FACULTY OF PHARMACY
Pharm. D. (6YDC) V Year (Main) Examination, Sept/Oct 2017
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 (10x2 20 Marks)
1. Write about the responsibilities of IRB. 2
2. Define IND and write its applications. 2
3. What is the role of dosage form in drug development process? 2
4. What is the role of auditor's in clinical trials? 2
5. Write about the protocol design in clinical study document. 2
6. Write in brief about safety monitoring in clinical trials. 2
7. Write about different methods of randomization in clinical trials. 2
8. Define informed consent process and when the documents of ICP are revised. 2
9. Write about methods of reporting ADR. 2
10. Write about the advantages of double-blind design in clinical trials. 2
PART B (5x10 50 Marks)
11. Explain in detail about GCP according to ICH guidelines. 10
12.(a) Write the responsibilities of sponsor and clinical research associate in clinical
trial. 7
Write a note on CRF. 3
13. Define clinical trial and explain various phases of clinical trials. 10
14. Explain about regulatory environment in USA and India. 10
15.(a) Write about data management in clinical trials. 5
Explain how the challenges can be overcome in implementation of guidelines. 5
16. Explain in detail how a clinical trial can be designed. 10
17. Write in detail about submission of ANDA. 10
18.(a) Define ADR and explain how it can be monitored. 5
Write the composition and responsibilities of IEC. 5