Clinical trial sponsors using the Integrated Research Application System (IRAS) launched by the UK Clinical Research Collaboration (UKCRC) in January 2008 can now process all of the data needed for an application involving an Investigational Medicinal Product (IMP) within the system.
IRAS is an online service that collates all of the information needed for research applications to seven regulatory bodies: the Administration of Radioactive Substances Advisory Committee, the Gene Therapy Advisory Committee, the Medicines and Healthcare products Regulatory Agency (MHRA), the Ministry of Justice (National Offender Management Service), National Health Service / Health and Social Care (HSC) R&D offices, NRES/ NHS / HSC Research Ethics Committees, and the Patient Information Advisory Group.
The system was developed in response to longstanding criticism from researchers that applying to conduct trials in the UK’s National Health Service involved filling in a bewildering variety of forms, many of them asking for the same details.
While the National Research Ethics Service, the division of the UK’s National Patient Safety Agency that developed the new system, has reported an “exceptionally positive” response to IRAS, until now the system has only collected information about IMPs that was required by other review bodies.
Although information could be imported and exported between IRAS and EudraCT, the European Union’s clinical trial database, further information had to be completed in EudraCT before an IMP application could be made to the MHRA, the UKCRC noted.
With the newly improved version of IRAS, all of the information about an IMP study can be entered in one place and researchers need only go to EudraCT to obtain their EudraCT number, the UKCRC said. It is now also possible to generate the MHRA application form in the appropriate formats directly from IRAS.
