HyderabadOU coe OU coe
Code No. 1216/PCI
FACULTY OF PHARMACY
M. Pharmacy (Pharmacology) II-Semester (Main) Examination,
August 2018
Subject: Clinical Research and Pharmacovigilance
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1. Define investigator brochure. Discuss about the contents of IB in clinical trial.
2. Explain the principles of ICH-GCP guidelines.
What are the roles and responsibilities of sponsor and contract research
organization in clinical trial?
3. Explain in detail about RCT and NRCT.
4. Write in detail about ethical principles governing informed consent process.
Write about Schedule Y in clinical trials.
5. Write about safety monitoring in clinical trial.
6. Give an overview of the regulatory environment in National and International
aspects.
7. Write about predictability and preventability assessment methods of ADR.
8. Write about
Vigiflow
Aris G of pharmacovigilance.