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 conducted is according to the study protocol, SP-INV’s SOPs, GCP and regulatory requirements.
An inspection is announced ahead of time and based on:
- A defined agenda provided by the RA (e.g. purpose and scope)
- An opening meeting with presentation of inspection aims
- Inspection conduct (e.g. document check, staff interviews)
- Debriefing meeting with presentation of findings
- Typically, within 30 days, the RA will issue an official inspection report containing a list of findings and obligations
- The SP-INV is required to provide an official inspection response. The response includes a CAPA plan including timelines on how findings will be resolved
- In the event the response provided by the SP-INV is not approved by the RA, an adapted CAPA response must be submitted for approval
Inspection targets are any establishment involved in the planning and implementation of a study and deemed appropriate by authorities (e.g. CRO’s, study sites, SP-INV, 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?
Prior to an upcoming inspection:
- Immediately notify the Site-INV about the upcoming inspection including purpose and scope
- Ensure SP-INV documents are current and complete (e.g. TMF)
- Define required inspection pre-training (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 processes
- Ensure essential and other relevant site documents are current and complete (e.g. ISF)
- 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, 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
- 1.29 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)
ClinO – see in particular articles
- Art. 46 Agency inspections
- Art. 58 FOPH inspections