The information Data Protection and Archiving Act is a law that brings together provisions relating to :
- Public information and access to official documents (transparency).
- The protection of personal data.
- Archiving of official documents.
The General Data Protection Regulations ("GDPR") came into force on 24 May 2016, but from this date a transition period of 2 years is provided for. The Privacy Commission, companies and organisations have until 25 May 2018 to comply with the requirements of the GDPR.
Legal basis for medical research:
- The Declaration of Helsinki from 1964 onwards.
- Since 1990, ICH Good Clinical Practice (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
- In Switzerland and Europe the laws do not directly mention data management, however data management is subject to compliance with Good Clinical Practice (GCP) and the ICH.
- On the other hand, the DPA (Federal Data Protection Act) and the OLPD (Ordinance on the Federal Data Protection Act) apply to data management procedures, as does the HRA, which has been in force since January 2014.
- Since 2008, ECRIN (The European Clinical Research Infrastructures Network) has been developing European standards in accordance with the GCP.
- The SCTO (Swiss Clinical Trial Organisation) is currently finalising recommendations for data management of clinical studies at the federal level.