Is a clinical trial authorisation required?

Integrated Research Application System (IRAS) now includes full functionality for studies involving investigational medicinal products (IMPs)
From 9 March 2009 all the data that are required to make an application to the Medicines and Healthcare products Regulatory Agency (MHRA) for authorisation of a clinical trial of an Investigational Medicinal Product (IMP) can now be completed within the Integrated Research Application System (IRAS) (external link). Previously IRAS only collected information about the IMP that was also required by other review bodies. That meant that although information could be imported and exported between IRAS and EudraCT, further information also needed to be completed in EudraCT before an application to the MHRA could be made. Now through IRAS all the information about a study can be entered in one place and researchers need only to go to EudraCT to obtain their EudraCT number. IRAS contains extensive guidance to support researchers in completing their application form. Additionally, it is now possible to generate the application form to the MHRA in the appropriate formats directly from IRAS.


1. When is an authorisation (CTA) required?
The Regulations only apply to trials of medicinal products. These are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans.

A clinical trial is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.

Clinical studies involving only medical devices, food supplements or other non-medicinal therapies (such as surgical interventions) are not covered by the Directive.

The Regulations do not apply to non-interventional trials. In such trials, no additional diagnostic or monitoring procedure should be applied. Epidemiological methods should be used for the data analysis.

2. Is my study covered by the Directive?
To find out if your study is covered by the Directive or not, use the algorithm ‘Is it a clinical trial of a medicinal product?’ provided at the end of Volume 10 Notice to Applicants: Question & Answers - Clinical Trial Documents (external link) and reproduced below:

› Is it a clinical trial of a medicinal product?PDF file (opens in new window) (25Kb)

If, after using the algorithm, you are still unsure whether or not the clinical study is covered by the Directive then send an e-mail to the Clinical Trial helpline (clintrialhelpline@mhra.gsi.gov.uk) marked ‘Scope- protocol review’ in the subject line and request an opinion on the status of the study. A copy of the protocol should be provided with the request. Where possible, responses to such queries will be sent within seven days. Please note that queries of this type will not be answered by telephone.

3. Is the product an IMP or a NIMP?
The decision as to whether a product is an IMP or a NIMP depends on the product being used and the design of the study. Some mock examples have been produced in the setting of healthy volunteer studies to help in decision making. These are provided below:

› Mock examplesPDF file (opens in new window) (19Kb)


Page last modified: 30 July 2009