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

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 preventative action with resolution timelines)

More

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:

  • 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 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.

More

  • 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

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

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
Abbreviations
  • CAPA – Corrective and Preventive Actions
  • ClinO
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EMA – European Medicines Agency
  • FDA – Food and Drug Administration
  • FEDLEX - Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • GCP – Good Clinical Practice
  • GDP – Good Distribution Practice
  • GMP – Good Manufacturing Practice
  • GVP – Good Pharmacovigilance Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Study File
  • QM – Quality Management
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Conduct ↦ Ethics and Laws ↦ Inspections and Audits ↦ Inspection Conduct
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
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Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Inspections and Audits ↦ Inspection Conduct

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