CATO Associate Clinical Trial Operations Flashcards
6 cards from real CCA practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 6 CATO Associate Clinical Trial Operations flashcards as text
What is the primary objective of Phase I in clinical trials?
Answer: Evaluate safety and dosage in healthy volunteers
Phase I focuses on evaluating the safety, dosage range, and side effects of a new drug in a small group of participants.
What is an essential document for participant protection in a clinical trial?
Answer: Informed consent form
The informed consent form ensures participants understand the risks and procedures before joining the trial.
Which role is responsible for monitoring site compliance and data integrity?
Answer: Clinical Research Associate (CRA)
Clinical Research Associates (CRAs) ensure that clinical sites follow protocols and accurately report trial data.
Why are inclusion and exclusion criteria used in clinical trials?
Answer: To ensure consistent and safe study population
These criteria help define the study population, reduce variability, and enhance participant safety.
What is the function of a Data Safety Monitoring Board (DSMB)?
Answer: Review data for safety concerns
A DSMB independently reviews clinical trial data to ensure participant safety and trial integrity.
What must occur before a clinical trial can begin?
Answer: IRB approval
Approval from an Institutional Review Board (IRB) is required to ensure ethical standards are met.