Dr. A.P.J. Abdul Kalam University M.Pharm (Pharmacology) II Sem Clinical Research and Pharmacovigilance [MPL204T] June 2021 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Pharmacology)

Second Semester Examination, June-2021

Clinical Research and Pharmacovigilance [MPL204T]

Time: 3:00 Hrs Max Marks 75

Note : Attempt any five questions. All questions carry equal marks.

Q.1 (a) Describe the Clinical Trials: Types and Design Experimental StudyRCT and Non RCT.

(b) Explain the Ethical Committee: Institutional Review Board.

Q.2 (a) Write about the Clinical Study Report Clinical Trial Monitoring & Safety

Monitoring in Clinical Trial.

(b) Discuss about evaluation of medication safety.

Q.3 (a) Describe the classification of diseases, International Nonproprietary

names for drugs.

(b) Write note on Establishing pharmacovigilance centres in Hospitals,

Industry and National programmes related to pharmacovigilance.

Q.4 (a) Discuss about the WHO international drug monitoring programme, WHO

and Regulatory terminologies of ADR.

 (b) Describe the Ethical principles governing informed consent process.

Q.5 (a) Explain the Ethical Guidelines for Biomedical Research and Human

Participant- Schedule Y.

 (b) Explain the History and progress of pharmacovigilance.

Q.6 (a) Describe the Targeted clinical investigations and Vaccine safety

surveillance.

 (b)Explain the Contract Research Organization and its management.

Q.7 (a) Write note on Spontaneous reporting system and Reporting to regulatory

authorities.

(b) Give detail Note on the Passive and Active surveillance, Comparative

observational studies

Q.8 Write short note on (Any 3)

(i) Pharmacoepidemiology

(ii) Pharmacoeconomics

(iii) Safety pharmacology

(iv) Pharmacovigilance

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