Draw the flow chart of drug development process. Discuss the advantages and limitations of micro-dosing clinical trial.
[6 marks]Discuss the roles and responsibilities of sponsors in clinical research.
[4 marks]Define IND application and write contents of IND application.
[4 marks]Define Bias. Discuss in detail about various sources of bias and methods to avoid Bias.
[6 marks]What is Randomization? Brief about static and adaptive designs.
[4 marks]Give an account on Abbreviated New drug Application.
[4 marks]Discuss various methods of post marketing surveillance study.
[6 marks]Describe the various pharmacological approaches to drug discovery.
[4 marks]Compare and contrast of Phase-Iand Phase-II clinical trial.
[4 marks]Give a note on constitution and responsibilities of institutional review board.
[6 marks]Write a short note on regulatory setup in Europe.
[4 marks]Discuss the challenges in implementation of guidelines in clinical trials.
[4 marks]Explain the components of clinical research protocol and the process of protocol preparation.
[6 marks]Write the safety issues on the investigational new drugs.
[4 marks]Discuss in detail about the role and responsibilities of clinical research associate in clinical research. Q. 6 (a) Describe the clinical trial data management process and its benefits.
[6 marks]Briefly write about study site audits and its significance.
[4 marks]Write a brief note on case record form.
[4 marks]Describe in detail about regulatory setup that governs the clinical research process in India.
[6 marks]Write a short note on informed consent process.
[4 marks]Discuss Good Clinical Practice and its principles.
[4 marks]