Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 102

The ICH GCP guidance (E6(R2)), as it is today, reflects the attempt to prevent harmful consequences of experimentation on humans over centuries (Chapter 1 History). In societies, there have always been someone seeking to sell the next “wonder drug” and a “scientist” who is curious about how human bodies work and how they would respond to new or modified vaccines, treatments, or potential cures. Per ICH E6(R2), the sponsor is “an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial” (ICH E6(R2) 1.53) and the investigator is “a person responsible for the conduct of the clinical trial at a trial site” (ICH E6(R2) 1.34). ICH has provided guidance on the responsibilities of the sponsor (ICH E6(R2) 5) and of the investigator (ICH E6(R2) 4). Although the sponsor and investigator essentially collaborate to create and execute a clinical trial with an aim to discover new or improved vaccines, treatments, or potential cures new treatments, the sponsor and investigator have specific and independent responsibilities that are stipulated by ICH (E6(R2)) and perhaps regional or local regulatory requirements.

In this chapter, we will present the responsibilities of sponsors and investigators in the context of the general trial process and provide the reader with references to book chapters that describe the responsibilities in greater detail. Plate 4 Individual Clinical Trial – Overview of Investigator and Sponsor Responsibilities displays the individual responsibilities in the context of the chapter content in the book and the reader may refer to the relevant sections of ICH E6(R2) for lists of the responsibilities by player.