Good Clinical Practice Q&As

摘要

In this case, the protocol takes precedence, in large part because sponsors, the IRB, and others who have input on the protocol may decide, due to particular study-related factors (e.g., high risk of research), that individuals with certain levels of training be required to conduct certain study-related tasks. “In some cases, a protocol may specify the qualifications of the individuals who are to perform certain protocol-required tasks (e.g., physician, registered nurse), in which case, the protocol must be followed, even if state law permits individuals with different qualifications to perform the task (see 21 CFR 312.23(a)(6) and 312.40(a)(1)),” The FDA states in its October 2009 final guidance titled, “Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects,” “For example, if the state in which the study site is located permits a nurse practitioner or physician’s assistant to perform physical examinations under the supervision of a physician, but the protocol specifies that physical examinations must be done by a physician, a physician must perform such exams.