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

24 hours after receipt

Answer

15 calendar days after receipt

Answer

30 calendar days after receipt

Question 2

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

Accepted Answer

Five

Answer

Three

Answer

Four

Answer

Seven

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

5 years after study close-out

Answer

15 years after the last subject visit

Answer

Until the sponsor notifies the IRB

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 1571

Answer

Form FDA 3454

Answer

Form FDA 3455

Question 5

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

Accepted Answer

At least annually

Answer

Only when a new protocol is written

Answer

Every three years

Answer

Only after marketing approval

Question 6

Which type of submission may an IRB approve through expedited review?

Accepted Answer

Minor changes to previously approved research

Answer

Initial review of a greater-than-minimal-risk drug trial

Answer

A study involving prisoners with more than minimal risk

Answer

Any study the sponsor requests to be fast-tracked

Question 7

Under 21 CFR Part 54, an investigator's equity interest in a publicly traded sponsor must be disclosed when it exceeds:

Accepted Answer

$50,000

Answer

$25,000

Answer

$10,000

Answer

$100,000

What Practice Test Geeks adds beyond an AI chat for SOCRA