Write a note on various phases of clinical trials Explain patient inclusion and exclusion criteria in relation to clinical research protocol

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Clinical Research Mgmt



Write a note on various phases of clinical trials Explain patient inclusion and exclusion criteria in relation to clinical research protocol

3.  Define randomization and explain different methods of randomization.

4.  Write a note on following documents in a clinical study-

(i)  Investigator’s brochure (IB)

(ii) Case report form (CRF)

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

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

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

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



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