Confidentiality
The Investigator will maintain appropriate medical and research records for this trial, in compliance with ICH-GCP and regulatory and institutional requirements for the protection of confidentiality of subjects. The Principal Investigator, Sub-investigators, and Clinical Research Nurses or Coordinators will have access to the records. The Principal Investigator will permit authorized representatives of the Sponsor and regulatory agencies to examine clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety and progress. The Investigator ensures anonymity of the participants; participants will not be identified by names in any documents leaving the study site. Subject confidentiality will be ensured by utilizing subject identification codes and the subject code list will be maintained and kept locked under the responsibility of the Principal Investigator. Access to uncoded data including the code list will be restricted to members of the study team and will be allowed for the purposes of monitoring, audits, and inspections and, if required, for representatives of the responsible insurance company in a liability case. It will be kept in locked cupboards at the department of Urology of the Spitalzentrum Biel.