Q: Does an IRB Exempt protocol need CSRC review?
A: Yes
Q: Do forms need to be signed prior to submission?
A: Yes, all appropriate signatures are required for CSRC review
Q: Does the protocol go to the CSRC for review prior to being sent to the Cancer IRB?
A: Yes - this is the same for amendments
Q: Does the PI have to present at a CSRC meeting?
A: No
Q: How long does the PI have to respond to a deferral or stipulations?
A: 60 days
Q: What is included in an Amendment Submission?
A: Summary of Changes, marked-up version, new protocol
Q: How long does the PI have to respond to a warning letter?
A: 2 weeks
Q: Do I need to have funding confirmed before I submit my trial to the CSRC?
A: No, however, it is encouraged. The CTO's Office of Contract Development and Coordination provides assistance in developing and negotiating budgets as well as contracts.
Q: Where can I find a list of the Disease Committee Leaders?
A: Scientific Disease Committee Leaders
Q: Can accrual goals be modified?
A: Yes