Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm- SEMESTER- II EXAMINATION SUMMER 2017
Subject Code: 2920206 Date: 31/05/2017
Subject Name: Clinical Research and Regulatory Affairs
Time: 10:30 AM to 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Discuss concept of Para I to IV in ANDA.
06

Describe in brief the various principles of GCP
05

Write a short note on clinical trial protocol
05
Q.2

Classify NDA. Discuss regulatory requirements for NDA.
06

Discuss the responsibilities of investigator in a clinical trial.
05

Write a short note on informed consent process.
05
Q.3

Discuss the contents of Investigator's Brochure.
06

Write a note on composition of IRB/IEC.
05

Discuss the contents of clinical trial report.
05
Q.4

Discuss various phases of clinical trials.
06

Enlist the various essential documents required before the clinical trial is initiated and their location.
05

Write a short note on review procedure of IEC.
05
Q.5

Discuss in brief about the drug discovery process.
06

Write a note on data management in clinical research.
05

Write a note on sampling in clinical trials.
05
Q. 6

Write a short note on CRF.
06

Write a short note on quality assurance in clinical research.
05

Explain different methods for post marketing surveillance.
05
Q.7

Discuss study conduct methodology of BE study.
06

Discuss historical evolution of GCP guidelines.
05

Explain the process of obtaining approval for clinical trial as per Schedule Y in India.
05