CRA CRA Regulatory Submissions & FDA Requirements

Question 1

Which FDA regulation governs the protection of human subjects in clinical research conducted or supported by federal agencies?

Accepted Answer

45 CFR Part 46

Answer

21 CFR Part 50

Answer

21 CFR Part 312

Answer

21 CFR Part 56

Question 2

An Investigational New Drug (IND) application must be submitted to the FDA before which activity can begin?

Accepted Answer

Phase I human clinical trials

Answer

Preclinical animal testing

Answer

Protocol development

Answer

IRB review

Question 3

Which section of a New Drug Application (NDA) contains clinical study reports and individual patient data?

Accepted Answer

Module 5 — Clinical Study Reports

Answer

Module 1 — Administrative Information

Answer

Module 2 — Summaries

Answer

Module 3 — Quality

Question 4

What is the FDA's standard review period for a standard NDA submission?

Accepted Answer

10 months

Answer

6 months

Answer

18 months

Answer

24 months

Question 5

A sponsor must submit an IND safety report (IND Annual Report) to the FDA within how many months of the IND going into effect?

Accepted Answer

12 months

Answer

6 months

Answer

18 months

Answer

24 months

Question 6

Which FDA guidance document provides the framework for electronic submissions using the Common Technical Document (CTD) format?

Accepted Answer

ICH M4

Answer

ICH E6(R2)

Answer

ICH E3

Answer

ICH E9