LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Explain in detail the various study designs of BA/BE studies.
- Explain in detail the principles of ethics in conducting biomedical research and write the challenges in implementing the ethical guidelines.
- Explain the different phases of clinical trial and write the requirements to conduct clinical trials as per schedule Y.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain in detail the composition of IRB. Add a note on different types of review.
- Write a short notes on lead optimization.
- Write a note on CDSCO guidelines.
- Discuss the roles and responsibilities of sponsor in a study.
- Explain in detail the prospective and retrospective studies.
- Explain the roles and responsibilities of contract research organization.
- Write a short notes on guidelines to develop Investigator’s brochure.
- Discuss the clinical trial document preparation.
- Define IND. Discuss the different types of IND.
- Write a note on data mining and warehousing and write its advantages in clinical trial data management.
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