Conduct↦Quality and Risk↦Regulatory Inspections↦Conduct
What is it? Why is it important?
A regulatory inspection is a systematic and independent examination by a regulatory body (e.g. Swissmedic). Its purpose is to determine whether study is conducted according to the EC approved study protocol, ICH GCP, the SP-INV’s SOPs, the law (e.g. Swiss law), and other applicable regulatory requirements or guidelines (e.g. Swissmedic, FOPH, ISO 14155)
The conduct of an inspection follows standarised procedures:
- Pre-Inspection: inspectors provide the SP-INV of the study with an inspection agenda (e.g. purpose and scope). They might also request study documents for review
- During the inspection: at an opening meeting inspectors present the aim of the inspection, and proceed to check study documents and perform staff interviews. Inspectors end the inspection with a debriefing meeting and a presentation of findings
- Post-Inspection: inspectors forwards the SP-INV an inspection report
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Inspectors can target any establishment involved in the planning and implementation of a study (e.g. the SP-INV, CRO’s, participating study sites, partners).
Based on certain conditions, foreign RAs can conduct inspections in Switzerland. Foreign inspectors can only access documents related to the scope of the inspection.
What do I need to do?
As a SP-INV, prior to an upcoming inspection:
- Immediately notify the Site-INV about the upcoming inspection, and provide the site wiht the planned inspection agenda (e.g. purpose and scope)
- Ensure SP-INV documents are current and complete (e.g. filed in the TMF)
- Initiate inspection pre-trainings (e.g. roles and responsibilities, how to answer questions)
As a Site-INV:
- Notify study team and ensure staff is up to date and trained on study relevant tasks and responsibilities
- Ensure essential and other relevant site documents are current and complete (e.g. filed in the ISF)
Post Inspection:
- Within 30 days inspectors issue an official inspection report containing a list of findings and obligations
- As a SP-INV answer by writing an official inspection response that includes a CAPA plan and timelines until when findings will be resolved
- Inspectors review the report and either approve or request additional improvements. Adapted CAPAs must be resubmitted for approval
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- Any findings identified during the inspection are documented in an official report, which is issued by the RA
- Findings are categorised according to level of compliance with respect to RA requirements (e.g. minor, major, and critical)
- In the event of critical findings, the RA might decide to put participant recruitment on hold or define further obligatory actions
- The SP-INV of the inspected site must issue an inspection response, which contains a CAPA plan and timeline on how to handle findings
- CAPA resolutions are given specific timelines. Major and critical findings might require immediate action on the part of the study site
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
References
ICH GCP E6(R2) – see in particular guidelines
- 1.29 Inspection
- 1.6 Audit
- 5.0 Quality management
ISO 9001 – see in particular section
- QMS Requirements (access liable to costs)
ISO 19011 – see in particular section
- Guidelines for auditing management systems (access liable to costs)
Swiss Law
ClinO – see in particular articles
- Art. 46 Agency inspections
- Art. 58 FOPH inspections