Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 105
9.2.2 Sponsor and Investigator Responsibilities in the Context of the Clinical Trial Process
ОглавлениеThis chapter describes the responsibilities of sponsors and investigators in the context of the general clinical trial process (Plate 4 Individual Clinical Trial – Overview of Investigator and Sponsor Responsibilities). While some activities are necessarily sequential (e.g., IRB/IEC approval/favorable opinion of a protocol prior to consenting a human research subject), some activities may occur concurrently for efficiency (e.g., selecting investigators and selecting a CRO for data management).