What is it? Why is it important?

Safety and Protective Measures (SPM) are activities implemented without delay to ensure the protection of study participants including other involved persons against:

  • Suspected new risks potentially able to jeopardize their safety

Based on safety concerns, the implementation of SPMs are required, defined, and documented for both HRO and ClinO studies.

During study conduct, the SP-INV can decide to include a Data Safety Monitoring Board (DSMB). Based on data review and risk analysis, the DSMB can provide support regarding the optimal implementation of SPM.

What do I need to do?

As a Project-Leader of an HRO research project, report any immediate SPMs to EC (via BASEC):

  • Within 7 days, and describe:
    • Circumstances that led to the implementation of SPM
    • The nature of the SPMs

As a Site-INV of a ClinO study, report any immediate SPM and its root cause to:

  • The SP-INV within 24 hours
  • EC via BASEC within:
    • 7 days, for IMP studies
    • 2 days, for in vitro diagnostic IMD studies

As a SP-INV of a ClinO or ClinO-MD study, report any immediate SPM and its root cause to:

  • EC via BASEC, and
  • Swissmedic for risk category B and C studies within:
    • 7 days for IMP studies
    • 2 days, for IMD studies
    • 24 hours if the termination / interruption of an IMD study was due to safety reasons

For investigational studies of risk category A, report to Swissmedic via the:

  • Pharmacovigilance reporting system for studies with an IMP
  • Materiovigilance reporting system for studies with an IMD

More

Reports should include a detailed description of the nature and circumstances that required the implementation of SPM.

In the event of multi-centre EU or EEA studies, the SP-INV must also notify all other participating ECs within the same deadlines.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Templates and checklists / Notifications

Swissmedic – see in particular

  • Human medicine
    • Clinical trials on medicinal products
    • Safety measures in clinical trials
  • Medical devices
    • Clinical trials
    • Submissions during ongoing clinical trials

References

ISO 14155:2020 Medical device (access liable to cost) – see in particular section

  • 3.46 Serious health threat

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

ClinO – see in particular article

  • Art. 37 Notification of safety and protective measures

ClinO-MD – see in particular article

  • Art. 34 Reporting of safety and protective measures

HRO – see in particular article

  • Art. 20 Notification of safety and protective measures
Abbreviations
  • AE – Adverse Event
  • BASEC - Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • DSMB – Data Safety Monitoring Board
  • EC – Ethics Committee
  • EEA – European Environment Agency
  • EU – European Union
  • FEDLEX – Publication Platform for Federal Laws
  • HRO – Human Research with the Exception of Clinical Trials
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISO - International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SPM – Safety and Protective Measures
Conduct ↦ Safety ↦ Safety and Protective Measures ↦ Procedures
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 ↦ Safety ↦ Safety and Protective Measures ↦ Procedures

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