Questions and Answers

 1. 

Document mandatory to enroll subject in clinical research study?

o A. 

Protocol

o B. 

Case Report Form

o C. 

Informed Consent Form

o D. 

Investigators Brochure

 2. 

Preclinical Studies are conducted on animals and artificial cells in labs?

o A. 

True

o B. 

False

 3. 

In how many phase clinical research study is conducted?

o A. 

o B. 

o C. 

8
 o D. 

 4. 

To begin clinical research study it is mandatory to get approval from?

o A. 

Sponsor

o B. 

Regulator

o C. 

Regulators and ethics committee both

 5. 

Tuskegee syphilis study was done from 1932 till1972.

o A. 

True

o B. 

False

 6. 

As a result of thalidomide tragedy neonatal death happened.

o A. 

True

o B. 

False

 7. 

.........................finances the study.

 8. 
 Conflict of interest is a risk factor for scientific misconduct in clinical research
studies.

o A. 

True

o B. 

False

 9. 

Whose responsibility is to prepare essential documents like protocol/

investigators brochure/ informed consent form/ case report form in clinical
trials?

o A. 

Investigator

o B. 

Ethics committee

o C. 

Scientist

o D. 

Sponsor

 10. 

Adverse Drug Reaction reporting is mandatory in clinical trials.

o A. 

True

o B. 

False