Your Easy Guide to Clinical Studies

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:
  • Processing of their Health related Personal Data (HrPD) (e.g. study data)
  • Collection of their Biological Material (BM)
  • Further-use of their data for research purposes (e.g. includes both BM and HrPD)
• 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))

As a SP-INV or Site-INV ensure:

• 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).

References

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

Swiss Law

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