What is it? Why is it important?

Health-related data including data collected within a study is considered sensitive data. Consequently, this type of data is given special protection under the law.

As a result, participant confidentiality and their identity should be protected at all times:

  • No participant identifiers are entered in the study database (eCRF)
  • No participant identifiers are entered on pCRF
  • Participants are allotted study specific IDs. A list securely separated from the study database match study IDs with participant identity
  • Access to study data is restricted to study staff who need the information in order to perform delegated study tasks

In the event special study requirements require the need for participant identifiers to be documented in the database, prior EC approval must be sought.

More

Obvious participant identifiers are first name, last name, address and date of birth. Omitting them, however, does not guarantee participant anonymity.

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

What do I need to do?

  • Define a coding system by which participants are coded when recruited for the study
  • Generate a participant log list which is a document where participant identifiers (name and date of birth) are matched with their allotted study code
  • In the database (CRF) only study codes are used to list individually recruited participants

The log is also called a participant identifier list and should be protected against accidental disclosure or loss:

  • Ensure the list is securely stored in an access restricted location
  • Allow access only to staff requiring participant identifiers to perform any delegated study tasks

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

The Federal Council – see in particular

  • FADP – Federal Act on Data Protection

Swiss Clinical Trial Organisation – see in particular

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

Swissethics see in particular

  • Coding and storage subject information – Coding of trial subjects and storage of subject identification list

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
  • ID – Identifier
  • pCRF – paper Case Report Form
Development ↦ Data Handling ↦ Study Database ↦ Data Confidentiality
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 ↦ Data Handling ↦ Study Database ↦ Data Confidentiality

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