MHRA Statutory Good Clinical Practice Inspection

MHRA Statutory Good Clinical Practice Inspection - Imperial College

The College has received notice that the MHRA intend to inspect our GCP systems in July/August 2007.

The CRO is currently compiling a dossier of documentation that outlines our GCP compliance procedures and lists all our non-commercial clinical trials since 1st May 2005.  The dossier needs to be submitted to the MHRA by 24th May 2007. 

After review of the information we submit, the MHRA will provide times for the inspection and a visit schedule.  It is likely that the College will have 4-6 weeks between this time and the physical inspection.

As part of our document compilation we may be contacting Chief/Principal investigators and study teams to address gaps in the information provided to the CRO.  The provision of incomplete information to the MHRA will lead them to focus their interest on trials where there is incomplete information.

Should a member of the CRO contact you and request further information, please can you treat it as an urgent matter and provide the information promptly so that we can complete our submission in the defined timeframe.

If you are conducting a non-commercial clinical trial and do not have a sponsor approval letter from the CRO please contact us immediately for advice on how to proceed.

Further information will be provided by the CRO once the MHRA have outlined their requirements.