SOCRA FDA Regulations and Compliance 2

Question 1

Under 21 CFR Part 312, which IND application type is used when a sponsor wants to conduct a clinical investigation using a legally marketed drug for a new indication?

Accepted Answer

Investigator IND

Answer

Emergency IND

Answer

Treatment IND

Answer

Research IND

Question 2

What is the FDA's regulatory definition of a 'serious adverse event' (SAE) under 21 CFR Part 312.32?

Accepted Answer

Any AE resulting in death, hospitalization, disability, or congenital anomaly

Answer

Any AE that requires dose reduction

Answer

Any Grade 3 or higher toxicity per CTCAE

Answer

Any AE that causes a protocol deviation

Question 3

A sponsor must notify FDA of an unexpected fatal or life-threatening SUSAR within how many calendar days of first receiving information?

Accepted Answer

7 calendar days

Answer

10 calendar days

Answer

15 calendar days

Answer

30 calendar days

Question 4

Which FDA regulation specifically governs the obligations of clinical investigators in conducting clinical trials?

Accepted Answer

21 CFR Part 312 Subpart D

Answer

21 CFR Part 50

Answer

21 CFR Part 54

Answer

21 CFR Part 314

Question 5

What does FDA require regarding the delegation of protocol tasks to study staff not listed on the FDA Form 1572?

Accepted Answer

Sub-investigators must be added to Form 1572; other staff appear on a delegation log

Answer

All tasks must be performed only by the principal investigator

Answer

Any licensed healthcare professional may perform tasks without documentation

Answer

Tasks may be delegated verbally without additional documentation

Question 6

Under FDA regulations, a CRO that assumes sponsor obligations must do which of the following?

Accepted Answer

Ensure that any uncanceled obligations revert back to the sponsor

Answer

Obtain approval from the IRB before assuming responsibilities

Answer

Submit a CRO registration to FDA before conducting any trial activities

Answer

File an amendment to the IND listing the CRO as co-sponsor

Question 7

Which of the following best describes FDA's 'clinical hold' authority under 21 CFR 312.42?

Accepted Answer

An FDA order to delay or suspend a clinical investigation for safety or compliance reasons

Answer

An order to pause subject enrollment pending safety review

Answer

A request for additional preclinical data before IND approval

Answer

A temporary suspension of IND review while FDA requests more information