Your Easy Guide to Clinical Studies

During study conduct, the rights, safety, and well-being of study participants must remain a primary concern to be guaranteed at all times.

 

During study conduct and participant recruitment:

• Study related tasks are only implemented after participants have given their consent (e.g. however special procedures apply for studies in emergency situations)
• Participant safety always takes precedence over research interests (e.g. ethical dilemma). Thus, the risk-benefit ratio of the study must remain favourable
• Participant privacy and confidentiality are protected at all times (e.g. data coding and anonymization, database access rights)

 

In the event of vulnerable study participants, consent procedures must be adapted and comply with the law (e.g. emergency situations, children, adolescents, adult lacking capacity, pregnant women)

As a SP-INV and Site-INV:

• Comply with the Ethics Committee (EC) / RA (e.g. Swissmedic) approved study protocol (e.g. study eligibility criteria, screening procedures, study intervention and study design, safety reporting procedures interim analysis)

 

At participant recruitment:

• Selection from the target-population must be fair and non-biased (e.g. on vulnerability, privilege or other factors)
• Inform participants of their study role and duties
• Know the participant`s rights, that include to:
  • Ensure participants freely decide whether they want to  consent to study participation (i.e. freely sign the Informed Consent Form (ICF))
  • Inform participants about the study (PIS), especially potential study risks (e.g. orally and in writing 
  • Inform participants about conditions related to genetic testing
  • Respect the participant`s wish whether to be informed or not informed about data concerning them
  • Ensure participants know their right to withdraw from the study at any time, without consequences

References

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

• 4 GCP summary
• 5.8 Informed consent
• 6.2 Risk management
• 7.4.4 Adverse events risk assessment
• 9.2.4 Monitoring General
• Annex B Investigator’s brochure
• Annex H Application of ISO 14971

SAMS manual “Research with human subjects” – see in particular chapters

• Chapter 4 Scientific requirements
• Chapter 5 Selection of study participants
• Chapter 6 Assessment of risk and benefits
• Chapter 8 Information and consent
• Chapter 9 Respect of participants

Swiss Law

HRA – see in particular articles

• Art. 6 Non discrimination
• Art. 7 Consent
• Art. 8 Right to receive information
• Art. 12 Risks and burdens
• Art. 16 Informed consent
• Art. 21-24 Research involving children, adolescents and adults lacking capacity
• Art. 30-31 Research in Emergency situations
• Art. 15-17 Clinical Trials in Emergency Situations

ClinO – see in particular articles

• Art. 7 Information
• Art. 7a Information in cases of genetic testing
• Art. 7b Information in cases of prenatal risk assessment
• Art. 8 Exceptions to written form
• Art. 9 Consequences of revocation of consent

ClinO-MD – see in particular article

• Art. 3 Applicable provisions (b,d)

HRO – see in particular articles 

• Art. 8 Information
• Art. 8a Information in cases of genetic testing
• Art. 8b Information in cases of prenatal risk assessment