Your Easy Guide to Clinical Studies

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.

 

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).

 

As a SP-INV you are expected to have appropriate knowledge and skills regarding data security and data protection (e.g. data protection act) or ensure compliance by calling in appropriate expertise.

 

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

ClinO – see in particular article

• Art. 6 paragraph 1 letter c Data security and data protection

ClinO-MD – see in particular article

• Art. 5 paragraph 1 letter d Data security and data protection

HRO – see in particular article

• Art. 4 paragraph 1 letter d Data security and data protection