Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 2nd Semester 74946 CLINICAL RESEARCH and PHARMACOVIGILANCE Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.
Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmacology) (2017 Batch) (Sem.?2)
CLINICAL RESEARCH & PHARMACOVIGILANCE
Subject Code : MPL-204T
M.Code : 74946
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
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. 7
b. Elaborate on roles and responsibilities of contract research organization. 8
3. a. Write a note on ICH-GCP guidelines for clinical trials. 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. 15
5. Write short notes on the following :
a. Pharmacoepidemiology 5
b. Phase 0 clinical trial 5
c. Schedule Y 5
6. Discuss the following with suitable examples :
a. Case report forms 5
b. Clinical trial monitoring 6
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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This post was last modified on 07 December 2019