Clinical Practices Guidelines 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 Clinical Practices Guidelines flashcards as text
Which regulatory framework provides the foundational international standard for the design, conduct, and reporting of clinical trials?
Answer: ICH E6(R2) Good Clinical Practice
ICH E6(R2) GCP is the internationally accepted standard for clinical trial conduct, accepted by regulatory authorities in the US, EU, and Japan.
Under FDA regulations, an IND (Investigational New Drug) application must be submitted before which of the following?
Answer: Initiating clinical studies in humans in the United States
An IND must be in effect before a sponsor may ship an investigational drug across state lines or begin clinical studies in humans in the US.
According to ICH E6, what must an investigator do if a subject experiences an adverse event that is both serious and unexpected?
Answer: Report it to the sponsor immediately and follow up with a written report
Serious and unexpected adverse events must be reported to the sponsor immediately, who then assesses whether expedited regulatory reporting is required.
What is the purpose of the Declaration of Helsinki in the context of clinical trials?
Answer: To provide ethical principles for medical research involving human subjects
The Declaration of Helsinki, adopted by the World Medical Association, provides foundational ethical principles governing medical research involving human subjects.
A CTA notices that a site has been administering study drug to subjects after the protocol-specified window for dosing has closed. This is best classified as:
Answer: A protocol deviation that must be documented and reported
Administering study drug outside the protocol-specified window is a protocol deviation that must be documented and reported to the sponsor and, if required, to the IRB.
Which of the following best describes the role of a Data Safety Monitoring Board (DSMB)?
Answer: To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination
A DSMB (or Data Monitoring Committee) independently reviews unblinded safety and efficacy data at interim points to protect subject safety and trial integrity.
Under 21 CFR Part 312, how long must an investigator retain clinical trial records after the investigation is discontinued or completed?
Answer: 2 years
Under 21 CFR 312.62, investigators must retain records for at least 2 years after the date on which a marketing application is approved, or 2 years after the investigation is discontinued.