Your Easy Guide to Clinical Studies

An audit is initiated by the SP-INV of a study, and is based on the following standardised activities.

 

Audit preparation, the SP-INV:

• Defines the audit scope, frequency, methodology (e.g. on-site or central), sites to be audited, including format and content of the audit report
• Notifies the participating study site (e.g. Site-INV) of the upcoming audit, and requests relevant study documents for review
• Forwards the audit agenda to the Site-INV

 

Audit conduct:

• Opening meeting. The audit team (e.g. defined by the SP-INV) informs about the aim and scope of the audit
• Auditors perform the audit (e.g. review processes and related documents, interview study staff on tasks and responsibilities)
• Closing meeting. Auditors summarise audit findings and address any remaining questions

 

Audit follow-up:

• Auditors prepare an audit report summarising findings and distributes it to the SP-INV and Site-INV
• Based on the audit report, the Site-INV provides auditors with a CAPA plan
• The CAPA plan is submitted to the SP-INV who approves the plan on how to correct and prevent findings. The plan includes a timeline needed for the resolution of finings with a reference to staff responsible for handling the findings

 

An audit can target specific aspects of a study, as well as its partners and service providers (e.g. laboratories, manufacturers, outsourced monitoring services, CROs).

• Any findings observed during an audit are documented in an audit report
• Findings are categorised according to level of risk to study participants and quality of study data (e.g. minor, major, and critical findings, according to EMA's grading of inspection findings)
• The auditee provides the SP-INV and auditors with a CAPA plan, where corrective and preventative actions are defined
• CAPA resolutions are given specific timelines, with high-risk findings requiring immediate action on the part of the study site
• Upon the successful completion of an audit, auditors can issue an audit certificate that is forwarded to the Site-INV to be filed in the ISF

 

The auditee or Site-INV responsible for a specific study site, must implement any corrective measures as defined in the CAPA plan. Thus, applicable control measures should be in place to ensure CAPA compliance, and the prevetion of future issues.

• Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

• Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

• Bern, Department of Clinical Research (DCR), dcr.unibe.ch

• Geneva, Clinical Research Center (CRC), crc.hug.ch

• Lausanne, Clinical Research Center (CRC), chuv.ch

• St. Gallen, Clinical Trials Unit (CTU), h-och.ch

• Zürich, Clinical Trials Center (CTC), usz.ch