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Rajiv Gandhi University of Health Sciences, Karnataka
V Year Pharm-D / II Year Pharm-D (Post Baccalaureate) Degree Examination – NOVEMBER 2015
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Time: Three Hours
Max. Marks: 70 Marks
CLINICAL RESEARCH
Q.P. CODE: 2874
Your answers should be specific to the questions asked
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Draw neat labeled diagrams wherever necessary
LONG ESSAYS (Answer any two) 2 x 10 = 20 Marks
- Explain in detail the pharmacological and toxicological approaches to the drug discovery.
- Explain in detail the various phases of clinical trials.
- Describe the role and responsibilities of sponsor and investigator as per ICH-GCP guidelines.
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SHORT ESSAYS (Answer any six) 6 x 5 = 30 Marks
- Describe the drug characterization in drug discovery.
- Explain the safety monitoring in clinical trial.
- Write a note on ANDA submission.
- Write a note on IND application.
- What are the elements of informed consent process?
- Explain various regulatory systems in USA and India.
- Write a note on challenges in implementation of ICH guidelines.
- Designing of CRF.
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SHORT ANSWERS 10 x 2 = 20 Marks
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- Phase 0
- Preclinical studies.
- Therapeutic index.
- Quality assurance and quality control.
- Subject identification code.
- Members of ICH.
- Clinical trial protocol.
- Define ADR and ADE.
- Explain confidentiality.
- Composition of IEC.
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