Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 January (Master of Pharmacy) 1st Year (First Year) 2nd Year 5180 Clinical Research And Pharmacovigilance II Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination - JAN-2019
[Time: 3 Hours]
[Max. Marks: 75]
Clinical Research & Pharmacovigilance -II
Q.P. CODE: 5180
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 the process of designing study protocol in clinical trials. Write the importance
of informed consent process.
2.
Give a detailed account of ICH-GCP guidelines.
3.
Explain the international classification of diseases.
4.
Describe the data reporting form, banned drug regulatory considerations in
Pharmacovigilance.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Role of regulatory authority in clinical trials.
6.
Write about Nuremberg code 1946.
7.
Write a note on Informed Consent Process.
8.
Write short note on Schedule Y.
9.
Define, types and management of ADR.
10.
Write about passive and active surveillance.
11.
Write a note on vaccine safety surveillance.
12.
Write short notes on Cohort study.
13.
Objectives of good clinical practice (GCP).
14.
Explain the history and progress of PV.
* * * * *

---

Document Outline

• ??
• ??
• ??

---