Clinical Research Management - Write a short note on Termination of Investigational New Drug Application _IND_ What is clinical hold Describe grounds for imposition of clinical hold under IND

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                              Clinical Research Management

1. Write a note on various phases of clinical trials

2.  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.