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.

Requirements include that:

  • Study participants give prior consent to the:
    • Processing of their personal data
    • Collection of their biological material
    • Further use of their data for research purposes (e.g. includes both biological material and health-related data)
  • Data is protected against unauthorised processing (e.g. through the installation and use off required IT and infrastructures)
  • Participants have the right to information regarding the processing of their data
  • The privacy and confidentiality of participant data is protected at all times
  • The transmission of data and biological material to foreign authorities and international organisations is regulated

What do I need to do?

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 data, including the handling of their biological material (e.g. confidentiality, data entry, storage, 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 data / sample sharing, ensure appropriate agreements are in place between the SP-INV (e.g. responsible for the study and its data) and other researcher(s) (e.g. DTUA / MTA).

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

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

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 235.1 FADP

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CAPA – Corrective and Preventive Action
  • CTU – Clinical Trials Unit
  • DTUA – Data Transfer User Agreement
  • FADP – Federal Act on Data Protection
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • IT – Information Technology
  • MTA – Material Transfer Agreement
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • WI – Working Instruction
Conduct ↦ Ethics and Laws ↦ Study Conduct ↦ Data Protection
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Study Conduct ↦ Data Protection

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