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 14155, ISO 20916).
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:
- 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)
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
HRA – see in particular articles
- Art. 4 Primacy of individual interests
- Art. 11-14 Protection of participants
- Art. 15 Safety and protective measures