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