Download PTU M-Pharma 2019 May 2nd Semester 74946 CLINICAL RESEARCH and PHARMACOVIGILANCE Question Paper

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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 :

1. Attempt any FIVE questions out of SIX questions.

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2. Each question carries FIFTEEN marks.

1. Write an extensive note on adverse drug reactions with suitable examples and/or flow charts.

   15

2. a. Discuss history, scope and significance of pharmacovigilance.

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   7

   b. Elaborate on roles and responsibilities of contract research organization.

   8

3. 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

4. Give a detailed account on various components of clinical trials.

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   15

5. 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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6. 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

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.

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