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, how to audit or type (e.g. on-site or central), sites to be audited and form and content of the audit report
• Notifies the participating study site (e.g. Site-INV) of the upcoming audit, and requests applicable 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 address any remaining open questions and summarise audit findings

 

Audit follow-up:

• Auditors write an audit report summarising findings and distributes them 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 a given study but also 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

 

In order to be sustainable, the auditee or the Site-INV responsible for a specific study site is responsible to implement any corrective measures as defined in the CAPA plan. Thus, applicable control measures should be in place in order to ensure CAPA compliance.

• Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch

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

• Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch

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

• Lausanne, Clinical Research Center, CRC, www.chuv.ch

• St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch

• Zürich, Clinical Trials Center, CTC, www.usz.ch