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Posted By: srinivas Member Level: Gold Posted Date: 30 May 2008
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2008 Andhra Pradesh State Jawaharlal Nehru Technological University Biotechnology III B.Tech II Semester Regular Examinations, Apr/May 2008 REGULATORY AFFAIRS AND CLINICAL TRIALS Question paper
Code No: R05322306 Set No. 4
III B.Tech II Semester Regular Examinations, Apr/May 2008
REGULATORY AFFAIRS AND CLINICAL TRIALS
(Bio-Technology)
Time: 3 hours Max Marks: 80
Answer any FIVE Questions
All Questions carry equal marks
1. Write about the features of information security followed by the organizations. [16]
2. What are the basic criteria followed to recruit the patients for clinical trials. [16]
3. Write how the standard operating procedures monitors a particular clinical study.
[16]
4. Write about the responsibilities of the investigator as stipulated by FDA directives.
[16]
5. Explain briefly about sponsor’s audit. [16]
6. Requirements for Labeling of Investigational Medicinal Product. [16]
7. Explain the steps involved in Investigational New Drug application. [16]
8. What type of preparation you should do for inspection. [16]
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