Clinical Trials - Quiz | Take the Quiz

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:

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.