Your Easy Guide to Clinical Studies

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:

• The Swiss law on Research involving Human Beings (HRA) and its ordinances (i.e. ClinO, ClinO-MD, HRO)
• Ethical principles such as the Declaration of Helsinki
• Guidelines such as ICH GCP, ISO 14155, ISO 20916
• If applicable, International regulatory requirements

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

 

Aspects to consider include:

• To document the safety strategy of the study in the study protocol ((e.g. documentation of safety events, the planning of interim analyses)
• To develop a safety monitoring plan

 

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

• Safety assessment: as applicable in a medicinal product study, medical device study, other clinical study, or research project
• Safety reporting: as applicable in a medicinal product study, medical device study, or research project

 

In addition, and as applicable:

• The surveillance of safety and protective measures are implemented
• An annual safety report is submitted to the Ethics Committee (EC), and if applicable, to Swissmedic (i.e. for risk-category B and C studies)

 

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

References

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