Notification

Cardiff University has received notification that it will be subject to a Medicines and Healthcare products Regulatory Agency (MHRA) statutory inspection anytime between now and September 2008 for its non-commercial Clinical Trials of an Investigational Medicinal Product (CTIMPs).  

The inspection will involve CTIMPs that are sponsored by Cardiff University or for which Cardiff University plays a key role. This may include employment of the Chief Investigator (CI), management of finances or contracts, or undertaking a delegated responsibility (e.g statistics).

An inspection date has not yet been received by the University but there is usually a 4- 6 week period between being given an inspection date and the inspection occurring. At this stage, the University should be given a draft inspection plan. One week prior to the inspection date, the MHRA will issue a trial inspection plan to the University. The inspection plan outlines activities that are to be covered by the inspection including names of CTIMPs to be inspected, a list of staff members which will be interviewed and the facilities they wish to inspect.  However, inspectors may deviate from this plan at any time. It is important to remember that the inspection is statutory and the MHRA will expect all individuals they wish to interview to make themselves available.

Pre- Inspection Dossier

The University has already provided a Pre- Inspection Dossier to the MHRA. The dossier included the following information:

-Complete list of non-commercial CTIMPs (from May 2005)

-Organisational charts

-Overview of all facilities

-Description of archiving arrangements

-SOP index

-Detailed procedures in relation to:

   •         Trial management

   •         Quality control and assurance

   •         Computerised systems

   •         Equipment maintenance

   •         Supply of Investigation Medicinal Product

   •         Laboratory procedures

-Activities carried out by CU or contracted out by CU