Clinical Trial MIC2020 Quiz

In this trial design, after patient randomization, two separate treatment arms, A and B, are given so that one group receives only treatment arm A while another group receives only treatment arm B.

• Parallel design

• Adaptive design

• Cross-over study design

• Single arm design

• 2 x 2 factorial design

Which among the following describes a minor's affirmative agreement to participate in a clinical research?

• An assent

• An dissent

In this phase of clinical trial, the side effects caused over time by a new treatment were investigated, after it has been approved and is on the market.

• Phase 4

• Phase 2

• Phase 1

• Phase 3

• Phase 0

In this document, three principles were discussed and they were (1) Respect for Persons, (2) Beneficence, and (3) Justice.

• The Malaysian Good Clinical Practice Guideline

• The Nuremberg Code

• The Declaration of Helsinki

• CIOMS Guideline

• The Belmont Report

In ICH-GCP, what is IRB/IEC.

• International Review Board/ Independent Ethics Committee

• Independent Review Board/ Institutional Ethics Committee

• Independent Review Board/ Individual Ethics Committee

• Institutional Review Board/ International Ethics Committee

• Institutional Review Board/ Independent Ethics Committee

There are some groups who have been identified by the ICH GCP as “vulnerable subjects”. Which of the following are considered vulnerable in clinical trial settings.

I. Pregnant women

II. Minors

III. Prisoners

IV. Immigrants

V. A 78-year-old dementia male patient

• I only

• I and II

• I, II, and V

• I, II, III, and IV

• I, II, III, IV, and V