Download Pharm D 5th Year 2011 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2011 Oct 383825 Clinical Research Previous Question Paper

[KZ 825] OCTOBER 2011 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE)
DEGREE EXAMINATION
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH
Q.P. Code: 383825
Time: Three Hours Maximum: 100 marks
Answer ALL questions in the same order.
I. Elaborate on : Pages Time Marks
(Max.) (Max.) (Max.)
1. a) Define investigational new drug application and
describes the component and categories of investigational
new drug application. 17 40 min. 20
b) What are the essential documents for the conducting of
clinical trials and its purpose?
2. a) Roles and responsibilities of auditors in clinical research
b) Define serious adverse event in clinical trial and 17 40 min. 20
responsibilities of investigators in reporting
II. Write notes on :
1. Various phases of clinical trial. 4 10 min. 6
2. Informed consent process. 4 10 min. 6
3. Central drug standard control organisation and food and
drug administration. 4 10 min. 6
4. Investigators brochure. 4 10 min. 6
5. Randomization. 4 10 min. 6
6. Source documents in clinical trial. 4 10 min. 6
7. Vulnerable subjects. 4 10 min. 6
8. Roles and responsibilities of regulatory authority in relation to
clinical trial. 4 10 min. 6
9. What are the responsibilities of clinical data manager? 4 10 min. 6
10. Define the followings:
(i) Blinding (ii) Comparator (iii) Good clinical practice. 4 10 min. 6

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