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Health Sciences
First Semester M.H.A Degree Examination
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Time: Three Hours Max. Marks: 75 Marks
Clinical Research Regulations
Q.P. CODE: 5124
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Write in detail about different phases of clinical trials.
- Enumerate in detail about historical perspectives of clinical research.
- Describe the applicable regulations to conduct of clinical studies in USA.
- Explain the ethical requirements for conduct of clinical research as per ICH GCP E6 guidelines.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note in informed consent process.
- Write a note on role of placebo in clinical trials.
- Write a note on data safety monitoring boards.
- Discuss about financial disclosure by clinical investigators.
- Write a note on ethics of clinical research in special population.
- Write a note on CDSCO guidelines for clinical research.
- Write a note on Investigational device exemptions.
- Short note on Indian GCP guidelines.
- Write about ICMR ethical guidelines for biomedical research.
- Write briefly about schedule Y regulations in India.
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