With schematic representation, discuss drug development process.
[6 marks]Write a note on informed consent process.
[4 marks]Discuss the responsibilities of clinical data manager.
[4 marks]Discuss various phases of clinical trials.
[6 marks]Write a note on ANDA submission.
[4 marks]Describeprotocol amendment in clinical research.
[4 marks]Explain the components of ICH-GCP.
[6 marks]Explain ethical guidelines in clinical research.
[4 marks]List the type of audits and its importance in clinical trials.
[4 marks]Discuss the composition and responsibilities of IRB/IEC.
[6 marks]Write a note on electronic data capturing system and its role in clinical research.
[4 marks]Describe the methods and benefits of post marketing trials.
[4 marks]Define serious adverse event in clinical trials and the role of investigators in reporting them.
[6 marks]Enlist the clinical study documents. Explain its importance.
[4 marks]Discuss randomization in clinical trials. Q. 6 (a) Write a note on overview of regulatory environment in India.
[6 marks]Discuss data migration and archiving.
[4 marks]Define the following terms:
[4 marks]Vulnerable subjects b) Comparator c) Blinding d) Good clinical practices.
[ marks]Define investigator’s brochure and describe its components.
[6 marks]Write a note on schedule Y.
[4 marks]Explain the following terms:
[4 marks]Impartial witness b)PSUR c)Placebo d) Candidate drug.
[ marks]