What is it? Why is it important?

Participant identity including any medical information obtained as a result of study participation is strictly confidential.

In order to protect the identity of study participants, the Site-INV maintains a subject Identification-Log (ID-Log). The lD-Log lists the name of study participants and allots each participant a unique study-ID. All subsequent study documentation uses the study-ID as an identifier (e.g. study database, safety reporting).

Safety reporting and follow-up requires that personal data and correspondence is transmitted and exchanged between the Site-INV and SP-INV, the SP-INV (Site-INV) and EC, and if applicable SP-INV and RA (e.g. Swissmedic). In order to protect participant identity, only the study-ID can be as an identifier.

What do I need to do?

As a Site-INV you are responsible to:

  • Set-up processes that protect the identity of study participants at all times
  • Maintain a study ID-Log that is kept separate and access-protected
  • Ensure that the identity of study participants is only disclosed to study staff who need the information for the execution of their study tasks

During study monitoring the monitor needs to confirm the identity of study participants. The Site-INV must ensure that only the identity of study participants is revealed, while the identity of other hospital / site patients remain protected.

For more information on this topic refer to Monitoring in this study guide.

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 guidelines

  • 1.58 Subject identification code
  • 4.11.1 Safety reporting
  • 5.0.1 Data identification
  • 5.5.5 Use of subject ID code
  • 5.13.4 Blinded studies
  • 8.3.22 Subject ID-Log

Swiss Law

FEDLEX – law is available online under number

  • 235.1 FADP

FADP – see in particular article

  • Art. 1 Data protection aim
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FADP – Federal Act on Data Protection
  • FEDLEX – Publication Platform for Federal Laws
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Safety ↦ Safety Documentation ↦ 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): Development ↦ Safety ↦ Safety Documentation ↦ Data Protection

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