What information should be provided to an IRB for review at the initiation of a study? Choose the best response.
A. A synopsis of the study and an outline of the advertisement to recruit subjects, including how much they will be paid.
B. The informed consent form.
C. 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 lnvestigator.
D. The study protocol (and amendments) and the Investigator Brochure.
Answers
Answer:
I'm giving my own point.
sorry
The IRB should confirm that information regarding payment to participants, including the methods, amounts, and schedule of payments to study participants, is justified by the protocol and set forth in the written Informed Consent Form and any other written information provided to participants.
C. 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.
Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission. Approved: the application is approved as submitted. The approval date is the date of the IRB review.
The documents reviewed should include the complete documents received from the clinical investigator, such as the protocol, the investigator's brochure, a sample consent document, and any advertising intended to be seen or heard by prospective study subjects.