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

An Investigator IND is submitted when a physician-investigator initiates and conducts a study using a marketed drug for a new indication not on the label.

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

21 CFR 312.32 defines SAEs as those resulting in death, life-threatening events, inpatient hospitalization, persistent disability, congenital anomaly, or requiring medical intervention to prevent one of these outcomes.

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

Per 21 CFR 312.32(c)(2), unexpected fatal or life-threatening suspected unexpected serious adverse reactions must be reported to FDA within 7 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 312 Subpart D (Responsibilities of Sponsors and Investigators) outlines the specific obligations of clinical investigators under FDA regulations.

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

FDA requires that sub-investigators performing significant protocol tasks be listed on Form 1572, while other staff delegated tasks must appear on a site delegation log signed by the PI.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA FDA Regulations and Compliance 2