CATO Associate Clinical Trial Operations Flashcards
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Read the first 7 CATO Associate Clinical Trial Operations flashcards as text
What is the role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend trial continuation or termination
A DSMB is an independent group that periodically reviews unblinded data to protect participant safety and trial integrity.
Which term refers to the complete set of standard operating procedures, instructions, and specifications for conducting a clinical trial?
Answer: Quality Management System
A Quality Management System (QMS) encompasses the SOPs, processes, and quality standards that govern trial conduct.
Under FDA regulations, an Investigational New Drug (IND) application must be submitted before:
Answer: Administering an investigational drug to humans in the US
An IND application must be filed and allowed to go into effect before any investigational drug is administered to human subjects in the US.
In clinical trial operations, what does 'SUSAR' stand for?
Answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction, requiring expedited reporting to regulatory authorities.
Which statistical concept refers to the probability of correctly detecting a true treatment effect if one exists?
Answer: Statistical power
Statistical power (1 - beta) is the probability that a trial will detect a true treatment effect of a given size.
A sponsor's written procedures for monitoring clinical trials are formally documented in which type of document?
Answer: Standard Operating Procedures (SOPs)
SOPs provide written instructions for carrying out sponsor monitoring and other trial functions in a consistent, compliant manner.
What is the primary purpose of a pre-study site assessment visit?
Answer: To evaluate the site's suitability, resources, and capability to conduct the trial
A pre-study (feasibility or qualification) visit assesses whether a site has the staff, facilities, and patient population needed to conduct the trial.