Question

In case of a randomized study - two or more investigational products (medicines) are being used - an investigator keeps on randomizing the same patient until this patient gets the investigational product or medication he/she wants the patient to get to ensure the patient's health. Is this ethical conduct in view of what you learned in this course?

Select one:

a. No

b. Yes

Question 2

A data manager detects an inconsistency in trial data. He/she immediately calls the investigator of the trial at the trial site and asks for clarifications and starts the conversation by saying fraud has been committed. The data manager then sets up an appointment to visit the site and to check all data. Based upon what you learned in this course, did the data manager act as he/she should?

Select one:

a. No

b. Yes

Question 3

According to the Declaration of Helsinki, where a proven intervention does NOT exist, the physician (Select the correct answer)

Select one:

a. May consider an unproven intervention

b. May never consider an unproven intervention

c. Must always consider an unproven intervention

d. Must find a proven intervention

Answer 1

Question 1:

Answer: No

Rational:

Here investigator going on changing the medicine without patient consent, so its not considered under ethical principles. So option a is correct.

Question 2

Correct answer: option b

Rational

Whenever the trial investigation has inconsistency in data, immediately checking by manager is denoting the exact role of manager. So option b is correct.

Question 3

Correct answer: option b

Rational

Always as a researcher never consider the unproven intervention.. So option is correct, other options are incorrect.