What is it? Why is it important?

Health-related personal data including data collected during a study are considered sensitive data, and are given special protection under the law (e.g. data protection act).


Based on the law, the confidentiality and identity of study participants must be protected at all times.


Standard procedures to follow include:

  • No participant identifiers are entered in the study database or on applicable paper documents (eCRF and pCRF)
  • Participants are allotted specific and individualised study-IDs. An access protected list available at the study site, match study-IDs with participant identity (e.g. participant Identification-Log).
  • Access to study data is restricted to study staff. Special provision are implemented during blinded studies, where the log must be kept inaccessible to the study team (e.g. study staff, Site-INV). Unblinding is only performed during an emergency situation by a person outside the study



Participant identifiers include first- and last name, address, and date of birth. Omitting them, however, does not guarantee participant anonymity. If special conditions require that participant identifiers are documented in the study database, require prior EC approval.



What do I need to do?

As a SP-INV:

  • Define a participant coding system for your study (e.g. run consecutive screening numbers, adapt number of digits based on the expected number of planned participants, in a multi-centre study add a digit für study site)
  • Ensure participant coding and confidentiality is already implemented at study screening
  • Generate a participant identification-log that matches participant identifiers (name and date of birth) with their allotted study ID-code
  • Ensure the log is kept access protected at the study site and guarded against accidental disclosure and loss
  • Ensure access to study data is only granted to study staff who need the information to perform delegated study tasks


Guaranteeing data confidentiality is not a trivial task. It might be advisable to consult applicable experts (e.g. EC, project manager, data manager).

Where can I get help?

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

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

External Links

Swissethics – search in particular

  • Coding of trial subjects accepted by swissethics

FADP – Federal Act on Data Protection

SCTO Regulatory Affairs – see in particular

  • RAW Issue 1, April 2019,  Essential information on data protection


ICH GCP E6(R2) – see in particular guideline

  • 2.11. Confidentiality of records

Swiss Law

HRA – see in particular chapter and article

  • Chapter 10: Transparency and data protection
  • Art. 16 Informed Consent
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • FADP – Federal Act on Data Protection
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ID – Identifier
  • pCRF – paper Case Report Form
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • RAW – Regulatory Affairs Watch
  • SCTO - Swiss Clinical Trial Organisation
Development ↦ Data Handling ↦ Database Development ↦ Data Confidentiality

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): Development ↦ Data Handling ↦ Database Development ↦ Data Confidentiality

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