SOCRA Knowledge 4

Question 1

Under 21 CFR 312.32, a sponsor must notify FDA of an unexpected fatal or life-threatening suspected adverse reaction no later than:

Accepted Answer

7 calendar days after receipt

Answer

Unexpected fatal or life-threatening suspected adverse reactions require an IND safety report within 7 calendar days.

Question 2

According to 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

If a drug is approved for the studied indication, how long must an investigator retain study records under 21 CFR 312.62?

Accepted Answer

2 years after the marketing application is approved

Answer

Records must be kept for 2 years after approval, or 2 years after the investigation is discontinued and FDA is notified if no application is approved.

Question 4

Which form does a drug study investigator sign to commit to conducting the study per the protocol and FDA regulations?

Accepted Answer

Form FDA 1572

Answer

Form FDA 1572, the Statement of Investigator, lists the investigator's commitments under the IND.

Question 5

Per ICH E6, how often should the Investigator's Brochure be reviewed and revised as necessary?

Accepted Answer

At least annually

Answer

ICH E6 states the IB should be reviewed at least annually and revised per the sponsor's written procedures.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Knowledge 4