Assignment 7: Experimental study

designs: Clinical trials

Assignment not submitted

1) Which of the following constitutes the corner stone of the design of randomized 1 point
controlled trials?

a) Recruitment

b) Randomization

c) Blinding

d) Placebo

2) Which of the following denotes a pharmacologically inactive agent that investigators 1 point
administer to participants in the control group of a trial?

a) Comparator drug

b) Placebo

c) Conjugate

d) Drug under investigation

3) All of the following are key methodological components of a Randomized Controlled 1 point
Trials are EXCEPT

a) Use of a control to which the experimental intervention is compared

b) Random assignment of participants to intervention groups

c) Taking informed consent from all study participants

d) Intervention is provided to all the study participants 

4) Which of the following denotes the purpose of a double-blinding in a clinical trial? 1 point

a) Achieve comparability of all arms of a clinical trial 

b) Avoid observer and participant bias

c) Avoid observer bias and sampling variation

d) Avoid subject bias and sampling variation

5) Which phase of a clinical trial is referred to post-marketing surveillance? 1 point

a) Phase 1

b) Phase 2

c) Phase 3

d) Phase 4

6) Which of the following can reduce the chance of co-intervention in a clinical trial? 1 point

a) Random sampling

b) Allocation concealment

c) Informed consent

d) Blinding

7) State whether TRUE or FALSE. In a randomized controlled trial, allocation concealment 1 point
is when the investigator is unaware of the intervention of the participants to one of the study arms
before and until the assignment is complete. 

a) True

b) False

8) A phase-I vaccine trial is conducted among which of the following groups of 1 point
participants?

a) Healthy volunteers

b) High risk group

c) Diseased population

d) Laboratory animals

9) In a clinical trial of an investigational new drug, the participants were blinded to their 1 point
treatment allocation. However, the investigators and data analysts were aware about the treatment
allocation. Therefore, this randomized controlled trial would be considered as __________.

a) Double blinded

b) Triple blinded 

c) Single blinded

d) Open clinical trial

10) In a randomized controlled trial, overly restrictive exclusion criteria may result in which 1 point
of the following?

a) Decreased external validity

b) Decreased internal validity

c) Problems with recruitment

d) Both 'a' and 'c'