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2 Regulatory Environment
P. Michael Dubinsky
GCP Key Point
Regulatory authorities along with medical institutions and professional groups form a network of controls which set the boundaries for human biomedical clinical trials thereby ensuring that GCP is followed.
2.1 Introduction
Is it idealistic to think that all clinical research whether commercial, academic, governmental or otherwise will be conducted under ethical guidelines and according to best scientific and professional practices such as GCP? Unfortunately idealism has not always been the guiding force in human biomedical research and along the way governmental and professional oversight has been implemented to ensure that abuses are avoided. This chapter explores the regulatory environment that has evolved to oversee human biomedical clinical trials.
2.2 Objective
To describe the nature and scope of controls that are in place to ensure that human biomedical clinical trials are conducted in a manner which ensures the protection of human subjects participating in them and the scientific integrity of the trial plan. Understanding the nature, scope and reach of the regulatory controls as well as their enforceability is essential to applying the GCP principles.
2.3 Regulatory Matrix
The regulatory environment within which human biomedical clinical trials are conducted is a matrix composed of: (i) the policies, laws, and regulations which describe the requirements and guidance; (ii) the governmental jurisdictions (Federal, State, Country, Region e.g. EU) which are responsible for implementing the requirements through regulatory authorities; (iii) nongovernmental organizations, e.g. Academic Medical Centers (AMCs), which both sponsor clinical trials and set their own internal standards for how clinical trials will be conducted; and (iv) the professional organizations (e.g. WHO, WMA) which support, define, and interpret the requirements, standards, and guidelines for their professional members.
It is not always clear whether this matrix works together under a planned scenario but the end result is that if a commercial sponsor, medical establishment, or individual practitioner wishes to conduct
