FAQs

FAQ 1:

What is the purpose of the new Clinical Trials Directive?
FAQ 2:

What are the UK Regulations?
FAQ 3:

Are all clinical trials covered by the Regulations?
FAQ 4:

What steps are being taken to address the concerns of the publicly funded clinical trials community who fear that the transposition of this Directive could unnecessarily delay or stop trials
FAQ 5:

I have heard that there is no requirement for a single sponsor under the UK Regulations. What are the Regulatory requirements for sponsorship?
FAQ 6:

The Regulations extend to academically led clinical research. Will this impose burdensome responsibilities on doctors who undertake trials?
FAQ 7:

Do the Regulations apply to all products?
FAQ 8:

How are clinical trial participants to be protected under the Regulations?
FAQ 9:

Are medicines used in trials monitored under the Directive?
FAQ 10:

Are fees charged under the Regulations?
FAQ 11:

Is it not possible to differentiate between commercial and academic research for the purpose of charging fees?
FAQ 12:

What are the transitional arrangements for a trial that began before the Regulations were introduced?

FAQ 7:

Do the Regulations apply to all products?

Not all unlicensed chemical entities administered to patients or healthy volunteers are considered as investigational medicinal products. The Regulations apply only to those that are medicinal products and are to be tested or used as a reference in a clinical trial.

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