What is it? Why is it important?
Health-related personal data including data collected during a study are considered sensitive data, and are given special protection under the law (e.g. data protection act).
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 provision are implemented during blinded studies, where the log must be kept inaccessible to the study team (e.g. study staff, Site-INV). Unblinding is only performed during an emergency situation by a person outside the study
Participant identifiers include first- and last 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. run consecutive screening numbers, adapt number of digits based on the expected number of planned participants, in a multi-centre study add a digit für study site)
- Ensure participant coding and confidentiality is already implemented 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
Your local CTU can support you with experienced staff regarding this topic.
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
ICH GCP E6(R2) – see in particular guideline
- 2.11. Confidentiality of records
HRA – see in particular chapter and article
- Chapter 10: Transparency and data protection
- Art. 16 Informed Consent