CRA CRA Regulatory Submissions & FDA Requirements 1

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

45 CFR Part 46, known as the Common Rule, governs protection of human subjects in federally funded research.

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

An IND must be submitted and allowed to proceed by the FDA before a new drug can be administered to human subjects in clinical trials.

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 5 of the Common Technical Document (CTD) format contains all clinical study reports and tabulations of individual patient data.

Question 4

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

Accepted Answer

10 months

Answer

The FDA's standard review goal for an NDA is 10 months from the date of filing, while priority review is 6 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

Sponsors must submit an annual progress report to the FDA within 60 days of the anniversary date of the IND going into effect, which falls within a 12-month cycle.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA CRA Regulatory Submissions & FDA Requirements 1