Quiz

1. Regulatory body which regulates pharmaceutical industry in India is? a. CDSCOb. FDAc. ORAd. 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. Trueb. 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. Trueb. False 5. What does IRB stand for? a. Investigational Review Boardb. International Review Boardc. Institutional Review Boardd. None of these 6. 'R' stands for _________ in RACI matrix. a. Requirementb. Responsiblec. Regulationd. None of the above 7. What does FMECA stand for: a. Failure Mode Effects Analysisb. Failure Mode Effects and Criticality Analysisc. Failure Mode Effects and Critical Analysisd. 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 investigatord. After seeking an approval 9. The acronym, GxP is sometime prefixed by a C(CGxP), which stands for: a. Currentb. Compliancec. Coded. Customer 10. A systematic process of organizing information to support a risk decision to be made within a risk management process is? a. Risk Assessmentb. Risk Analysisc. Risk Reductiond. Risk Management 11. An Agile approach is? a. Process over peopleb. People over processc. Plan over processd. 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 Qualityc. Both the aboved. 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 Officerb. Data Protective Officec. Data Preventive Officed. None of these 15. Reduce GxP also known as: a. Predicate Rulesb. Assert Rulesc. Both the optionsd. None of these 16. While transferring data from one database to another database only: a. Format Change is allowb. Content Change is allowc. Both are allowedd. None 17. Which is not classified as sensitive data by GDPR? a. Racial or ethnic originb. Political opinionsc. Religious or philosophical beliefsd. Birthday 18. Phases of SDLC are 1-Requirement gathering and Analysis, 2-Design, 3-Implentation or coding, 4-Testing, 5-Deployment, 6-Maintenance. a. Trueb. 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. Trueb. False 22. CFR stands for: a. Code of Federal Regulations

Quiz

General Data Protection Regulation MCQs Quiz with Answers