The Health Research Authority (HRA) in conjunction with the Four Nations Contracting Leads Group have recently published the following updates to the commercial and non-commercial model agreements.
The UK Government has published its full response to the Lord O’Shaughnessy (LOS) Review, in commercial clinical trials in the UK. The Department of Health and Social Care (DHSC) led a press release on the response.
By Margaret Grayson and Jonathan Jackson, Co-Chairs of the PPI and Priority Setting Sub-Group, Northern Ireland Clinical Research Resilience and Growth Oversight Group (NI CRRG).
Queen’s University Belfast is to lead the Northern Ireland component of a new hub for behavioural research, directly supported by £10M investment, as part of a total £17M boost for behavioural science by the UK government.
The EU Medical Device Regulation (Regulation 2017/745) (EU MDR) and In Vitro Diagnostics Regulation (Regulation 2017/746) (EU IVDR) require the sponsors of clinical investigations and certain performance studies to be established in the EU (or Northern Ireland) or have a legal representative established in the EU (or Northern Ireland).
