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Pune University - Sem - IV : Clinical Research & Database Management, April 2010

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Total No. of Questions : 7] [Total No. of Pages : 1 P1432 [3727-B]- 803 M.Sc. BIOTECHNOLOGY BT - 43 : Clinical Research and Database Management (Sem. - IV) (2008 Pattern) (New) Time : 1 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) What is FDA? What are its duties, responsibilities and authority in the context of clinical research? [10] Q2) Explain with suitable example research, development and marketing of medical device. [10] Q3) Write notes on : [10] a) Drug development and biologies. b) GLP and GMP in pharmaceutical Industry. SECTION - II Q4) Explain the significance of clinical trials. Outline the design for a clinical trial. [10] Q5) State the principles of data management in the context of clinical research.[10] Q6) What are the essentials of source documentation? Add a note on maintenance and management of essential documents. [10] Q7) Write notes on : [10] a) Recording and reporting non serious adverse events. b) Designing and development of case report form. xxxx

 

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Additional Info : MSc BIOTECHNOLOGY, BT 43 : Clinical Research & Database Management (2008 Pattern) (New Course) (Semister - IV), Pune University
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