KSBM – Clinical Research Management – Write a short note on- Termination of Investigational New Drug Application (IND)-Write a short note on Schedule Y of clinical research

Write a short note on- Termination

 Clinical Research Management

Questions:

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-

(i) Investigator’s brochure (IB)

(ii) Case report form (CRF)

Q5. Write a short note on Schedule Y of clinical research.

Q6. Describe the general measures taken in an event of clinical drug toxicity.

Q7. Write a short note on- Termination of Investigational New Drug Application (IND)

Q8. What is clinical hold? Describe grounds for imposition of clinical hold under IND.

 

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