Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MRA103T Date: 05/01/2019
Subject Name: Clinical Research Regulations
Time :10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt all questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Write short note on Phase IV studies.
06

Write the guidelines for clinical investigation and evaluation of medical devices.
05

Discuss historical perspectives of Clinical research.
05
Q.2

Discuss the key points of Schedule Y.
06

Write the composition, roles and responsibilities of Ethics Committee.
05

Discuss the ethical considerations involved in collecting patients consent.
05
Q.3

Write a note on CRO and its management.
06

Justify the use of placebos in clinical trials.
05

Describe briefly biostatistics applied in clinical research.
05
Q.4

Write a note on ANDA 505(j) application.
06

Discuss the contents of Patient information sheet.
05

Discuss vulnerable population in a clinical trial.
05
Q.5

Compare and contrast Indian GCP and ICH GCP guidelines.
06

Write a note on E7 guidelines.
05

Describe various study designs adopted in clinical trials.
05
Q. 6

Write a note on Good Pharmacovigilance practices.
06

Provide the details about ISO 14155.
05

What information is provided in EU Annual Safety Report?
05
Q.7

Discuss Bioavailability and Bioequivalence requirements according to CFR 21Part 320.
06

What are the responsibilities of sponsor and investigator in ethical conduct of clinical research?
05

What are the regulatory requirements to market a pharmaceutical product in European countries?
05