There are a number of steps to follow before a trial can commence. The first step is to confirm whether it falls within the scope of the European Directive (2001/20/EC) (PDF, 152 KB). This Directive was transposed into UK law by means of The Medicines for Human Use (Clinical Trials) Regulations 2004, which together with its amendments, are referred to as the Clinical Trial Regulations within this Toolkit.
A Clinical Trials Regulations Flowchart (pdf, 76.83 KB) has been developed which describes the relationship between EU Directives and the Clinical Trial Regulations including a brief description of the regulation and each amendment. Any trial that falls within the scope of Directive 2001/20/EC is known as a Clinical Trial of an Investigational Medicinal Product (CTIMP).
The Medicines and Healthcare Regulatory Agency (MHRA) is the competent authority that regulates CTIMPs in the UK. The MHRA have produced an algorithm (PDF) to help researchers determine whether their trial is a CTIMP. Researchers planning a CTIMP should be familiar with the MHRA Clinical Trials Pages to help ensure all legal requirements are considered.