1. What type of clinical trial compares a new treatment to an existing standard treatment?
A) Open label trial
B) Single blind trial
C) Double blind trial
D) Randomized controlled trial
2. Which phrase best describes the purpose of a placebo in a clinical trial?
A) To test for side effects of a treatment
B) To act as a comparison against the experimental treatment
C) To determine the efficacy of a treatment
D) To establish adverse event profiles
3. Which type of clinical trial requires participants and investigators to remain unaware of treatment assignment?
A) Open label trial
B) Single blind trial
C) Double blind trial
D) Crossover trial
4. In which phase of clinical trials is a treatment first tested in humans?
A) Phase 0
B) Phase 1
C) Phase 2
D) Phase 3
5. What type of clinical trial designs assess more than two treatment groups?
A) Parallel design
B) Crossover design
C) Factorial design
D) All of the above
6. What methodology is used in clinical trials to randomly assign participants to treatment groups?
A) Blinding
B) Stratification
C) Randomization
D) Block randomization
7. Why is informed consent regarded as ethically important in clinical trials?
A) To protect participants and their rights
B) To maintain blinding and objectivity of trial
C) To empower researchers over participants
D) To ensure generalizability of findings
8. What is the primary purpose of a pilot clinical trial?
A) Establish safety and efficacy of a treatment
B) Determine optimal trial procedures and assessments
C) Generate hypotheses for future trials
D) Screen potential participants
9. Who is responsible for monitoring safety data during a clinical trial?
A) Sponsor
B) Principal investigator
C) Data safety monitoring board
D) Institutional review board
10. What document must be prepared prior to initiating a clinical trial?
A) Informed consent form
B) Study protocol
C) Case report form
D) Statistical analysis plan
11. What organizational body regulates clinical trials in the United States?
A) FDA
B) NIH
C) IRB
D) HIPAA
12. What is the purpose of stratification in randomized clinical trials?
A) Create balanced groups for baseline characteristics
B) Standardize assessments over time
C) Maintain blinding between treatment groups
D) Control for placebo effects
13. What statistical methodology is used to analyze clinical trial results?
A) Kaplan-Meier survival analysis
B) Risk-benefit analysis
C) Intention-to-treat analysis
D) All of the above
14. Which statement regarding clinical trial phases is FALSE?
A) Phase 1 trials enroll healthy volunteers
B) Phase 2 trials have randomized controls
C) Phase 3 trials evaluate efficacy
D) Phase 4 trials examine long term outcomes
15. When are clinical trials considered to be low versus high risk?
A) Risk level is determined by investigators
B) Risk is assessed by data safety monitoring boards
C) Low risk trials do not require safety monitoring
D) Risk depends on trial oversight and monitoring processes
16. Which group is not routinely included in clinical trial recruitment?
A) Elderly patients
B) Pediatric patients
C) Pregnant women
D) Prisoners
17. Which of the following practices poses an ethical issue in clinical trials?
A) Use of placebos
B) Post-trial access to treatment
C) Payments to participants
D) Random treatment assignment
18. All of the following are objectives of post-market monitoring EXCEPT:
A) Examine treatment effectiveness over longer term
B) Identify adverse events not detected in earlier trials
C) Generate additional efficacy data for new indications
D) Assess safety based on standard of care
19. What methodology is used to systematically assess benefits and risks of a treatment?
A) Meta-analysis
B) Intention-to-treat analysis
C) Crossover design
D) Risk-benefit analysis
20. What phase of drug development involves first-time testing in humans?
A) Pre-clinical studies
B) Phase 0 clinical trials
C) Phase 1 clinical trials
D) Phase 2 clinical trials
21. Informed consent must ensure participants understand all of the following EXCEPT:
A) Trial purpose and procedures
B) Potential benefits of the research
C) Compensation for participation
D) Risks and discomforts involved
22. When is the first analysis of efficacy data conducted in a clinical trial?
A) After half of participants complete treatment
B) At preliminary pre-specified timepoint
C) After all participants complete treatment
D) At discretion of sponsor and investigators
23. What trial design compares multiple treatment groups versus a single control group?
A) Parallel design
B) Crossover design
C) Stratified design
D) Factorial design
24. What statistical approach is used to control for multiplicity when making multiple comparisons?
A) Intention-to-treat analysis
B) Per protocol analysis
C) Bonferroni correction
D) Stratified analysis
25. Which statement about placebo controls is FALSE?
A) Placebos help rule out psychological factors
B) Placebos must be clinically indistinguishable from treatment
C) Placebos lack ethical justification in trials
D) Placebos are legally mandated by regulatory bodies
26. Who serves as the independent ethics committee for clinical trials?
A) Institutional Review Board
B) Data Safety Monitoring Board
C) Steering Committee
D) Executive Committee
27. What type of clinical study evaluates different doses of a treatment?
A) Dose-response study
B) Bioequivalence study
C) Bioavailability study
D) Cross-titration study
28. What statistical metric represents the probability a significant result is due to chance?
A) p-value
B) Power
C) Effect size
D) Hazard ratio
29. What characteristics must be measured and reported in all clinical trial participants?
A) Demographics
B) Clinical assessments
C) Diagnostic evaluations
D) All of the above
30. Who is responsible for reporting adverse events to regulatory authorities?
A) Institutional Review Board
B) Principal investigator
C) Data safety monitoring board
D) Sponsor
31. What ethical principle ensures research maximizes benefit while minimizing harm?
A) Equipoise
B) Utility
C) Informed consent
D) Justice
32. What is the primary purpose of clinical trial monitoring?
A) Ensure data quality and integrity
B) Evaluate participant safety
C) Generate efficacy findings
D) Prevent treatment contamination
33. How many phases must a drug or device typically pass through to receive FDA approval?
A) 4
B) 5
C) 6
D) Depends on product and risks
34. What trial design compares treatment groups receiving multiple interventions?
A) Crossover design
B) Parallel design
C) Factorial design
D) Stratified design
35. What best describes the purpose of an IRB?
A) Protect rights and welfare of human subjects
B) Ensure study feasibility and oversight
C) Manage clinical trial operations and conduct
D) Analyze and report clinical trial findings
36. Which analysis compares intention-to-treat and per protocol results?
A) Sensitivity analysis
B) Subgroup analysis
C) Non-inferiority analysis
D) Equivalence analysis
37. What statistical metric measures how well a continuous variable can categorize outcomes?
A) Relative risk
B) Likelihood ratio
C) Receiver operating characteristic curve
D) Kaplan-Meier curve
38. Which two phases primarily evaluate safety and efficacy?
A) Phase 1 and Phase 2
B) Phase 2 and Phase 3
C) Phase 1 and Phase 4
D) Phase 3 and Phase 4
39. An interim analysis may be conducted to assess for what purpose?
A) Futility
B) Safety concerns
C) Either a or b
D) Efficacy
40. What regulatory body overseas clinical trials in the European Union?
A) EMA
B) MHRA
C) TGA
D) HC