What is it? Why is it important?
Study insurance provides financial protection for the SP-INV including compensation for participants should they suffer harm as a result.
- Is required for all studies
- Is either covered through the insurance of the hospital or an additional third-party insurance is required
- Must cover any claims arising from a period for up to 10 years after study completion.
The SP-INV is responsible to provide applicable study insurance.
If required, the SP-INV is responsible to provide financial compensations to study participants, including Site-INVs or its institution against claims arising from the study.
Exceptions are claims that arise from Site-INV malpractice and/or negligence.
What do I need to do?
Based on your study, make yourself familiar with insurance requirements at your institution.
Address issues such as:
- Does your hospital provide insurance that covers clinical studies? If not provided by the hospital, you need to acquire additional third-party insurance
- Include in your EC/RA submission package a certificate of insurance which covers patients claims including patient injuries and damage to properties for the entire trial
- When submitting your study to the EC/RA include proof of insurance (e.g. third-party insurance certificate)
For more information refer to Ethics and Laws in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Insurance template
ICH GCP E6(R2) – see in particular guidelines
- 5.8.1 Insurance
- 8.2.5 Essential documents
ISO 14155:2020 Medical devices - see in particular section (access liable to cost)
- 5.6.2. Ethics submission (access liable to costs)
Declaration of Helsinki – see in particular principle
- 15 Subject compensation
HRA – see in particular article
- Art. 19 and 20 Coverage
ClinO – see in particular articles
- Art. 13 Requirement for liability coverage
- Art. 14 Protection of the injured party
- Annex 3 - 1.14/2.15/3.13/4.7 Ethics application
HRO – see in particular article
- Annex 2 - 1.6/8.8 Ethics application