FACULTY OF PHARMACY
Pharm D V-Year (Main Backlog) Examination, July 2018
Subject: Clinical Research
Time: 3 Hours Max.Marks: 70
Note: Answer all questions from Part A. Any Five questions from Part B.
PART A (10x2 20 Marks)
1 What is drug discovery? Write basic approaches to drug discovery.
2 Write note on registration of clinical trials.
3 Write different methods of lead identification.
4 List out various functions of data management team.
5 What is periodic and interim review by EC?
6 What is waiver of consent in clinical research?
7 What is a target molecule? Write briefly the different approaches to target
identification.
8 What are different control treatments in clinical trial design?
9 Explain the responsibilities of monitor in clinical trials.
10 What are "equivalence", "superiority" and "non-inferiority" trials?
PART B (50 Marks)
11 Explain the term "lead molecule". Describe in detail the lead identification and
optimization process.
12 List out various responsibilities of IRB. Explain review procedures of a research
proposal by IRB.
13 Explain post marketing surveillance methods.
14 Explain the components of clinical trial design.
15 Discuss various animal pharmacology testing required for discovery of new drugs.
16 Give an overview of regulatory environment in USA.
Write detailed note on selection of special groups as research participants.
17 Explain the statement of general principles and specific principles for clinical
evaluation of drugs.
18 Explain data capture in CDM.
Write note on ICF and PIC.