Conduct↦Ethics and Laws↦Inspections and Audits↦Inspection Conduct
What is it? Why is it important?
An inspection is a systematic review 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 a pre-set agenda (e.g. purpose and scope).
An inspection includes:
- An opening meeting
- Review of study processes (e.g. investigational product handling, unblinding, analysis method, Risk Control Measures,) and documentation thereof (e.g. quality processes such as WIs and SOPs, Logs)
- Inspection of facilities equipment (e.g. infrastructure and maintenance)
- Staff interviews (e.g. responsibilities and training)
- A debriefing / close out meeting with the presentation of findings
Inspection follow-up:
- 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 preventive action with resolution timelines)
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Any study-related staff member or facility can be inspected (e.g. the SP-INV and if applicable any participating Site-INV(s), study site(s), CRO’s manufacturer, other third party service providers, such as data management, statistics, laboratory, pharmacy).
Under special circumstances, international authorities can conduct inspections in Switzerland. Inspectors will only have access to documents related to the scope of the inspection.
Inspection can be:
- Routine
- 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 inspected party, the inspection can be divided into three main phases.
1. Prior to the inspection
- Review Study documents / quality processes (e.g. essential documents, study protocol, SOPs, training- and delegation-logs) to ensure they are complete, up to date, correct, and filed in the TMF/ISF
- Check the correct implementation of local quality processes (e.g. IMP / IMD handling, safety reporting, handling of biological material)
- Be familiar with upcoming inspection requirements and management (e.g. preparation, conduct, follow-up). Train staff accordingly
2. During the inspection
- Be available and provide inspectors with required documents and fair answers
3. After the inspection
- Based on inspection findings write a Corrective and Preventive Action (CAPA) plan, adding respective responsibilities and timelines for CAPA implementation
- Retain CAPA-oversight to ensure CAPA measures are implemented as planned and within predefined timelines
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- It is possible that an inspection notification is submitted directly to a participating study site. In that case the Site-INV must promptly inform the SP-INV of the study
- Findings, identified during the inspection, are documented in an official "inspection report" issued by the inspecting Regulatory Authority (AR) (e.g. Swissmedic), and forwarded to the inspected party
- Findings are categorized according to the level of compliance with regulatory requirements (i.e. minor, major, or critical findings)
- In the event of critical findings, RA may decide to suspend participant recruitment or may define further necessary actions
- The CAPA plan submitted by the inspected party, must be approved by RAs
- Major and critical findings may require immediate action, from a study site, to ensure prompt CAPA implementation. This may become necessary to protect participant safety and/or data quality
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External links
Swissmedic - see in particular
- Human medicines / Clinical trials on medicinal products / GCP and GVP inspections
- Other inspections include GDP- / GMP inspections
Swiss Law
ClinO – see in particular articles
- Art. 46-48 Inspections and Official Measures
- Art. 58 Transplant studies FOPH inspections
- Art. 59 Transplant studies official measures
ClinO-MD – see in particular article
- Art. 3f Inspections