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:
    • 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))

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 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


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
  • 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
  • HRA – Human Research Act
  • HrPD – Health related Personal Data
  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

Please note: the Easy-GCS tool is currently under construction.