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