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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.admin@nhs.net 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

     - Declaration of Interest

     - Recruitment and informed consent procedure

These documents are also available on the EudraLex website.


Key dates

REC name Submission open Submission closed Meeting date
Bristol Central 7 Feb 2020 14 Feb 2020 28 Feb 2020
Bristol Central 6 Mar 2020 13 Mar 2020 27 Mar 2020
London Westminster 4 Feb 2020 11 Feb 2020 25 Feb 2020
London Westminster 10 Mar 2020 17 Mar 2020 31 Mar 2020
London Westminster 7 Apr 2020 14 Apr 2020 28 Apr 2020
West of Scotland REC 1 11 Feb 2020 18 Feb 2020 3 Mar 2020
West of Scotland REC 1 17 Mar 2020 24 Mar 2020 7 Apr 2020
East of Scotland REC 2 11 Feb 2020 18 Feb 2020 03 Mar 2020
East of Scotland REC 2 17 Mar 2020 24 Mar 2020 07 Apr 2020
London Hampstead 18 Mar 2020 25 Mar 2020 8 Apr 2020
Oxford A 14 Feb 2020 21 Feb 2020 06 Mar 2020
Manchester Central 17 Feb 2020 24 Feb 2020 09 Mar 2020
Manchester Central 23 Mar 2020 30 Mar 2020 13 Apr 2020
North West- Haydock 18 Feb 2020 25 Feb 2020 10 Mar 2020
North West- Haydock 24 Mar 2020 31 Mar 2020 14 Apr 2020
Leeds East 10 Feb 2020 17-Feb 2020 02 Mar 2020
Leeds East 17 Mar 2020 24 Mar 2020 07 Apr 2020
Health and Social Care REC A 4 Feb 2020 11 Feb 2020 25 Feb 2020
Health and Social Care REC A 4 Mar 2020 11 Mar 2020 24 Mar 2020
Health and Social Care REC B 20 Feb 2020 27 Feb 2020 12 Mar 2020
North East- York 13 Mar 2020 20 Mar 2020 3 Apr 2020
Berkshire B 24 Dec 2020 31 Dec 2020 14 Jan 2020
London Surrey Borders 25 Dec 2019 01 Jan 2020 15 Jan 2020
London Surrey Borders 29 Jan 2020 05 Feb 2020 19 Feb 2020
London Surrey Borders 26 Feb 2020 04 Mar 2020 18 Mar 2020
London Surrey Borders 25 Mar 2020 01 Apr 2020 15 Apr 2020
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