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General Data Protection Regulation MCQs Quiz with Answers

1. Regulatory body which regulates pharmaceutical industry in India is?

a. CDSCO
b. FDA
c. ORA
d. NCTR

2. Which unit of FDA ensures the safety and efficacy of drug?

a. Center for Drug Evaluation and Research (CDER)
b. Clinical Data Network for Research (CDNR)
c. Office or Regulatory Affairs (ORA)
d. National Center for Toxicological Research (NCTR)

3. E-Signature is legally binding.

a. True
b. False

4. If we implement all the controls mentioned in Part 11 for any open or closed system, we can say that the system is Part 11 compliant?

a. True
b. False

5. What does IRB stand for?

a. Investigational Review Board
b. International Review Board
c. Institutional Review Board
d. None of these

6. ‘R’ stands for _________ in RACI matrix.

a. Requirement
b. Responsible
c. Regulation
d. None of the above

7. What does FMECA stand for:

a. Failure Mode Effects Analysis
b. Failure Mode Effects and Criticality Analysis
c. Failure Mode Effects and Critical Analysis
d. Failure Mode Effects and Control Analysis

8. Content change in validation deliverable can happen only

a. At specified time periods.
b. If it is important to change – (not sure)
c. only if changed by investigator
d. After seeking an approval

9. The acronym, GxP is sometime prefixed by a C(CGxP), which stands for:

a. Current
b. Compliance
c. Code
d. Customer

10. A systematic process of organizing information to support a risk decision to be made within a risk management process is?

a. Risk Assessment
b. Risk Analysis
c. Risk Reduction
d. Risk Management

11. An Agile approach is?

a. Process over people
b. People over process
c. Plan over process
d. Plan over people

12. Under which condition, Computer System Validation is performed?

a. If system is supporting product or process related to Patient Safety.
b. If system is supporting product or process related to Data Integrity and Quality
c. Both the above
d. None of the above

13. Which parties does the General Data Protection Regulation (GDPR) concern?

a. The companies that do not market goods and services to EU residents.
b. The major tech companies not storing personal information about citizens in Europe.
c. The data subject, the controller and the processor.
d. All the above

14. DPO stands for:

a. Data Protection Officer
b. Data Protective Office
c. Data Preventive Office
d. None of these

15. Reduce GxP also known as:

a. Predicate Rules
b. Assert Rules
c. Both the options
d. None of these

16. While transferring data from one database to another database only:

a. Format Change is allow
b. Content Change is allow
c. Both are allowed
d. None

17. Which is not classified as sensitive data by GDPR?

a. Racial or ethnic origin
b. Political opinions
c. Religious or philosophical beliefs
d. Birthday

18. Phases of SDLC are 1-Requirement gathering and Analysis, 2-Design, 3-Implentation or coding, 4-Testing, 5-Deployment, 6-Maintenance.

a. True
b. False

19. CRF stands for:

a. Case Report Form

20. If we implement all the controls mentioned in part 11 for any open or close system, We can say:

a. It’s 21 CFR part 11 Compliant

21. Title 21 of the CFR is reserved for Rule of the Food and Drug Administration

a. True
b. False

22. CFR stands for:

a. Code of Federal Regulations

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