CATO Associate Clinical Trial Operations 1 — Questions and Answers
Question 1: What is the primary objective of Phase I in clinical trials?
- Test long-term efficacy
- Determine side effects in large populations
- Evaluate safety and dosage in healthy volunteers (Correct answer)
- Market the drug
Correct 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.
Question 2: What is an essential document for participant protection in a clinical trial?
- Site monitoring log
- Informed consent form (Correct answer)
- Budget agreement
- Protocol deviation memo
Correct answer: Informed consent form
The informed consent form ensures participants understand the risks and procedures before joining the trial.
Question 3: Which role is responsible for monitoring site compliance and data integrity?
- Principal Investigator
- Regulatory Affairs Manager
- Clinical Research Associate (CRA) (Correct answer)
- Data Entry Clerk
Correct answer: Clinical Research Associate (CRA)
Clinical Research Associates (CRAs) ensure that clinical sites follow protocols and accurately report trial data.
Question 4: Why are inclusion and exclusion criteria used in clinical trials?
- To increase enrollment numbers
- To allow unrestricted participation
- To ensure consistent and safe study population (Correct answer)
- To determine funding needs
Correct answer: To ensure consistent and safe study population
These criteria help define the study population, reduce variability, and enhance participant safety.
Question 5: What is the function of a Data Safety Monitoring Board (DSMB)?
- Recruit participants
- Market the study
- Monitor site budgets
- Review data for safety concerns (Correct answer)
Correct answer: Review data for safety concerns
A DSMB independently reviews clinical trial data to ensure participant safety and trial integrity.
Question 6: What must occur before a clinical trial can begin?
- Public announcement
- Site selection
- IRB approval (Correct answer)
- Contract with CRO
Correct answer: IRB approval
Approval from an Institutional Review Board (IRB) is required to ensure ethical standards are met.
CATO Associate Clinical Trial Operations 1
What is the primary objective of Phase I in clinical trials?