What is it? Why is it important?

Research with human participants:

  • Can only be carried out if equivalent findings cannot be obtained through other means (i.e. research and ethics)
  • Require that risks and burdens to study participants 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 a study or research project (i.e. risk-benefit ratio, participant risk-benefit)


The aim of safety laws is to ensure that the rights, well-being, and safety of study participants have the highest priority.


The safety framework includes:

What do I need to do?

As a SP-INV, make yourself familiar with safety requirements and its terminologies when conducting research in humans.


Aspects to consider include:


Based on your study, the following safety tasks are implemented during study conduct:


In addition, and as applicable:


Upon study completion, a clinical study report, including the study’s safety information is submitted to EC, and if applicable,to Swissmedic.

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 1 Glossary
  • 2.3 The rights, safety, and well-being of the trial subjects

Declaration of Helsinki – see in particular

  • Risks, Burdens and Benefits

ICH - E2APharmacovigilance – see in particular

  • Clinical safety data management: definitions and standard for expedited reporting
  • II Safety definitions and terminology


Swiss Law

HRA – see in particular articles

  • Art. 4 Primacy of individual interests
  • Art. 11-14 Protection of participants
  • Art. 15 Safety and protective measures
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • GCP  –  Good Clinical Practice
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor Investigator
Development ↦ Management ↦ Study Safety ↦ Requirement

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Safety ↦ Requirement

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