BOT 2020 Feb Question Papers || Bachelor of Occupational Therapy
FACULTY OF PHARMACY
Pharm D (6-YDC) V-Year (Main & Backlog) Examination, July 2018
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Subject: Clinical Research
Time: 3 Hrs Max.Marks: 70
Note: Answer all questions from Part — A. Any Five questions from Part - B.
PART - A (10x2 = 20 Marks)
- What is drug discovery? Write basic approaches to drug discovery.
- Write note on registration of clinical trials.
- Write different methods of lead identification.
- List the various functions of data management team.
- What is periodic and interim review by EC?
- What is waiver of consent in clinical research?
- What is a target molecule? Write briefly the different approaches to target identification.
- What are different control treatments in clinical trial design?
- Explain the responsibilities of monitor in clinical trials.
- What are “equivalence”, “superiority” and “non-inferiority” trials?
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PART - B (50 Marks)
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- Explain the term “lead molecule”. Describe in detail the lead identification and optimization process.
- List the various responsibilities of IRB. Explain review procedures of a research proposal by IRB.
- Explain post marketing surveillance methods.
- Explain the components of clinical trial-design.
- Discuss various animal pharmacology testing required for discovery of new drugs.
- a) Give an overview of regulatory environment in USA.
b) Write detailed note on selection of special groups as research participants. - Explain the statement of general principles and specific principles for clinical evaluation of drugs.
- a) Explain data capture in CDM.
b) Write note on ICF and PIC.
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