CTA Regulatory Guidelines and Compliance 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, which document must a sponsor submit to the FDA before initiating a clinical investigation of an unapproved drug in the US?
- New Drug Application (NDA)
- Investigational New Drug Application (IND) (Correct answer)
- Biologics License Application (BLA)
- Abbreviated New Drug Application (ANDA)
Correct answer: Investigational New Drug Application (IND)
An Investigational New Drug (IND) application must be submitted to the FDA under 21 CFR Part 312 before a sponsor can ship an unapproved drug across state lines for clinical investigation.
Question 2: Which ICH guideline specifically addresses the statistical principles for clinical trials?
- ICH E6
- ICH E8
- ICH E9 (Correct answer)
- ICH E10
Correct answer: ICH E9
ICH E9 provides guidance on statistical principles for clinical trials, covering design, conduct, analysis, and reporting.
Question 3: A clinical site fails to report a serious adverse event to the IRB within the required timeframe. This constitutes a:
- Protocol deviation
- Protocol violation (Correct answer)
- Reportable event waiver
- Safety signal
Correct answer: Protocol violation
Failure to report a serious adverse event to the IRB within the required timeframe is a protocol violation because it breaches a mandatory regulatory or protocol requirement.
Question 4: The Declaration of Helsinki primarily provides ethical guidance for:
- Animal research studies
- Medical research involving human subjects (Correct answer)
- Laboratory analytical testing
- Drug manufacturing processes
Correct answer: Medical research involving human subjects
The Declaration of Helsinki is a set of ethical principles adopted by the World Medical Association governing medical research involving human subjects.
Question 5: Which regulation governs the protection of human research subjects and requires IRB review for federally funded studies in the US?
- 21 CFR Part 312
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 11
- 45 CFR Part 164
Correct answer: 45 CFR Part 46
45 CFR Part 46 (the Common Rule) establishes requirements for IRB review and informed consent protections for federally funded human subjects research.
Question 6: Under EU Clinical Trials Regulation 536/2014, what is the maximum timeframe for sponsors to report unexpected serious adverse reactions (USARs) that are fatal or life-threatening?
- 7 days (Correct answer)
- 15 days
- 30 days
- 45 days
Correct answer: 7 days
Under EU CTR 536/2014, fatal or life-threatening unexpected serious adverse reactions must be reported to the EMA within 7 days.
Question 7: A sponsor-investigator is best defined as an individual who:
- Monitors trials on behalf of a pharmaceutical company
- Both initiates and conducts the clinical investigation (Correct answer)
- Reviews protocols on behalf of the FDA
- Manages IRB submissions for academic institutions
Correct answer: Both initiates and conducts the clinical investigation
A sponsor-investigator is an individual who both initiates and actually conducts a clinical investigation, taking on the combined responsibilities of sponsor and investigator.
CTA Regulatory Guidelines and Compliance 2
Under 21 CFR Part 312, which document must a sponsor submit to the FDA before initiating a clinical investigation of an unapproved drug in the US?