The term “investigator” as used in this protocol as well as in other study documents, refers to the investigator or authorized study personnel that the investigator has designated to perform certain duties. Sub-investigators or other authorized study personnel are eligible to sign for the investigator, except where the investigator’s signature is specifically required. The coordinating investigator will be selected before study start. The coordinating investigator will sign the clinical study report. 11.2 Study Training The sponsor will ensure that the investigator and study site personnel understand all requirements of the protocol, the investigational status of the IP, and his/her regulatory responsibilities as an investigator. Training may be provided at an investigator’s meeting, at the study site, and/or by instruction manuals. In addition, the s ponsor will be available for consultation with the investigator and will serve as the liaison between the study site a nd the sponsor. 11.3 Study Monitoring The study monitor is responsible for ensuring and verifying that each study site conducts the study according to the protocol, standard operating procedures, other written instructions/agreements, ICH GCP, and applicable national and local regulatory guidelines/requirements. The investigator will permit the study monitor to visit the study site at appropriate intervals, as described in the Clinical Trial Agreement.