Discuss the roles & responsibilities of Investigator & Clinical research associate as per ICH – GCP
[6 marks]Write a note on various phases of Clinical trials
[4 marks]What is significance of Post marketing surveillance? Explain
[4 marks]Discuss ICH – GCP guidelines of clinical trials
[6 marks]Write a note on ADME profiling
[4 marks]Explain the process of designing study protocol in clinical trial
[4 marks]Explain the roles of DSMB
[6 marks]Discuss various drug characterization techniques in Drug development process
[4 marks]What is ANDA? Explain review process of ANDA
[4 marks]Describe pharmaceutical regulations with regard to clinical trials in European union
[6 marks]Explain double blind & randomization method
[4 marks]Discuss composition and responsibilities of IEC
[4 marks]Write a note on CDSCO guidelines for clinical research
[6 marks]Define Ethics. Discuss ethical issues of clinical research involving children.
[4 marks]Explain Informed Consent Process Q. 6 (a) Explain designing of CRF with suitable example
[6 marks]Discuss the challenges in the implementation of guidelines
[4 marks]Give an overview of regulatory environment in USA
[4 marks]Describe the procedure of communicating ADR reports & Periodic Safety Update Reports (PSUR).
[6 marks]Write a note on roles & responsibilities of sponsor in clinical trial
[4 marks]What is Informed Consent Form? Which information must be given to each potential research subject before enrolling in clinical trial?
[4 marks]