FAQs |
How are clinical trial participants to be protected under the Regulations?
I have heard that there is no requirement for a single sponsor under the UK Regulations. What are the Regulatory requirements for sponsorship?
It was clear from consultation that this is a major concern in publicly funded trials. The EU Directive does require a sponsor to take responsibility for the initiation, management and/or financing of a trial. In commercial trials it is normal for the owner of the medicine under investigation to take responsibility for all the sponsor’s duties. In publicly funded trials the responsibilities are often distributed among the partners.
The UK Regulations allow a partnership or group between them to take this responsibility. Under this approach, the applicant for a CTA can either accept all of the sponsor’s responsibilities or to notify the MHRA that its partners accept responsibility for some functions. Regulation 3 specifies how they can do this.