Rajiv Gandhi University of Health Sciences, Karnataka
V Year Pharma-D (Post Baccalaureate) Degree Examination – Sep 2012
--- Content provided by FirstRanker.com ---
CLINICAL RESEARCH
Q.P. CODE: 2874
Time: Three Hours Max. Marks: 70 Marks
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
--- Content provided by FirstRanker.com ---
LONG ESSAYS (Answer any two) 2 x 10 = 20 Marks
- Explain the ethical guidelines for clinical research
- Discuss the different Pharmacological action studies in the drug development process
- Write a note on clinical data management in clinical trials
SHORT ESSAYS (Answer any six) 6 x 5 = 30 Marks
--- Content provided by FirstRanker.com ---
- Explain CDSCO guidelines
- Explain the phase II clinical trials
- Write a note on drug characterization
- Discuss about IND application
- Role and responsibilities of auditors
- Write a note on CRA
- What are the different regulatory systems in USA, EUROPE and INDIA
- Write a note on challenges in the implementation of ICH guidelines
--- Content provided by FirstRanker.com ---
SHORT ANSWERS 10 x 2 = 20 Marks
- Informed consent
- Protocol
- Phase IV
- Composition of IEC
- Therapeutic index
- Members of ICH
- Chronic toxicity
- Cohort studies
- Safety monitoring
- Investigator
--- Content provided by FirstRanker.com ---
--- Content provided by FirstRanker.com ---
--- Content provided by FirstRanker.com ---
*****
This download link is referred from the post: RGUHS Pharma-D Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
--- Content provided by FirstRanker.com ---