M.Sc-M.Sc BioTechnology 4th Sem BT-43 : Clinical Research and Data Base Management(University of Pune, Pune-2013)
M.Sc. (Semester - IV) BIOTECHNOLOGY
BT-43 : Clinical Research and Data Base Management
(2008 Pattern)
Time : 1½ Hours] [Max. Marks :40
Instructions to the candidates :
1) Attempt a total of four questions selecting atleast Two Questions from each
section.
2) Answers to the sections must be written on separate answer books. 3) Neat diagrams must be drawn wherever necessary. 4) Figures to the right indicate full marks.
SECTION - I
Q1) Explain organisation, responsibilities and authority of FDA. [10]
Q2) Mention at least three medical devices. Explain R and D activities with reference
to any one device.
Q3) Write notes on any two of the following :
a) Importance of GMPs in large scale pharmaceutical production.
b) Marketing the herbal drugs.
c) Research and development of Biologics.
SECTION - I
Q4) What is a database? Mention important fields of information of a database for
clinical research. Add a note on management of clinical database. [10]
Q5) Explain the steps involved in designing the clinical trials. Add a note on
importance of clinical trials.
Q6) Write notes on any two of the following :
a) Query resolution.
b) Protection of safety of human subjects.
c) GLPs for manufacture of pharmaceuticals.
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| Earning: Approval pending. |
