Basic Flashcards

Under 21 CFR 312.64, when must an investigator report a serious adverse event to the sponsor?

Answer: Immediately, whether or not it is considered drug related

21 CFR 312.64(b) requires investigators to report any serious adverse event to the sponsor immediately, regardless of suspected causality.

Under 21 CFR 56.107, what is the minimum number of members an IRB must have?

Answer: Five

FDA regulations require each IRB to have at least five members with varying backgrounds.

What is the purpose of Form FDA 1572?

Answer: Statement of Investigator committing to comply with IND regulations

Form FDA 1572 is the Statement of Investigator, in which the investigator agrees to conduct the study under 21 CFR 312 requirements.

Under 21 CFR 312.62(c), if a marketing application is approved, how long must an investigator retain study records?

Answer: 2 years after the marketing application is approved for the indication

Investigators must retain records for 2 years after approval, or 2 years after the investigation is discontinued and FDA is notified if no application is filed or approved.

Which Belmont Report principle most directly requires fair and equitable selection of research subjects?

Answer: Justice

The principle of justice concerns the fair distribution of research burdens and benefits, which is applied through equitable subject selection.

Under 21 CFR 56.110, who may carry out an expedited IRB review?

Answer: The IRB chairperson or one or more experienced reviewers designated by the chair

Expedited review may be done by the IRB chair or by experienced IRB members the chair designates, but they cannot disapprove the research.

How quickly must a sponsor report an unexpected fatal or life-threatening suspected adverse reaction to FDA in an IND safety report?

Answer: Within 7 calendar days

21 CFR 312.32(c)(2) requires notification no later than 7 calendar days after the sponsor first receives the information.