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 is conducted according to the EC approved study protocol, ICH GCP, the study relevant SOPs, the law (e.g. Swiss law), and other applicable regulatory requirements or guidelines (e.g. Swissmedic, EC, FOPH, ISO 14155)

 

The conduct of an inspection follows standarised procedures (e.g. Swissmedic GCP inspection): 

  • Pre-Inspection: inspectors send an announcement letter to the SP-INV and request the relevant documents. Inspectors define an inspection plan (e.g. purpose, scope and agenda) to be presented to the Sp-INV. Inspectors may decide to adjust the plan during the inspection.  
  • During the inspection: at an opening meeting inspectors present the purpose of the inspection and proceed to check study documents, perform staff interviews and a facility tour. Inspectors end the inspection with a closing meeting. At the meeting a summary of findings are presented
  • Post-Inspection: after assessing and approving the SP-INVs CAPA plan, inspectors forward the signed inspection report to the SP-INV (e.g. the SP-INV pays for the inspections)

More

Inspectors can target any establishment involved in the planning and implementation of a study (e.g. the SP-INV, CRO’s, participating study sites, 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?

As a SP-INV, prior to an upcoming inspection:

  • Immediately notify the Site-INV about the upcoming inspection, and provide the site with the planned inspection agenda (e.g. purpose and scope)
  • Ensure SP-INV documents are current and complete (e.g. filed in the TMF)
  • Initiate inspection pre-trainings (e.g. roles and responsibilities, how to answer questions, dos and dont`s)

 

As a Site-INV:

  • Notify study team and ensure staff is up to date on the site delegation log and trained on study relevant tasks and responsibilities
  • Ensure essential and other relevant site documents are current and complete (e.g. filed in the ISF)

 

Post Inspection:

  • Within 30 days inspectors issue an official inspection report containing a list of findings and obligations
  • As a SP-INV answer by writing an official inspection response that includes a CAPA plan and timelines until when findings will be resolved
  • Inspectors review the response and associated CAPA plan, and either approve or request additional improvements and/or documents. Adapted CAPAs must be resubmitted for approval

More

  • Any findings identified during the inspection are documented in an official report, which is issued by the RA (e.g. Swissmedic)
  • Findings are categorised according to level of compliance with respect to RA requirements (e.g. minor, major, and critical - according to EMA`s grading of inspection findings)
  • In the event of critical findings, the RA might decide to put participant recruitment on hold or define further obligatory actions

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 (access liable to costs) – see in particular section

  • QMS Requirements

ISO 19011 (access liable to costs) – see in particular section

  • Guidelines for auditing management systems

EMA - see in particular document on

Procedures for reporting of GCP inspections requested by the committee for Medical Products for Human Use (CHMP)

  • Appendix 5: Grading of inspection findings

 

Swiss Law

ClinO – see in particular articles

  • Art. 46 Agency inspections
  • Art. 58 FOPH inspections
Abbreviations
  • CAPA – Corrective and Preventative Actions
  • ClinO – Clinical Trials Ordinance
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EMA – European Medicines Agency
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • 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
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Conduct

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