FACULTY OF PHARMACY
Pharm. D. YDC) V Year (Instant) Examination, January 2018
Subject: Clinical Research
Time: 3 Hours Max. Marks: 70
Note: Answer all questions from Part A. Answer any five questions from Part B.
PART A (10 x 2 20 Marks)
1 Write briefly about different types of masking designs in clinical trials. 2
2 Define IND and explain when IND application is not required. 2
3 What are the advantages of randomized clinical trials? 2
4 Explain the importance of drug characterization in drug discovery. 2
5 Write about the role of regulatory authority in clinical trials. 2
6 Explain briefly about phase II clinical trials. 2
7 Write briefly about pharmacological approach in drug development. 2
8 What is meant by informed consent process and explain the contents in document? 2
9 Explain the procedures of IRB. 2
10 Define ADR, write briefly about the monitoring of ADR. 2
PART B x 10 50 Marks)
11 Explain in detail about CDSCO guidelines in maintaining good clinical practice. 10
12 Explain about phase III clinical trails guidelines. 5
Write about various methods of post marketing surveillance. 5
13 Explain in detail about the design of clinical trials. 10
14 Write about safety measures in ADR. 5
Explain the components of data management in clinical trials. 5
15 Write in detail about the submission of ANDA. 10
16 Explain about composition, responsibilities and procedures of IEC. 10
17 Write about regulatory authority in India. 5
Explain the responsibilities of investigators and auditors in clinical trial. 5
18 Write about methods of safety monitoring in clinical trials. 6
Write a note on ethical guidelines in clinical research. 4