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 email@example.com 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
- instructions for sponsors- post approval submissions including substantial amendments/end of trial notifications
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
- UK Study Wide Review template (for trials taking place in the NHS/HSC only).
|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|