CRA CRA Regulatory Submissions & FDA Requirements 1 — Questions and Answers
Question 1: Which FDA regulation governs the protection of human subjects in clinical research conducted or supported by federal agencies?
- 21 CFR Part 50
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 312
- 21 CFR Part 56
Correct answer: 45 CFR Part 46
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?
- Preclinical animal testing
- Phase I human clinical trials (Correct answer)
- Protocol development
- IRB review
Correct answer: Phase I human clinical trials
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?
- Module 1 — Administrative Information
- Module 2 — Summaries
- Module 5 — Clinical Study Reports (Correct answer)
- Module 3 — Quality
Correct answer: Module 5 — Clinical Study Reports
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?
- 6 months
- 10 months (Correct answer)
- 18 months
- 24 months
Correct answer: 10 months
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?
- 6 months
- 12 months (Correct answer)
- 18 months
- 24 months
Correct answer: 12 months
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.
Question 6: Which FDA guidance document provides the framework for electronic submissions using the Common Technical Document (CTD) format?
- ICH E6(R2)
- ICH M4 (Correct answer)
- ICH E3
- ICH E9
Correct answer: ICH M4
ICH M4 provides the framework for organizing regulatory submissions using the Common Technical Document (CTD) format accepted by FDA, EMA, and other agencies.
CRA CRA Regulatory Submissions & FDA Requirements 1
Which FDA regulation governs the protection of human subjects in clinical research conducted or supported by federal agencies?