Has your organisation got any Clinical Trials of Medicinal Products (CTIMPs) planned in 2021? Our Combined Ways of Working (CWoW) pilot is now accepting expressions of interest from new applicants looking to submit in 2021. We are particularly keen to hear from NHS sponsors.
The pilot sees the HRA working closely with colleagues in the Medicines and Healthcare products Regulatory Agency (MHRA) and across the devolved administrations. It brings together a single Clinical Trial of Medicinal Product (CTIMP) application for both Clinical Trial Authorisation and Research Ethics Committee opinion.
Benefits of the CWoW process will 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 for 2021
To express an interest email firstname.lastname@example.org before your research team begins completing IRAS (applications must be submitted via a different part of IRAS).