What is it? Why is it important?
An audit is a systematic evaluation of study related activities including the review of essential documents, with the aim to determine study compliance with study protocol, SOPs, GCP and applicable regulatory requirements.
Audits are generally conducted to assess compliance with QA processes established by the SP-INV. Under special circumstances “for-cause” audits are implemented following the identification of critical issue(s).
SP-INV carries main study responsibility, which includes the implementation of a risk-based QMS.
As an integral part of QA activities, audits are conducted independently and separately from routine monitoring or other quality control functions. In contrast to an evaluation of study risks and monitoring activities, audits are not considered mandatory.
An audit is performed based on the following standardised procedures.
- SP-INV defines audit scope, frequency, how to audit, sites to be audited and form and content of the audit report
- SP-INV notifies the site of the upcoming audit, and requests applicable study documents for review
- SP-INV forwards the audit agenda to the Site-INV
- Opening meeting. The audit team informs about aim and scope of audit
- Auditors perform the audit (e.g. review processes and related documents, interview study staff on tasks and responsibilities)
- Closing meeting. Auditors address remaining open questions and summarise audit findings
- Auditors write an audit report summarising all findings and forwards to the SP-INV
- The Site-INV provides auditors with a CAPA plan, initially submitted and accepted by the SP-INV on how to correct and prevent findings. A timeline needed until resolution is included as well as any responsible staff handling the finding.
An audit can target a given study but also its partners and service providers (e.g. laboratories, manufacturers, monitors, CROs).
What do I need to do?
As part of the QA strategy:
- Establish an audit plan that defines, who-, what-, when- and how to audit
- Use a risk based approach when planning the audit and focus on those study aspects holding the highest risk
- Adapt the audit scope according to study complexity, number of participants
- Select auditors that are independent of the study or system to be audited
- Ensure auditors are qualified by training and experience
For more information refer to Documents in this Study Guide
- Any findings observed during an audit are documented in an audit report
- Findings are categorised according to level of risk to study participants and to the quality of study data (e.g. minor, major, and critical findings)
- The auditee must provide the SP-INV with a CAPA plan, where corrective and preventative actions are defined (e.g. Site-INV, laboratory performing analysis for the study, outsourced services such as monitoring, data management, statistics)
- CAPA resolutions are given specific timelines, with high risk findings requiring immediate action on the part of the study site
- Upon successful audit completion auditors can issue an audit certificate that is forwarded to the SP-INV to be filed in the TMF
In order to be sustainable, the auditee or the Site-INV responsible for a specific 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 compliance.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 1.6 Audit definition
- 5.18 Study monitoring
- 5.19 Audit
ISO 9001:2015 – see in particular section
- Quality Management Systems (access liable to costs)