates can also be used prior to the Regulation applying, subject to national arrangements. In the UK, we encourage use of these templates when submitting applications into the Combined Ways of Working pilot (currently not for non CWoW application), in accordance with the application dossier guidance.  

  • The following  templates are currently available 

     - Investigator CV template

     - Declaration of Interest template

     - Recruitment and informed consent procedure template

     - Payment of compensation template

     - CWoW ethical considerations form

     - non NHS/HSC Site Assessment Form

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

Key dates

REC name Submission open Submission closed Meeting date
Bristol Central 3 Apr 2020 10 Apr 2020 24 Apr 2020
Bristol Central 8 May 2020 15 May 2020 29 May 2020
Bristol Central 10 Jul 2020 17 Jul 2020 31 Jul 2020
London Westminster 7 Apr 2020 14 Apr 2020 28 Apr 2020
London Westminster 9 Jun 2020 16 Jun 2020 30 June 2020
London Westminster 7 Jul 2020 14 Jul 2020 28 Jul 2020
London Hampstead 22 Apr 2020 29 Apr 2020 13 May 2020
London Hampstead 20 May 2020 27 May 2020 10 Jun 2020
London Hamptead 17 Jun 2020 24 Jun 2020 8 July 2020
Oxford A 10 Apr 2020 17 Apr 2020 1 May 2020
Oxford A 15 May 2020 22 May 2020 5 Jun 2020
Oxford A 12 Jun 2020 19 Jun 2020 3 Jul 2020
Manchester Central 20 Apr 2020 27 Apr 2020 11 May 2020
Manchester Central 18 May 2020 25 May 2020 8 Jun 2020
North West- Haydock 21 Apri 28 Apr 2020 12 May 2020
North West- Haydock 19 May 2020 26 May 2020 9 Jun 2020
North West- Haydock 23 Jun 2020 30 Jun 2020 14 Jul 2020
Leeds East 13 Apr 2020 20 Apr 2020 4 May 2020
Leeds East 11 May 2020 18 May 2020 1 Jun 2020
Health and Social Care REC A 7 Apr 2020 14 Apr 2020 28 Apr 2020
Health and Social Care REC A 5 May 2020 12 May 2020 26 May 2020
Health and Social Care REC A 9 Jun 2020 16 Jun 2020 30 Jun 2020
Health and Social Care REC B 16 Apr 2020 23 Apr 2020 7 May 2020
Health and Social Care REC B 14 May 2020 21 May 2020 4 Jun 2020
Health and Social Care REC B 11 Jun 2020 18 Jun 2020 2 Jul 2020
North East- York 10 Apr 2020 17 Apr 2020 1 May 2020
North East- York 15 May 2020 22 May 2020 5 Jun 2020
North East- York 12 Jun 2020 19 Jun 2020 3 Jul 2020
Berkshire B 19 May 2020 26 May 2020 9 Jun 2020
Berkshire B 23 Jun 2020 30 Jun 2020 14 Jul 2020
London Surrey Borders 23 Mar 2020 1 Apr 2020 15 Apr 2020
London Surrey Borders 1 May 2020 6 May 2020 20 May 2020
London Surrey Borders 27 May 2020 3 Jun 2020 17 Jun 2020
London Surrey Borders 24 May 2020 1 Jul 2020 15 Jul 2020
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