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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. 1
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. Explain the Impartance of EU clinical Directive. [16]
2. How to asses the mental competence of a person to recruit for the studies. [16]
3. Write the roles and responsibilities of internal and external auditors. [16]
4. Write briefly about GCP guidelines followed in India and discuss how the directives
will affect clinical research. [16]
5. How “in company” audits are done. [16]
6. Explain Case Report Form used in clinical research. [16]
7. Steps used in subject treatment and submissions for use of investigational new drug.
[16]
8. Write about UK ethics approval system. [16]
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