Changes to a study protocol, via a protocol amendment, can be implemented at the site as soon as it is submitted to the IRB. O A. TRUE Ro B. FALSE 2 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. O B. The informed consent form. O C. The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the In 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,
Answers
Answer:
Protocol Amendment: Change in Protocol"
A sponsor of an IND application is expected to submit a protocol amendment in cases when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study.
1. TRUE
2. Option C is the correct answer.
The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the In drug label), any other relevant safety information, and an outline of the qualifications of the Investigator
A protocol amendment is a change to some aspect of the study. Amendments must be approved by the IRB before they can be implemented, unless there is an immediate safety concern for participants.
The IRB needs to be assured that the research is
1) of sound design, given the proposed use of human subjects.
2) that there is equitable selection of subjects.
3) that there is a reasonable balance in the risks and benefits to the participants; and
4) that the informed consent process is appropriate and comprehensive.
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