IRAS now includes full functionality for studies involving investigational medicinal products (IMPs)

9th March 2009

From 09 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). 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.