SOCRA Basic 4

Question 1

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

Accepted Answer

Immediately, whether or not it is considered drug related

Answer

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

Question 2

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

Accepted Answer

Five

Answer

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

Question 3

What is the purpose of Form FDA 1572?

Accepted Answer

Statement of Investigator committing to comply with IND regulations

Answer

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

Question 4

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

Accepted Answer

2 years after the marketing application is approved for the indication

Answer

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.

Question 5

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

Accepted Answer

Justice

Answer

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

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Basic 4