ARAVIND - 09901366442 – 09902787224
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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.
aravind.banakar@gmail.com
ARAVIND - 09901366442 –
09902787224
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