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III B.Tech II Semester Supplimentary Examinations, Aug/Sep 2008
REGULATORY AFFAIRS AND CLINICAL TRIALS
(Bio-Technology)
Time: 3 hours Max Marks: 80
Answer any FIVE Questions
All Questions carry equal marks
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3. Write how the standard operating procedures monitors a particular clinical study.
[16]
(a) IEC
(b) Essential documentation
(c) Investigator
(d) IRB. [16]
6. What are the Current and Future European requirements in clinical trials? [16]
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Code No: R05322306 Set No. 2
III B.Tech II Semester Supplimentary Examinations, Aug/Sep 2008
REGULATORY AFFAIRS AND CLINICAL TRIALS
(Bio-Technology)
Time: 3 hours Max Marks: 80
Answer any FIVE Questions
All Questions carry equal marks
⋆⋆⋆⋆⋆
1. Define clinical trials. What are the ethical principles for medical research involving
human subjects with special emphasis on declaration of Helsinki 2000 amendment?
[16]
2. How to asses the mental competence of a person to recruit for the studies. [16]
4. What are the commercial sanctions the sponsor will face in case of non-compliance
of USA directives on GCP for clinical trials in India? [16]
5. Write about the current regulatory guidelines for Investigational Product. [16]
7. Brief the content and format of an application required to submit for New Drug
Approval. [16]
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Code No: R05322306 Set No. 3
III B.Tech II Semester Supplimentary Examinations, Aug/Sep 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 codes of practice for regulation of drug preparation and marketing.
[16]
2. What are the risks involved with the investigator during a clinical trial study. [16]
3. Write about the difference in the auditing of in-house and On-site audits. [16]
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Code No: R05322306 Set No. 4
III B.Tech II Semester Supplimentary Examinations, Aug/Sep 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 in detail about Clinical trial directives made by European Union. [16]
4. What are the essential documents needed during the clinical conduct of the study.
[16]
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