What: this update clarifies the HRA policy regarding registration of Clinical Trials of Investigational Medicinal Products (CTIMPs) with the EU Clinical Trials Information System (CTIS)
Who: CTIMP sponsors and research teams
When: updates and revisions live from Monday 29 January 2024
What is changing?
The Research Ethics Committee (REC) standard approval conditions have been updated to clarify that CTIMPs which are only registered with the EU Clinical Trials Information System (CTIS) need to be registered on a public registry within six weeks of recruiting the first research participant in the UK. This ensures the trial meets the HRA's research transparency requirements and the conditions of REC approval.
In line with other CTIMPs taking place in the UK, research teams conducting a CTIMP here as well as in countries in the European Union (EU) or European Economic Area (EEA), need to register the trial with a registry such as ISRCTN and ClinicalTrials.gov.
The current HRA policy will now make it clear that 'public registry' means:
'any registry on the World Health Organisation (WHO) list of primary registries or the International Committee of Medical Journal Editors (ICMJE) list of registries which facilitates public access to information about the UK trial.'
Why is this important?
CTIS, the online system for the regulatory submission, authorisation and supervision of clinical trials in the EU and the EEA, does not allow users to submit information about UK CTIMPs conducted as part of a multinational trial.
This means that the UK component of such trials will not be visible. This does not support our research transparency vision for trusted information from health and social care research studies to be publicly available for the benefit of all.
Registration with CTIS also does not meet the requirement for a ‘public registry’ as it is currently not a WHO primary or ICMJE approved registry.
When will this happen?
Updates to the HRA website are live now and revised approval letters and conditions will be used from today, Monday 29 January 2024.
What do I have to do?
As explained above, if your trial is taking place in the EU and the UK, you need to register with both CTIS and a WHO primary registry or ICMJE approved registry that facilitates public access to information about the UK trial such as ISRCTN or ClinicalTrials.gov. This enables public access to information about the UK trial and makes sure you are complying with the conditions of REC approval.