Gujarat Technological University 2010 M.Pharm Clinical Research And Regulatory Affairs - Question Paper
Seat No. Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharmacy Sem-II Examination July 2010 Subject code: 920206 Subject Name: Clinical Research And Regulatory Affairs
Date: 07 /07 /2010 Time: 11.00 am - 02.00 pm
Instructions: Total Marks: 80 1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
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Q.1 |
(a) |
Discuss in detail the roles and responsibilities of the following clinical trial personnel as per ICH GCP guidelines- (i) Investigator (ii) Sponsor |
06 |
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(b) |
Explain patient inclusion and exclusion criteria in relation to clinical research protocol. |
05 | |
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(c) |
Write a short note on- Termination of Investigational New Drug Application (IND) |
05 | |
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Q.2 |
(a) |
Describe design, conduct and outcome of Phase I and Phase II of clinical trials. |
06 |
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(b) |
Describe in brief physical and chemical characterstics of a drug substance to be included in New Drug Application (NDA). |
05 | |
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(c) |
Write a short note on- Abbreviated New Drug Applications (ANDA). |
05 | |
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Q.3 |
(a) |
Explain the phases of Drug discovery and Drug development. |
06 |
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(b) |
Define randomization and explain different methods of randomization. |
05 | |
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(c) |
Writa a note on following documents in a clinical study- (i) Investigators brochure (IB) (ii) Case report form (CRF) |
05 | |
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Q.4 |
(a) |
Discuss principles of ICH- GCP guidelines. |
06 |
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(b) |
What is clinical hold? Describe grounds for imposition of clinical hold under IND. |
05 | |
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(c) |
Write a short note on various methods of Post Marketing surveillance. |
05 | |
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Q.5 |
(a) |
Describe briefly the content and format of NDA. |
06 |
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(b) |
What in Institution Ethics Committee (IEC)? Give its composition and responsibilities. |
05 | |
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(c) |
Write a short note on Schedule Y of clinical research. |
05 | |
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Q. 6 |
(a) |
Write a short note on regulatory requirements and methodology of BA/BE studies. |
06 |
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(b) |
Explain the following terms- (i) Waivers (ii) Orphan drugs |
05 | |
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(c) |
Write a short note on- IND safety reports |
05 | |
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Q.7 |
(a) |
Discuss the principles of sampling in clinical trials. |
06 |
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(b) |
Give the importance of Informed Consent (IC) in clinical trials and explain the process of obtaining informed consent. |
05 | |
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(c) |
Write a note on ICMR guidelines for Biomedical Research on human subjects. |
05 |
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Attachment: |
| Earning: Approval pending. |
