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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. 2
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. What is case report form and what are the essential principles of CRF. [16]
2. Write about the role of ethics committee in the conduct of clinical trials. [16]
3. Write about retrospective of clinical Audit. [16]
4. What is GCP by ICH. Write about the guidelines mentioned in the ICH GCP?
[16]
5. Auditing of quality management system. Explain. [16]
6. Explain. Medicine Health care Research Agency-QSE. [16]
7. Write short notes on the following:
(a) Waivers
(b) Adverse drug experiences
(c) Post marketing 15-day “Alert Reports”. [6+6+4]
8. Brief the recent developments in Ethical guidelines. [16]
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