What is it? Why is it important?

The aim of safety laws is to ensure that the rights, well-being, and safety of study participants are given highest priority. In other words, the interest, health and welfare of an individual human being must always prevail over the interests of science and society.

The safety framework includes applicable Swiss laws, its ordinances, including international guidelines (e.g. ICH GCP, Declaration of Helsinki, ISO).

According to study type, different laws, regulations and guidelines apply (e.g. ClinO, Clino-MD, HRO).

Studies with participants:

  • May only be carried out if equivalent findings cannot be obtained through other means
  • Require that risks and burdens are minimised as far as possible
  • Must ensure that likely risks and burdens, as far as possible, are not disproportionate to the expected benefits of the study

Competent Swiss authorities include:

  • Swissmedic
  • FOPH / SECB / FOEN

What do I need to do?

Human research must comply with laws and regulations. Consequently, as a SP-INV or Site-INV:

  • Be familiar with laws, regulations and guidelines that apply to your study
  • Document in the study protocol how you plan to guarantee the safety of participant
  • Define required safety procedures to be followed during study conduct (e.g. SOP, WI)
  • Ensure study staff is trained and comply with:
    • Safety laws and regulations
    • Study safety specific SOPs / WIs
  • Acquire a GCP certificate that teaches about required international guidelines, and the safe conduct of humans studies
  • For Medical Device (MD) studies, ensure ISO 14155 is available and complied with at your site (access liable to costs)

More

In order to ensure ongoing compliance with laws and guidelines during study conduct, implement relevant standardised procedures.

Main safety procedures include how to:

  • Inform participants about the study including safety issues (e.g. PIS. ICF)
  • Standardise the collection, assessment, and documentation of safety events
  • Report safety events to EC/RA (e.g. Swissmedic)
  • How to define and implement a Data and Safety Monitoring Board (e.g. provide support regarding safety decisions)

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 guideline

  • 2 The principles of ICH GCP

Declaration of Helsinki – see in particular

  • Risks, Burdens and Benefits

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

  • 4 GCP principles

ISO 20916:2019 In vitro diagnostic medical device (access liable to costs) – see in particular

  • good study practice

Swiss Law

FEDLEX – law is available online under number

  • 810.30 HRA

HRA – see in particular articles

  • Art. 4 Primacy of individual interests
  • Art. 11-14 Protection of participants
  • Art. 15 Safety and protective measures
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • GCP – Good Clinical Practice
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • MD – Medical Device
  • PIS – Participant Information Sheet
  • SP-INV – Sponsor Investigator
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SECB – Swiss Expert Committee for Biosafety
  • WI – Working Instructions
Basic ↦ Safety ↦ Safety Laws ↦ Aim
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): Basic ↦ Safety ↦ Safety Laws ↦ Aim

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