Guidance for Industry on Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects." This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.