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

More

Inspection follow-up:

  • 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)

More

  • 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

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
Abbreviations
  • CAPA – Corrective and Preventative Actions
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • ISF – Investigator Site File
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ 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
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Conduct

Please note: the Easy-GCS tool is currently under construction.