Development↦Management↦Study Safety↦Requirement
What is it? Why is it important?
Research with human 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 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 highest priority
The safety framework includes:
- The Swiss law on Research involving Human Beings (HRA) and its ordinances (e.g. 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
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:
- The documentation of safety issues in the study protocol
- To establish 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:
- The surveillance regarding safety and protective measures are implemented
- An annual safety report is submitted to the Ethics Committee (EC) and if applicable 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 Swissmedic.
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
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