Organizational framework
ICH
ADVERSE EVENTS, RECRUITMENT
Organizational/regulatory project management, safety management, monitoring and data management are performed by the Münchner Studienzentrum (MSZ), Technical University of Munich, School of Medicine. An independent safety monitoring board (SMB) is established. The underlying principles for the SMB are ethical and safety aspects for the patients. The SMB examines whether the conducting of the study is still ethically justifiable, whether safety of the patients is ensured and whether the process of the study is acceptable. For this, the SMB is informed regularly about patient recruitment and observed safety advents. Serious adverse events (SAEs) are recorded in a study-specific safety form and transferred into a safety database by the safety management, which processes further SAE documentation in written form to the SMB, the Investigator, the ethics committee and regulatory authority (BfArM) according to applicable law.All study procedures agree with the guidelines of Good Clinical Practice (GCP) of the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the principles of the Declaration of Helsinki. All participating investigators agreed to adhere to the instructions and procedures described in the study protocol and thereby to adhere to the principles of ICH-GCP. All members of the safety board are independent from the sponsor. The current approved protocol version is 5.0 (amendment 3, 21.09.2020). All protocol versions are available in German language at nikolai.jung@tum.de.