Inspection and audit are similar, both are intended to demonstrate compliance and identify opportunities for improvement.

Audits are performed routinely by competent auditors, on behalf of Sponsor, to demonstrate that an organisation's clinical trial activities are conducted in compliance with UK clinical trials regulation, protocol, sponsor SOPs and technical (study specific) 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.

Audits may be of the following type:

  • System audits - the functioning of complete systems (e.g. pharmacovigilance, monitoring, statistical analysis).
  • Facility audits - the operation of a particular department or team.
  • Third party audits - the service provided by a third party (e.g. CTU, IMP provider, laboratory providing end-point analysis).
  • Study specific - the activities involved in a particular study.
  • Documentation - study specific documentation, including software packages.

Auditors should be independent of the activities being audited and may not audit their own work. The auditor shall produce a report within a pre-set time period identifying any findings. These may be graded as Observations (opportunities for improvement, or areas where a potential non-conformance may occur if no improvements are made) or Non-conformances (a non-conformance against UK clinical trials regulations, Sponsor SOP or technical (study specific) SOP). Non-conformances should state the documentation against which non-conformance has been identified. Non-conformances may be graded as 'serious' or 'non-serious' as appropriate.

Corrective and Preventive action (CAPA) should be agreed with the auditor to 'fix' the problem and stop recurrence in the future. These should be addressed within a pre agreed timescale and when completed, to the satisfaction of the auditor, the finding may be closed.

Inspections are performed by government regulators to ensure patient safety, welfare, scientific integrity and compliance with regulations for CTIMPs. In the UK the regulatory body is the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA must approve any CTIMPs and 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 regular basis. The frequency of these inspections is based on the risk associated with the trials being undertaken. The MHRA 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.


Study Management

 

Consent and recruitment Progress and Safety Reporting Management and Monitoring Inspection and Audit End of Study Analyse Data Final Reports