Clinical Trials that are within the scope of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) as amended may be subjected to MHRA inspection. UK Inspectors have statutory rights; these include the rights to enter premises involved in CTIMPs to carry out inspections, take samples, request documentation and take copies of the documentation and seize substances, articles and documents. It is a criminal offence to obstruct an inspector during a statutory inspection.
The types of inspection that may be conducted that are applicable to non-commercial research are:
- Routine system inspection: these are scheduled inspections and the organisation would be notified in advance. Inspectors may select a number of trials to test the systems of an organisation or one study and that tests how procedures are applied in practice (this may involve selecting external sites or vendors involved in the trial)
- Triggered inspection as a result, if information received by the MHRA. In these circumstances, the organisation may receive little or no notification of the inspection