Content Comparison

The /wiki/spaces/WEL/pages/220168194 within the Data Transparency Working Group has published a new response to a question regarding MHRA Clinical Trials Regulation Guidance. View the team's response to the following question here.  

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK.

New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency (MHRA)’s updated clinical trials regulations which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. External stakeholders who wish to share feedback on the newly published guidance are asked to provide their submissions to the HRA.

View the team's response to the updated guidance here and associated MHRA algorithm document here.