Audits are performed routinely by auditors, on behalf of Sponsor, to demonstrate that an organisation's clinical trial activities are conducted in compliance with UK clinical trials regulation, protocol, and SOPs. Auditing should be conducted on a frequency which is based on risk and proportionate to the complexity of the trial activities.
An audit schedule is prepared by the Quality Assurance Manager and indicates when planned audits shall occur. Additional audits may be performed if there is cause for concern or when requested by sponsor.
The auditor shall produce a report identifying any findings, which may be graded as Observations (opportunities for improvement) or Non-conformances (a non-conformance against UK clinical trials regulations, Protocol or SOP). Corrective and Preventive action (CAPA) will be agreed to 'fix' the problem and stop recurrence.
Inspections are performed by government regulators to ensure patient safety, welfare, scientific integrity and compliance with regulations for CTIMPs and Medical Device Clinical Investigations (MDCIs). The UK regulatory body is the Medicines and Healthcare products Regulatory Agency (MHRA), who approve any CTIMPs and MDCIs and must be informed of any substantial amendments, serious breaches, safety issues and trial end.
The MHRA perform regulatory inspections of trial sites or sponsors on a risk basis, although may also perform triggered inspection after a particular event. In most cases the MHRA shall inform the main contact (normally sponsor) of an inspection, but these may occasionally be unannounced.
