Our Combined Ways of Working (CWoW) pilot programme has reached another significant milestone, a total of 100 applications authorised.
The pilot sees the HRA working closely with colleagues in the Medicines and Healthcare products Regulatory Agency (MHRA) and across the Devolved Administrations to develop a single application route and a coordinated ethics and regulatory review leading to a single UK decision on a clinical trial.
The 100 approvals, reached this week, cover every phase of development, including first-in-human studies, with applications from both commercial and non-commercial sponsors. We now have 14 research ethics committees (RECs) involved in the pilot, covering the whole of the UK, as well as all MHRA Clinical Trials Unit assessors.
Next stepsThe milestone comes as the pilot moves into a new phase.
Over the past year MHRA and HRA have been working closely together to introduce some updated functionality to the Integrated Research Application System (IRAS) which will streamline the process even further. We’ve also been working together to ensure that our individual case management systems ‘speak’ to each other to assist with the review process.
Staff in MHRA, HRA and the Devolved Administrations, as well as trial applicants, have been testing the new system and on 2 March this year we launched a new automated technical solution for those applicants involved in the CWoW Pilot to use. This pilot is not currently accepting new sponsors. We will now be refining this process over the next few months. This means we can work towards opening the pilot to more applicants, generate more feedback and inform the next phase of systems development, preparing us for an exciting future!
Read more in this MHRA blog.
If you’d like more information on CWoW, please see the guidance on the HRA website. The pilot is not currently accepting new sponsors. 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.