What is it? Why is it important?
The Swiss law regulates the processing of sensitive data, which includes health related data. Study data is health related data and must comply with regulatory protection requirements (e.g. local/cantonal and national data protection law).
Requirements include that:
- Study participants are informed about (e.g. PIS) and give prior consent (e.g. ICF) to the:
- Data is protected against unauthorised processing (e.g. access rights)
- Participants have the right to information regarding the processing of their data
- The privacy and confidentiality of participant data is protected at all times (e.g. data coding and anonymisation)
- The export of HrPD and BM to external researchers, foreign authorities, and international organisations is regulated (e.g. Data Transfer Agreement (DTA) and Material Transfer Agreement (MTA))
What do I need to do?
- To comply with data protection laws
- Study staff is trained on the correct handling and processing of participant HrPD and BM (e.g. confidentiality, data entry, storage (e.g. server), and export requirements)
- Processes (e.g. SOP, WI) are in place in the event of data protection breach, including the implementation of corrective measures (e.g. CAPAs)
- CAPAs are implemented in order to prevent data breach in the future (e.g. example of a data breach would be the accidental disclosure of participant personal data to outsiders not involved in the study)
In the event of sharing HrPD and BM, ensure appropriate agreements are in place (e.g. DTA / MTA).
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
- 5.15 Record access
ISO 14155:2020 Medical device (access liable to costs) – see in particular section
- 7.7 Subject privacy and confidentiality of data
HRA – see in particular articles
- Art. 41-43 Transfer, export, storage
- Art. 57 Duty of confidentiality
- Art. 60 Transmission to foreign authorities / organisations
ClinO – see in particular article
- Art. 18 Storage of health related personal data
ClinO-MD – see in particular article
- Art. 8 Data processing in electronic systems and information sharing
FADP – see in particular articles
- Art. 4 Principles
- Art. 6 Cross-border disclosure
- Art. 7 Data security
- Art. 8 Right to information
- Art. 10 Processing by third parties