Information to Study Personnel. The investigator is responsible for giving information about the study to all staff members involved in the study or in any element of patient management, both before starting the practical performance of the study and during the course of the study (e.g., when new staff become involved). The investigator must ensure that all study staff members are qualified by education, experience, and training to perform their specific responsibilities. The monitor is responsible for explaining the protocol to all study staff, including the investigator, and for ensuring their compliance with the protocol.
Information to Study Personnel. Each investigator is responsible for giving information about the study to all staff members involved in the study or in any element of patient management, both before starting the practical performance of the study and during the course of the study (eg, when new staff become involved). Each investigator must assure that all study staff members are qualified by education, experience, and training to perform their specific responsibilities. These study staff members must be listed on the study center authorization form, which includes a clear description of each staff member’s responsibilities. This list must be updated throughout the study, as necessary..The study monitor is responsible for explaining the protocol to all study staff, including each investigator, and for ensuring their compliance with the protocol. Additional information will be made available during the study when new staff become involved in the study and as otherwise agreed upon with either the investigator or the study monitor.
