Clinical Trials Flashcards
7 cards from real CNPR 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 Trials flashcards as text
What is the purpose of a wash-out period in a clinical trial?
Answer: To allow effects of a prior treatment to dissipate before starting the next treatment period
A wash-out period allows a previously administered drug to clear from the body so its effects do not carry over and confound results in the next treatment period.
Under Good Clinical Practice (GCP) guidelines, how long must trial records typically be retained after trial completion?
Answer: At least 2 years after the last marketing approval
ICH E6 GCP guidelines require essential documents to be retained for at least 2 years after the last marketing approval or after the investigational drug is discontinued.
What is the primary function of an Institutional Review Board (IRB)?
Answer: To protect the rights, safety, and welfare of human research participants
An IRB independently reviews research protocols and informed consent documents to protect the rights, safety, and welfare of human research subjects.
What is a 'serious adverse event' (SAE) in clinical trial reporting?
Answer: An adverse event that results in death, hospitalization, disability, or is life-threatening
An SAE is defined as any adverse event resulting in death, life-threatening condition, inpatient hospitalization, persistent disability, or congenital anomaly.
What does 'blinding' in a clinical trial primarily prevent?
Answer: Bias in treatment assessment and reporting
Blinding prevents knowledge of treatment assignment from influencing participant behavior or investigator assessment, thereby reducing measurement and reporting bias.
Which type of clinical trial design is most appropriate for rare diseases with very small patient populations?
Answer: N-of-1 or adaptive trial design
N-of-1 designs or adaptive trial designs are particularly valuable for rare diseases because they maximize information from small populations through flexible statistical approaches.
What is the significance of a p-value less than 0.05 in clinical trial results?
Answer: There is a statistically significant difference unlikely due to chance alone
A p-value < 0.05 indicates there is less than a 5% probability the observed result occurred by chance, meeting the conventional threshold for statistical significance.