Code No: R05322306 Set No.

1
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. Explain the Impartance of EU clinical Directive. [16]

2. Write about Nuremberg code. [16]

3. Write how the standard operating procedures monitors a particular clinical study.
[16]

4. Short notes on:

(a) IEC
(b) Essential documentation
(c) Investigator
(d) IRB. [16]

5. During sponsors audit what are the documents inspected. [16]

6. What are the Current and Future European requirements in clinical trials? [16]

7. What are the requirements for gaining approval by FDA? [16]

8. Write about UK ethics approval system. [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]

3. Write a short answers:

(a) Clinical Audit

(b) Monitering of clinical trial
(c) Inspection of clinical trail
(d) Audit conduct
(e) Audit certificate [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]

6. Mention the regulatory affairs for studies on human subjects. [16]

7. Brief the content and format of an application required to submit for New Drug
Approval. [16]

8. Write short notes on the following

(a) Electronic records

(b) electronic signatures. [8+8]

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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]

4. Write about the salient features of ICH GCP. [16]

5. (a) What is clinical audit and explain various types of audits.

(b) Explain how an invertigator should prepare for audits.
(c) Explain the purpose of Audits. [8+4+4]

6. Explain the method of QSE documentation. [16]

7. Brief the Post marketing reporting of adverse drug experience. [16]

8. Write about UK ethics approval system. [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]

2. Write short notes on:

(a) Negleigence in clinical trails

(b) Informed consent
(c) Mental competence. [16]

3. Write the roles of GCP auditor in Quality assurance unit. [16]

4. What are the essential documents needed during the clinical conduct of the study.
[16]

5. (a) What is clinical audit and explain various types of audits.

(b) Explain how an invertigator should prepare for audits.
(c) Explain the purpose of Audits. [8+4+4]

6. Explain. Medicine Health care Research Agency-QSE. [16]

7. What are the requirements for gaining approval by FDA? [16]

8. Write short notes on

(a) ICH principles

(b) Inspection policy. [8+8]

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