Which of the following areas is not the scope of clinical trials?
A. new drugs or new combinations of drugs or new use of existing drugs
B. new ways of doing surgery & new medical devices
C. new ways to change behaviors to improve health & new ways to improve the quality of life for people with acute or chronic illnesses
D. how to make more money
________ is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
A. GLP
B. GCP
C. GMP
D. GAP
______ is an independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
A. IRP
B. IAB
C. IRB
D. IIB