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Phases of a Clinical Trial – Post Test

Phases of a Clinical Trial Module 6: Difference between Cohort, Case-Control, and Cross-Sectional Studies Phases of a Clinical Trial – Post Test

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Question 1 of 12

1. Question
Choose all the following essential elements of a clinical trial. (Select all that apply.)
- Human Subjects
- Intervention(s)
- Prospective in nature with follow-up observations
- A good scientific question
- Uncertainty/equipoise in the scientific community
- An appropriate level of risk-benefit for the interventions
- A study design that is appropriate to the scientific quest
Question 2 of 12

2. Question
A favorable risk-benefit setting requires that the intervention be risk-free or that there be a guarantee of benefit.
- True
- False
Question 3 of 12

3. Question
What is the primary objective of a Phase I clinical trial?
- To estimate biologic activity or effect (efficacy) and to assess the rate of adverse events (toxicity).
- To assess effectiveness in comparison to standard treatment or placebo.
- To assess how well a drug or procedure can be tolerated in humans and to determine a reasonable dose or technique.
- Long-term surveillance (monitoring) and to assess long-term morbidity and mortality.
Question 4 of 12

4. Question
The maximum tolerated dose (MTD) = dose level at which no more than 1 patients has a dose limiting toxicity out of
- 5 patients
- 3 patients
- 4 patients
- 6 patients
Question 5 of 12

5. Question
What is the primary objective of a Phase II clinical trial?
- Long-term surveillance (monitoring) and to assess long-term morbidity and mortality
- To estimate biologic activity or effect (efficacy) and to assess the rate of adverse events (toxicity).
- To assess how well a drug or procedure can be tolerated in humans and to determine a reasonable dose or technique.
- To assess effectiveness in comparison to standard treatment or placebo.
Question 6 of 12

6. Question
In a Phase II two-stage design, which of the following is true:
- It assumes a binary measure of efficacy (e.g. response: yes, no)
- It is an open-label study
- The investigator needs to establish the response rate which is too low and the minimal response rate needed to proceed
- All of the above
Question 7 of 12

7. Question
What is the primary objective of a Phase III clinical trial?
- Long-term surveillance (monitoring) and to assess long-term morbidity and mortality.
- To assess effectiveness in comparison to standard treatment or placebo.
- To estimate biologic activity or effect (efficacy) and to assess the rate of adverse events (toxicity).
- To assess effectiveness in comparison to the placebo.
Question 8 of 12

8. Question
A single masked trial is a trial in which neither the study participant nor any of the investigators is aware of the intervention received.
- True
- False
Question 9 of 12

9. Question
A placebo can be used as a control arm when the investigator feels that it would be a better to use as a comparison than the standard therapy for the disease/condition under investigation.
- True
- False
Question 10 of 12

10. Question
What is the primary objective of a Phase IV clinical trial?
- To estimate biologic activity or effect (efficacy) and to assess the rate of adverse events (toxicity).
- To assess effectiveness in comparison to standard treatment or placebo.
- Long-term surveillance (monitoring) and to assess long-term morbidity and mortality.
- To assess how well a drug or procedure can be tolerated in humans and to determine a reasonable dose or technique.
Question 11 of 12

11. Question
A cohort study can be a clinical trial?
- True
- False
Question 12 of 12

12. Question
Interventional trials occur when a drug, device, or other treatment is applied to human participants in a research setting so that researchers can evaluate potential effects of the intervention on specified outcomes (biomedical or health-related).
- True
- False

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About the DCOC

The Data Coordinating and Operations Center (DCOC) is the component within the NIH Environmental influences on Child Health Outcomes (ECHO) Program that provides operational coordination for the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN). This coordination also includes technical instruction, data coordination as well as quality control and assurance.

ECHO ISPCTN Network Sites

ECHO IDeA States Pediatric Clinical Trials Network

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