Rajiv Gandhi University of Health Sciences
First Semester M.Pharm Degree Examination
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[Time: 3 Hours] [Max. Marks: 75]
Clinical Research
Q.P. CODE: 5140
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
- Explain briefly the various steps of Drug Development Process.
- Explain the different randomization techniques used in clinical research.
- What are the roles and responsibilities of the sponsor? Explain.
- What are the guidelines for the preparation of case report forms? Explain.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Explain briefly about the phases of clinical trials.
- What is the criteria for audit process? Explain.
- What is the difference between experimental and observational methods?
- Write briefly on “ICH - GCP guidelines”.
- Explain the process of “Informed Consent”.
- Discuss the criteria for the inclusion and exclusion of subjects in clinical trials.
- Discuss about the constitution and functions of ethical committee.
- Explain the following (a) Cohort Study (b) Case control study.
- Explain the role of data mining in clinical trial data management.
- What are the responsibilities of stake holders in audit process?
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