Storage and data protection
ADVERSE EVENTS, RECRUITMENT
This study adheres to legal regulations for the storage, registration, transfer and evaluation of data according to the Austrian Act on Pharmaceutical Products and data protection law (AMG). By signing the consent form, potential participants are informed and agree to the following:Data obtained during the course of this clinical trial will be treated as strictly confidential, and passed on exclusively to the following persons without mentioning names (pseudonymised): the sponsor of the trial for scientific evaluation and assessment of adverse events as well as the biostatistician responsible for outcome assessment. Investigators responsible for the recruitment and data collection during the trial as well as the lab personnel responsible for outcome parameter measurements may work with personalized data (not pseudonymized) when required.Monitoring and auditing personnel, employees of national and foreign health authorities as well as members of the competent ethics committee may also gain access to personal data at the study centre for auditing and quality control purposes.The participant is entitled to terminate her participation in the clinical trial at any time without stating reasons and without future consequences or disadvantages. However, we are required by law to store and in individual cases inspect personal data even after trial dropout for a period of time as defined in the AMG.