<qa>  What is the ICH-GCP-conform?- Quality assurance and data management Design, execution and analyzation of the study is ICH-GCP-conform Good-Clinical-Practice-Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. All responsible persons are obliged to good clinical practice. All changes in study protocol are to be authorized by responsible Ethics Committee. The P.I. is responsible for source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources e.g., medical records, paper or electronic case report forms. 