The sponsor of a clinical trial is responsible for implementing quality systems including the development of an audit plan for the trials they manage. Audit is designed to assess and assure the reliability and integrity of sponsor’s trial systems against all relevant written standards.
Activities and system checks which may be undertaken during an audit include:
- Staff interview: To assess whether staff working on the trial are appropriately trained, are clear of their role and are working to all relevant standards, the protocol and standard operating procedures (SOPs)
- Facility Tour: To assess whether there are adequate resources and that any equipment is fit for its intended use
- Document Review: To assess whether data reported is verifiable from source data and that written records confirm that the trial was conducted appropriately.
Auditors should be independent of the trial team / process and should be appropriately trained for their role. Findings and observations from any audit conducted should be documented in a formal audit report. Any deficiencies identified during an audit should be followed up with appropriate corrective and preventative actions wherever possible.
Audits that are conducted by regulatory authorities (such as the MHRA) are termed inspections (see MHRA Inspection station for more detail).
- The NIHR Research Support Services Framework documents: RSS Framework-Annex4-P08-Oversee study (May 2011).