Download Pharm D 5th Year 2015 April 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2015 April 383825 Clinical Research Previous Question Paper

[LG 825] APRIL 2015 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE)
DEGREE EXAMINATION
(2009-2010 Regulation)
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH
Q.P. Code: 383825
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (4 x 10 = 40)
1. Briefly write on:
a) Double blind clinical trials.
b) Open label clinical trials.
c) Retrospective studies.
2. What is mean by informed consent?
Explain content and method of administration of informed consent as per regulatory
authorities in clinical trials.
3. What are dosage forms? Give example. Explain different type of dosage forms.
4. Explain the protocols and method of reporting ADR under Pharmacovigilance.
II. Write notes on: (6 x 5 = 30)
1. How SOPs are prepared to meet the GLP standards?
2. Write the ethical consideration in the conduct of clinical trials.
3. Write a note on safety monitoring in clinical trials.
4. What are the major challenges observed in implementation of the regulatory guidelines
in clinical trials?
5. Briefly write the data management in clinical trials.
6. Explain:
a) Placebo.
b) Human Subjects.
c) Candidate drug.
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