CR-MCQ

Q.1) IND is involved in:

a) Clinical phase 1

b) Clinical phase 2

c) Pre-clinical studies

d) Post-marketing surveillance

Ans: c)

Exp: IND is involved in pre-clinical studies

Q.2) Phase 3 in clinical trail is:

a) Therapeutic Exploratory Trial

b) Therapeutic Confirmatory Trial

c) Clinical pharmacology

d) Post-marketing Surveillance

Ans: b)

Exp: Therapeutic Confirmatory Trial

Q.3) Stakeholder in Clinical research:

a) Regulatory body

b) Study protocol writer

c) Group of participants in the study

d) Clinical project manager

Ans: a)

Exp: Regulatory body

Q.4) What is a clinical trail ?

a) Tool for testing devices

b) Tool for testing techniques of post marketed drugs

c) Tool for testing drug and medical devices and its techniques.

Ans: c)

Exp: Tool for testing drug and medical devices and its techniques

Q.5) Protocol is a:

a) Document of AE form

b) Document of SAE form

c) Document of clinical trail data

d) Document of vigilance data

Ans: c) Exp: Document of clinical trail data

Q.6) Schedule Y act is:

a) Narcotic Drugs and Psychotropic Substances act

b) Drug development act

c) Regulatory act

d) Drugs and cosmetics act

Ans: d)

Exp: Drugs and cosmetics act

Q.7) Stakeholder in Clinical research:

a) Regulatory body

b) Study protocol writer

c) Group of participants in the study

d) Clinical project manager

Ans: a)

Exp: Regulatory body

Q.8) What is SOP:

a) Standard operating procedure

b) Standard organisation procedure

Ans: a)

Exp: Standard operating procedure

Q.9) Informed consent:

a) Checklist for study Subject’s informed consent documents

b) Checklist for study conduct for investigators

Ans: a)

Exp: Checklist for study Subject’s informed consent documents

Q.10) GCP is :

a) Good conduct practice

b) Good control practice

c) Good clinical period

d) Good clinical practice

Ans: d)

Exp: Good clinical practice

Q.11) Single blinding:

a) All patients know the treatment

b) Patient does not know the treatment

c) Patient, physician and statistician/monitors do not know treatment

Ans: b)

Exp: Patient does not know treatment

Q.12) INDA:

a) Investigational new drug application

b) Investigational new drug approval

Ans: a)

Exp: Investigational new drug approval

Q.13) Thalidomide tragedy:

a) 1957- 1961

b) 1940-1961

Ans: a)

Exp: 1957- 1961

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