What is it? Why is it important?

Health-related personal data including data collected during a study are considered sensitive data. Based on the law, the confidentiality and identity of study participants must always be protected.

 

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 provisions are implemented during double-blind studies, where the IMP/IMD-log log must be kept inaccessible to the study team (e.g. study staff, Site-INV). Unblinding is only performed during an emergency situation

 

Participant identifiers include 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. consecutive inclusion numbers, in a multi-centre study add a code für study site)
  • Ensure participant coding and confidentiality is already considered 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

References

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
Abbreviations
  • 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
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • pCRF – paper Case Report Form
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • RAW – Regulatory Affairs Watch
  • SCTO - Swiss Clinical Trial Organisation
Development ↦ Data Management ↦ Database Development ↦ Data Confidentiality
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Data Management ↦ Database Development ↦ Data Confidentiality

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