Basic↦Data Handling↦Regulatory Requirements↦Swiss Law
What is it? Why is it important?
Various laws and ordinances regulate and address data protection issues:
- The Federal Act on Data Protection (FADP)
- Data protection in clinical research is governed by the Human Research Act (HRA) including its 2 ordinances:
Based on the HRA:
- Data confidentiality must be guaranteed at all times
- Any recorded study data including implemented changes as well as persons that document the data must be traceable (e.g. through the availability of an audit trail)
- Access to study data must be protected with regulated access control measures
- Aims to protect the privacy and the fundamental rights of persons and their processed data.
- Defines data processing as any operation that handles personal data in particular the collection, storage, use, revision, disclosure, archiving or destruction of data
- Applies to any data that is processes from natural- and legal persons
- Private person
- Federal bodies
The Federal Data Protection and Information Commissioner (FDPIC) is the competent authority for data processing by federal bodies and private persons, including enterprises.
Supervision regarding any data processed by cantonal or communal authorities is regulated by the cantonal and communal data protection commissioners.
What do I need to do?
As a SP-INV, ensure data confidentiality:
- Limit the number of staff given access to study data (e.g. regulated access to data entry, study documents are safely locked away)
- Access should be based on required circumstances necessary to perform delegated task(s). This will ensure purposeful and appropriate data handling
- Code study data at the time of data collection in order to protect participant identity (e.g. see swissethics guideline on how to code study participants)
Participants freely consent to the use of their data by signing a consent form (ICF), and have the right to:
- Be informed and view any data collected on their behalf
- Have their data corrected in the event of incorrect entries
- Dissent to their data being used for further research
- Have their data anonymised upon revocation of consent
For more information refer to Ethics and Laws in this Study Guide.
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
Swissethics – see in particular
- Topics / Other topics / Coding of trial subjects accepted by swissethics
Federal Act on Data Protection (FADP) – see in particular
- Art. 1 Aim
- Art. 2 Scope
ICH GCP E6(R2) – see in particular guidelines
- 2.11 Confidentiality of records
- 4.9 Records and reports
HRA – see in particular articles
- Art. 8 Right to receive information
- Art. 17 Consent to further use for research
ClinO – see in particular article
- Art. 9 Consequences of revocation of consent
HRO – see in particular article
- Art. 10. Consequences of revocation of consent