Download RGUHS M.Pharm 1st Year 2020 5140 Clinical Research Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 1st Year (First Semester) 2020 5140 Clinical Research Previous Question Paper

Rajiv Gandhi University of Health Sciences
First Semester M. Pharm Degree Examination - 17-Jan-2020
[Time: 3 Hours]
[Max. Marks: 75]
Clinical Research
Q.P. CODE: 5140
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Explain in detail the ANDA submission.
2.
Explain in detail the various study designs of BA/BE studies.
3.
Explain in detail the principles of ethics in conducting biomedical research and write the
challenges in implementing the ethical guidelines.
4.
Explain the different phases of clinical trial and write the requirements to conduct clinical trials
as per schedule Y.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Explain in detail the composition of IRB. Add a note on different types of review.
6.
Write a short notes on lead optimization.
7.
Write a note on CDSCO guidelines.
8.
Discuss the roles and responsibilities of sponsor in a study.
9.
Explain in detail the prospective and retrospective studies.
10. Explain the roles and responsibilities of contract research organization.
11. Write a short notes on guidelines to develop Investigator's brochure.
12. Discuss the clinical trial document preparation.
13. Define IND. Discuss the different types of IND.
14. Write a note on data mining and warehousing and write its advantages in clinical trial data
management.
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