Ethics approval and consent to participate
death
ADVERSE REACTIONS, ADVERSE EVENTS
Before the start of the trial, the trial protocol, informed consent document, and any other appropriate documents are submitted to the independent Ethics Committee (EC) as well as to the competent federal authority (BfArM). A written favorable vote of the EC and an (implicit) approval by the competent higher federal authority are a prerequisite for initiation of the clinical trial. The statement of EC should contain the title of the trial, the trial code, the trial site, and a list of reviewed documents. It must mention the date on which the decision was made and must be officially signed by a committee member. Before the first patient is enrolled in the trial, all ethical and legal requirements must be met. All planned substantial changes (see §10, (1) of German GCP-Regulation) are to be submitted to EC and the competent federal authority in writing as amendments. They have to be approved by the EC and the competent federal authority. The Coordinating Investigator or the NCT Trial Center, and if applicable the investigator(s) are keeping a record of all communication with the EC and the regulatory authorities. Pursuant to the German Drug Law (AMG) and the GCP Regulation, the EC and the competent higher federal authority are informed of all suspected unexpected serious unexpected adverse reactions (SUSARs) and all AEs resulting in death or being life-threatening, which occur during the trial. Both institutions are informed in case the benefit-risk assessment did change or any other new and significant hazards for patients’ safety or welfare did occur. Furthermore, a report on all observed serious adverse events (SAEs) is submitted once a year (Development Safety Update Report (DSUR)). The EC and the regulatory authorities must be informed of the end of the trial. They have to be provided with a summary of trial results within one year after the end of the clinical phase (LPLV).