Your Easy Guide to Clinical Studies

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 4 ordinances:
  • The Clinical Trials Ordinance (ClinO)
  • The Human Research Ordinance (HRO)
  • The Clinical Trials with Medical Device Ordinance (ClinO-MD)
  • The Organisation Ordinance (OrgO-HRA)

 

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. based on an audit-trail)
• Access to study data must be protected with regulated access control measures (e.g. access rights)

 

The FADP

• 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 processed

As a SP-INV,

• Ensure data confidentiality and traceability
• Limit the number of staff given access to study data (e.g. regulated access to data entry)
• Access should be based on required circumstances necessary to perform delegated task(s)
• Code study data at the time of data collection in order to protect participant identity
• Guarantee that no data has been collected without the participant consent

 

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

 

External Links

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 Purpose
• Art. 2 Scope

SCTO Regulatory Affairs – see in particular

• RAW Issue 1, April 2019,  Essential information on data protection

References

ICH GCP E6(R2) – see in particular guidelines

• 2.11 Confidentiality of records
• 4.9 Records and reports

Swiss Law

HRA – see in particular chapter and articles

• Chapter 10 Transparency and data protection
• Art. 8 Right to receive information
• Art. 16 Informed consent
• 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