1
What information should be
provided to an IRB for review at
the initiation of a study? Choose
the best response.
O A. A synopsis of the study and an outline of
the advertisement to recruit subjects,
including how much they will be paid.
OB. The informed consent form.
OC. The study protocol (and amendments),
the information to be given to the subject
(informed consent, advertisements), the
Investigator Brochure (or drug label), any
other relevant safety information, and an
outline of the qualifications of the
Investigator.
OD. The study protocol (and amendments)
and the Investigator Brochure.