FirstRanker's choice
Rajiv Gandhi University of Health Sciences, Karnataka
--- Content provided by FirstRanker.com ---
V Year Pharm-D (II Year Pharm D Post Baccalaureate) / V Year Pharm-D Degree Examination – NOV 2017
Time: Three Hours
Max. Marks: 70 Marks
CLINICAL RESEARCH
Q.P. CODE: 2874 / 2890
--- Content provided by FirstRanker.com ---
Your answers should be specific to the questions asked
Draw neat, labeled diagrams wherever necessary
LONG ESSAYS (Answer any two) 2 x 10 = 20 Marks
- Explain briefly about Abbreviated New Drug Application (ANDA) submission.
- Explain spontaneous reporting of ADR with suitable examples. What are the merits and demerits of spontaneous reporting?
- Discuss the principles of ICH-GCP guidelines.
--- Content provided by FirstRanker.com ---
SHORT ESSAYS (Answer any six) 6 x 5 = 30 Marks
- Enumerate designing of case report form (CRF) with a suitable example.
- Discuss electronic data processing.
- Explain the role of Business Process Outsourcing (BPOs) in conducting clinical research in India.
- Explain the objectives of various phases of clinical trial.
- Discuss in detail about CDSCO guidelines.
- Explain the role of clinical trial personnel in premature termination or suspension of a study.
- Discuss conflict of interest in clinical trials.
- Write a note on Fast track and Priority review.
--- Content provided by FirstRanker.com ---
--- Content provided by FirstRanker.com ---
SHORT ANSWERS 10 x 2 = 20 Marks
- What are LD50 and ED50?
- Name the critical pharmacokinetic parameter in drug development
- Define double blinded method.
- Role of Uppsala monitoring centre (UMC) in safety monitoring.
- Components of documentation form.
- Explain Waiver of consent.
- Note on 21CFR Part 312.
- Write a note on cohort studies.
- Responsibilities of contract research organization
- Use of placebo in clinical trials
--- 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