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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
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
FEDLEX – law is available online under number
- 235.1 FADP
FADP – see in particular article
- Art. 1 Data protection aim