What is it? Why is it important?

Various laws and ordinances regulate and address data protection issues:

  • The Federal Act on Data Protection (FADP)
  • Data protection in clinical research is governed by the Human Research Act (HRA) including its 2 ordinances:
    • The Clinical Trials Ordinance (ClinO)
    • The Human Research Ordinance (HRO)

Based on the HRA:

  • Data confidentiality must be guaranteed at all times
  • Any recorded study data including implemented changes as well as persons that document data must be traceable (e.g. through the availability of an audit trail)
  • Access to study data must be protected with regulated access control measures

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The FADP

  • Aims to protect the privacy and the fundamental rights of persons and their processed data.
  • Defines data processing as any operation that handles personal data in particular the collection, storage, use, revision, disclosure, archiving or destruction of data
  • Applies to any data that is processes from natural- and legal persons
    • Private person
    • Federal bodies

The Federal Data Protection and Information Commissioner (FDPIC) is the competent authority for data processing by federal bodies and private persons, including enterprises.

Supervision regarding any data processed by cantonal or communal authorities is regulated by the cantonal and communal data protection commissioners.

What do I need to do?

To ensure data confidentiality:

  • Limit the number of staff given access to study data (e.g. access to data entry, study documents are safely locked away)
  • Access should be based on required circumstances necessary to perform delegated task(s). This will ensure purposeful and appropriate data handling
  • Code study data at the time of data collection in order to protect participant identity (e.g. see swissethics guideline on how to code study participants)

Participants:

  • Freely consent to the use of their data by signing the study informed consent form
  • Hold rights regarding the use of their data

For more information refer to Ethics and Laws in this Study Guide.

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Participants have the right to:

  • Be informed and view any data collected on their behalf
  • Have their data corrected in the event of incorrect entries
  • Dissent to their data being used for further research
  • Have their data anonymised upon revocation of consent

Where can I get help?

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

External Links

The Federal Council – see in particular

  • FADP – Federal Act on Data Protection

Swissethics see in particular

  • Coding and storage subject information – Coding of trial subjects

Swiss Clinical Trial Organisation – see in particular

  • Regulatory Affairs Watch, Issue 1, April 2019 – Essential information on data protection

References

ICH GCP E6(R2) – see in particular guidelines

  • 2.11 Confidentiality of records
  • 4.9 Records and reports

Swiss Law

HRA – see in particular articles

  • Art. 8 Right to receive information
  • Art. 17 Consent to further use for research

ClinO – see in particular article

  • Art. 9 Consequences of revocation of consent

HRO – see in particular article

  • Art. 10. Consequences of revocation of consent
Abbreviations
  • ClinO – Clincal Trials Ordinance
  • CTU – Clinical Trials Unit
  • FADP – Federal Act of Data Protection
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
Basic ↦ Data Handling ↦ Regulatory Requirements ↦ Swiss Law
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): Basic ↦ Data Handling ↦ Regulatory Requirements ↦ Swiss Law

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