Clarification of HRA policy on the registration of CTIMPS in the UK and EU

Clinical Trials of Investigational Medicinal Products (CTIMPs) taking place in the UK as well as in countries in the European Union or European Economic Area, must be registered with both the EU Clinical Trials Information System (CTIS) and a WHO primary registry or ICMJE approved registry, within six weeks of recruiting the first research participant in the UK. This is to ensure the trial meets the HRA's research transparency requirements and the conditions of Research Ethics Committee (REC) approval.

Examples of a WHO primary registry or ICMJE approved registry include ISRCTN or ClinicalTrials.gov. Read more about the update on HRA Now.