Regulatory Guidelines and Compliance Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Guidelines and Compliance flashcards as text
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?
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.
Which ICH guideline specifically addresses the statistical principles for clinical trials?
Answer: ICH E9
ICH E9 provides guidance on statistical principles for clinical trials, covering design, conduct, analysis, and reporting.
A clinical site fails to report a serious adverse event to the IRB within the required timeframe. This constitutes a:
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.
The Declaration of Helsinki primarily provides ethical guidance for:
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.
Which regulation governs the protection of human research subjects and requires IRB review for federally funded studies in the US?
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.
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?
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.
A sponsor-investigator is best defined as an individual who:
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.