Development↦Data Handling↦Study Database↦Data Confidentiality
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.
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
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.
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
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