Ethical and legal aspects
SECONDARY
All the procedures set out in the trial protocol are designed to ensure that all persons involved in the trial abide by Good Clinical Practice (GCP) and the ethical principles described in the current version of the Declaration of Helsinki. The trial is carried out in keeping with local legal and regulatory requirements. The Coordinating Investigator ensures that all trial personnel are adequately trained and maintains a list to whom he has delegated significant trial-related duties.Before being admitted to the clinical trial, all patients must consent in writing to their participation after having understood the nature, scope, and possible consequences of the clinical trial. Patients are requested to consent to biobanking and to secondary use of their pseudonymized data for yet not determined further scientific analyses. The data obtained in the course of the trial are treated pursuant to the General Data Protection Regulation (EU-DSGVO, EU 2016/679) and the Data Protection Law of the Federal State (Landesdatenschutzgesetz), and the § 40 (2a) AMG. For protection of these data, organizational procedures are implemented to prevent the distribution of data to unauthorized persons.All planned substantial changes to the study (protocol amendments) are to be submitted to the EC and the competent federal authority requesting their approval. Records of relevant communication with the EC and the regulatory authorities are kept by the coordinating investigator.