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Roll No.
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Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmacology) (2017 Batch) (Sem.-2)
CLINICAL RESEARCH & PHARMACOVIGILANCE
Subject Code : MPL-204T
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M.Code: 74946
Time: 3 Hrs.
Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
- Attempt any FIVE questions out of SIX questions.
- Each question carries FIFTEEN marks.
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Write an extensive note on adverse drug reactions with suitable examples and/or flow charts.
15
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a. Discuss history, scope and significance of pharmacovigilance.
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7
b. Elaborate on roles and responsibilities of contract research organization.
8
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a. Write a note on ICH-GCP guidelines for clinical trials.
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9
b. Discuss the concept of informed consent in clinical trial with suitable examples.
6
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Give a detailed account on various components of clinical trials.
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15
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Write short notes on the following :
a. Pharmacoepidemiology
5
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b. Phase 0 clinical trial
5
c. Schedule Y
5
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Discuss the following with suitable examples :
a. Case report forms
5
b. Clinical trial monitoring
6
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c. Sterile and aseptic area layout
4
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NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.
1| M-74946
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(S31)-1749
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