Clinical Research Management

Clinical Research Management Q1.Write a note on various phases of clinical trials Q2.Explain patient inclusion and exclusion criteria in relation to clinical research protocol. Q3.Define randomization and explain different methods of randomization. Q4. Write a note on following documents in a clinical study- Q5.Investigator’s brochure (IB)

Q6. Case report form (CRF) Q7.Write a short note on Schedule Y of clinical research. Q8.Describe the general measures taken in an event of clinical drug toxicity. Q9.Write a short note on- Termination of Investigational New Drug Application (IND) Q10.What is clinical hold? Describe grounds for imposition of clinical hold under IND.