Data protection and verification
According to the Personal Data Act (523/1999) private and sensitive information can be collected from study subjects to research purposes only if written informed concent has been unambigiously given by study subject. A Description of the Scientific Research Data File form must be completed for all clinical trials with medicinal products conducted in Finland. The description includes detailed information about the study to the trial subject and must be available for every subject. The Notification to the Data Protection Ombudsman letter and the Notification of Transfer of Personnel Data outside the EU or EEA form must be completed and submitted to the Data Protection Ombudsman ahead of time, latest 30 days before collecting and saving the data at issue.
All subjects participating in clinical trials must be informed about the intended use of information and data about them. Participants, as patients, are entitled to access the information and data collected about them. Subjects participating in clinical trials in Finland must provide written informed consent stating explicitly the right of the regulatory authorities and sponsors’ representatives to check and verify the data. At the same time the subject may also consent to the transfer of the data to other countries including non-EU/EEA states.
Finnish medical authorities have the right to check and verify the authenticity of the research data during and after the trial by comparing participants’ patient records to the research data based on their jurisdiction (Regulation 1/2007, updated version 2/2012). If foreign regulatory authorities intend to inspect the study site and study documentation, the sponsor has to inform Fimea about the planned inspection in writing within 7 days of receiving this information. Sponsor’s representatives can also check and verify the authenticity of study documentation by comparing participants’ patient records to the recorded research data. Verifications done by other than Finnish medical authorities happen under the supervision and at the responsibility of the investigator responsible for the trial.