March 2022: Changes to Automatic Registration

On 25 March 2022, HRA UK posted an update regarding the changes to the process of automatic registration for clinical trials of investigational medicinal products (CTIMPs) and combined investigational medicinal product and a medical device (IMP/device) trials submitted through combined review. If a trial approved through combined review is or will be registered on ClinicalTrials.gov, sponsors can request not to be automatically registered with ISRCTN Registry. Until 31 March 2022, if the sponsors have registered or plan to register on ClinicalTrials.gov, they must notify HRA via email [email protected].  From 31 March 2022, sponsors can specify this in their IRAS application.

Both ClinicalTrials.gov and ISRCTN will feed in to Be Part of Research if UK locations are included, bringing the goal of having a full record of all UK clinical trials in one single place closer.

More information regarding the updated process can be found here.