What is it? Why is it important?

During study conduct, the safety of study participants must be guaranteed at all times. Based on the HRA law, human studies:

  • Can only be carried out if equivalent findings cannot be obtained through other means
  • Must ensure that risks and burdens are minimised
  • Must ensure that risks and burdens are not disproportionate to any expected benefits

EC and RA (e.g. Swissmedic) only approve studies that comply with these principles. Consequently, during study conduct:

  • Participant safety is constantly monitored
  • Safety events are assessed and reported to EC/RA on an ongoing and timely required manner
  • The risk-benefit ratio of the study remains acceptable (e.g. benefits outweigh risks)
  • The study is immediately stopped once safety can no longer be guaranteed

More

The risk-benefit assessment of an ongoing study requires that physical, psychological, and social risks are included in the evaluation. All aspects considered the potential individual benefit for participants must outweigh any identified risks.

What do I need to do?

As a SP-INV and Site-INV:

  • Know and comply with safety laws and guidelines applicable to your study (e.g. safety collection, assessment and documentation procedures)
  • Comply with safety procedures described in the study protocol, including applicable local SOPs / WIs
  • Ensure staff remains trained on study safety procedures and applicable protective measures (e.g. including the risk management of the study)

As a Site-INV:

Report safety issues to the SP-INV within required timelines

As a SP-INV:

  • Reports safety issues to EC/RA within required timelines
  • Assess the risk-benefit ratio of the study on an ongoing basis. Implement as applicable risk preventive measures
  • Immediately Stop the study if participant safety can no longer be guaranteed

For more information refer to Safety and QM & Risk in this Study Guide.

More

Safety monitoring is a dynamic process. At any time during study conduct, new safety issues may become apparent. Based on newly defined safety issues, study participants must:

  • Be informed on how this might affect their safety
  • Be asked whether they would want to stay in the study.
  • In the event of an ICF adaptation due to an update in safety concerns, requires that the participant signs and re-consents to the study (e.g. signs and dates the updated ICF)

Where can I get help?

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

References

Declaration of Helsinki – see in particular principles

  • 4 Safety
  • 7-9 Protection of rights, health and interest
  • 14 Medical research and medical care
  • 16-18 Risks, burdens and benefits

ISO 14155:2020 Medical device (access liable to costs) – see in particular sections

  • 4 Summary of GCP principles
  • 6.2 Risk management
  • 7.4.4 Risk assessment process for potentially unacceptable risks

SAMS manual “Research with human subjects” – see in particular chapters

  • Chapter 4 Scientific requirements
  • Chapter 6 Assessment of risk and benefits

Swiss Law

FEDLEX – law is available online under number

  • 810.308 HRA

HRA – see in particular article

  • Art. 15 Safety and protective measures
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX - Publication Platform for Federal Laws
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instruction
Conduct ↦ Ethics and Laws ↦ Safety ↦ Requirements
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 ↦ Ethics and Laws ↦ Safety ↦ Requirements

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