Clinical Trials - Quiz
Clinical Trials Knowledge Quiz
Test your knowledge on clinical trials with this engaging quiz that covers essential concepts from different phases to adverse events. Whether you are a student, researcher, or simply have an interest in clinical research, this quiz will challenge your understanding and enhance your knowledge.
- 10 carefully crafted questions
- Immediate feedback on your answers
- Expand your understanding of clinical trial terminology and practices
1. Which one of the Clinical Trial Phases is also called the "Confirmatory" Phase?
Phase I
Phase II
Phase III
Phase IV
2. Studies designed to compare a new treatment for a disease or condition with an existing treatment (usually the standard one) are named:
Superiority Trials
Cross-over Trials
Sequential Trials
Equivalence Trials
3. In order to take part in a clinical trial, an informed consent is not always required.
True
False
4. Select the correct statements:
Phase IV of Clinical Trials begins after drug approval.
"Investigational Medicinal Product” refers in some regulatory settings (EU) to all the treatments used in a trial: placebo, active comparators or the “experimental” product.
In a double-blind clinical trial, the subjects do not know to which group they have been assigned, but investigators do.
Every clinical trial must be approved by national and/or regional regulatory authorities as well as independent local ethics committees or institutional review boards in the countries where the trial takes place.
5. The researcher who is involved in running a clinical trial is called:
Sponsor
Investigator
Subject
Monitor
6. An Adverse Event of Special Interest (AESI) is not always serious.
True
False
7. What does the "U" from "SUSAR" stand for?
Unwanted
Unexpected
Unfortunate
Universal
8. SUSARs that are fatal or life-threatening should be reported in maximum:
3 days
5 days
7 days
15 days
9. The following scenario "A 42-year-old female patient took Naproxen and immediately got very dizzy. She went to the Emergency Department of the General Hospital for further investigations and was sent home after a few hours with the recommendation to stop taking the medication." describes a:
AE
SAE
SUSAR
Special Situation
10. Select the correct statements:
A company analysis is an analytical approach that supports signal detection process.
A company analysis is required for all Serious ICSRs.
In the interpretation of safety data, patient demographics, concurrent medical conditions and concomitant medications are not important.
The Analysis of Similar Events (AOSE) includes a search in the Global Safety Database for all Preferred Terms (PTs) related to the reported SUSAR.
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