Explain in detail the process and importance of designing the study protocol in clinical trial
[6 marks]Enlist various phases of Clinical trial. Mention objective of each phase.
[4 marks]Illustrate schematic representation of integrated drug development process
[4 marks]What is IND? Enlist different criteria for IND.
[6 marks]Define Ethics. Discuss ethical issues of clinical research involving children.
[4 marks]Explain Belmont Report and Nuremberg trial
[4 marks]Explain designing of CRF with suitable example
[6 marks]Explain the challenges in implementation of guidelines in clinical trials
[4 marks]What is significance of Post marketing surveillance? Explain
[4 marks]Write a note on CDSCO guidelines for clinical research
[6 marks]What is ANDA? Explain review process of ANDA
[4 marks]Explain the roles of DSMB
[4 marks]Describe composition and responsibilities of IEC
[6 marks]Enlist principles of ICH GCP guidelines
[4 marks]Write roles and responsibilities of Clinical Research Associate in clinical trial Q. 6 (a) Describe pharmaceutical regulations with regard to clinical trials in European union
[6 marks]Explain roles and responsibilities of Investigator
[4 marks]Explain Informed Consent Process in detail
[4 marks]Give an overview of regulatory environment for clinical trial in USA
[6 marks]Describe the procedure of communicating Periodic Safety Update Reports (PSUR).
[4 marks]Explain components of data management in clinical trial
[4 marks]