What is it? Why is it important?
An audit is a systematic examination of study activities conducted by the SP-INV to verify study compliance.
The SP-INV can perform an audit at:
The SP-INV can initiate an audit at a study site based on:
- Suspicion of misconduct (e.g. non-compliance with the study protocol)
- Mismanagement issues and poor study oversight (e.g. poor handling of IMP/MD and Biological Material, staff training and responsibilities)
- Findings during site monitoring (e.g. loss of data, protocol compliance issues, poor ISF filing)
The decision to conduct an audit is weighed against study risk criteria, such as the ongoing:
High priority circumstances include:
- Detected irregularities during study monitoring (e.g. non-compliance issues with the study protocol)
- Higher risk studies (e.g. Swissmedic with risk-category B or C studies)
- Inclusion of study participants (e.g. large recruitment numbers, vulnerable population)
- Study type and complexity (e.g. multi-centre, blinded and randomised studies)
- The risk level of the study (e.g. first-in-man, placebo controlled studies)
What do I need to do?
When preparing for an audit, the SP-INV:
- Notifies the Site-INV of the upcoming audit
- Provides the Site-INV with the purpose and scope of the audit
- Selects independent auditors (i.e. independent from the study)
- Prepares, in collaboration with auditors, an audit agenda and an audit plan (i.e. how to conduct the audit and its focus)
- If applicable, requests site-specific documents for review, prior to the site audit
- Prepares the study team
- Reviews site documents to ensure they are complete, up to date, and correctly filed (e.g.study essential documents, ISF)
- Reviews local processes to ensure they are properly implemented (e.g. handling IMP/MD and Biological Material)
- Reviews study training and responsibilities (e.g. Site-Delegation-Log)
For more information refer to QM and Risks in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
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
ICH GCP E6(R2) – see in particular guidelines
- 4.1.4 Investigator general
- 4.9.7 Investigator records
- 5.1.2 Sponsor general
- 5.19 Audit
- 5.20 Noncompliance