What is it? Why is it important?
An inspection is a systematic examination of study activities conducted by regulatory authorities to verify regulatory compliance (e.g. Swissmedic, FDA, EMA).
Inspections are usually notified 4-6 weeks upfront, and conducted according to pre-set agenda (e.g. purpose and scope).
An inspection includes:
- An opening meeting
- Review of study processes and documents
- Inspection of facilities, equipment and products
- Staff interviews
- A debriefing / close out meeting with the presentation of findings
- Typically within 30 days, the authorities will issue an official inspection report with a summary of findings
- The SP-INV is required to provide an official response to the inspection report and its findings. The response is typically summarised in a CAPA format (e.g. the implementation of corrective and preventative action with resolution timelines)
Any study-related staff member or facility can be inspected (e.g. the SP-INV and if applicable ay participating Site-INV(s), study site(s), CRO’s manufacturer, other third party service providers).
Under special circumstances, foreign authorities can conduct inspections in Switzerland. Inspectors will only have access to documents related to the scope of the inspection.
Inspection can be:
- For cause (e.g. suspicion of fraud or deliberate misconduct)
- Requested based on an upcoming marketing authorisation
- With or without prior notification
What do I need to do?
As a SP-INV, notify the Site-INV(s) of an upcoming inspection, including purpose and scope. As a Site-INV, prepare the study team for the inspection.
For the inspectee procedures include:
- Prior to the inspection, review:
- Documents to ensure they are up to date, correct, and filed (e.g. TMF/ISF, SOPs, study processes)
- The correct implementation of local processes (e.g. IMP/MD handling, processing of biological material)
- Study relevant trainings and responsibilities (e.g. Site-Delegation-Log)
- Inspection requirements and management (e.g. preparation, conduct, follow-up). Train staff accordingly
- During the inspection:
- Be available and provide inspectors with required documents and fair answers
- After the inspection:
- Based on inspection findings write a Corrective and Preventative Action (CAPA) plan, adding timelines for their implementation
- Oversee and guarantee CAPA implementation, within predefined timelines
For more information refer to QM and Risks in this Study Guide.
- It is possible that an inspection notification goes directly to a study site, In this case the Site-INV must promptly inform the SP-INV of the study
- Any findings identified during the inspection are documented in an official report issued by the RAs
- Findings are categorized according to the level of compliance with regulatory requirements (e.g. minor, major, or critical findings)
- In the event of critical findings, RA may decide to suspend participant recruitment or may define further necessary actions
- CAPA resolutions are subject to specific timelines. Major and critical findings might require immediate action from the study site in order to ensure prompt corrective/preventative measures
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
Swissmedic - see in particular
- Human medicines / Clinical trials on medicinal products / GCP and GVP inspections
- Other inspections include GDP- / GMP inspections
FEDLEX – law is available online under number
- 810.305 ClinO
ClinO – see in particular articles
- Art. 46-48 Inspections and Official Measures
- Art. 58 Transplant studies FOPH inspections
- Art. 59 Transplant studies official measures