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Has your organisation got any Clinical Trials of Medicinal Products (CTIMPs) planned? Our Combined Ways of Working (CWoW) process is looking for more NHS-sponsored applications.

The HRA and Medicines and Healthcare products Regulatory Agency (MHRA) CWoW process tests a more integrated process for researchers and sponsors.. The pilot brings together a single Clinical Trials of Medicinal Products (CTIMPs) application for both Clinical Trial Authorisation and Research Ethics Committee opinion.

We are now accepting expressions of interest from new applicants looking to submit in 2021.

We are particularly keen to hear from NHS sponsors. To express an interest email cwow@hra.nhs.uk before your research team begin completing IRAS (applications must be submitted via a different part of IRAS).

Benefits of the CWoW process include

  • a single CTIMP application for both Clinical Trial Authorisation and REC opinion
  • smooth, streamlined and efficient application process
  • REC opinion and MHRA approval delivered together
  • any subsequent amendment is also jointly submitted
  • improved functionality in a new part of IRAS through out 2021

If you know you are looking to sponsor an application, please contact cwow@hra.nhs.uk, before the research team start completing IRAS.

Information for current CWoW participants can be found here.

Back to clinical trials of investigational medicinal products (ctimps)