Write a note on Various phases of clinical trial.
[6 marks]Give a brief note on investigator’s brochure.
[4 marks]What is Data Safety Monitoring Board (DSMB)?
[4 marks]Write in detail about Data storage and security in CDM.
[6 marks]Explain the regulatory environment for conduct of clinical trials in USA.
[4 marks]Write a note on ICH guidelines in clinical trials.
[4 marks]Discuss in detail about CDSCO guidelines.
[6 marks]What is the role of ICMR in regulation of clinical trials?
[4 marks]Write a note on Informed consent process.
[4 marks]What is NDA? Mention the data which is submitted with the application and its review process.
[6 marks]Write Significance of post marketing surveillance.
[4 marks]Write Roles and responsibilities of Investigations.
[4 marks]What is regulatory authority? Write the general roles and responsibilities of regulatory authority.
[6 marks]Describe the procedure of communicating ADR reports & Periodic Safety Update Reports (PSUR).
[4 marks]What is drug discovery? What are the steps involved in the process? Q. 6 (a) Write in detail various components of clinical trial “protocol”. Add notes on protocol amendments.
[6 marks]Discuss various animal pharmacology testing required for discovery of new drugs.
[4 marks]Elaborate the role and responsibilities of sponsor in clinical trials as per ICH GCP.
[4 marks]Explain the IEC review procedure of a research proposal and the methods of review process adopted by IEC.
[6 marks]Give an overview of regulatory environment in Europe.
[4 marks]Explain the importance of dosage form design in pre-clinical and clinical stages.
[4 marks]