Question 1:

Mention the types of IRBs. If the IRB disapproves clinical study, can the sponsor approach another IRB? Justify your answer.

• Mention different types of IRBs
• Explain what options sponsor have, when an IRB disapproves a clinical study

Question 2:

What is ‘breach of contract' and add a small note on how contracts are enforced?

• Definition of ‘breach of contract'
• Brief explanation on ‘breach of contract'
• Explanation on, how contracts are enforced with an a example

Question 3:

Explain the guidelines for ethical conduct in the care and use of animals.

• mention important ethical guidelines and regulation for ethical use of animals in pre-clinical research purpose
• Mention the roleand guidelines of animal ethics committeefor ethical use of animalsfor research purpose