1) During a meeting with the CAB to review the initial draft of the study ICF, the CAB read through the IC and documented the things they were not happy and the suggestions that they had. These were all noted and sent to a regulatory representative. Some of the changes were implemented, but not all and these were discussed at a follow up meeting with the CAB members explaining why some things could not be changed in the ICF.

2) The site will still review the protocol with the CAB members and answer and explain any questions and comments they may have. I think having a representative from the sponsor will also be helpful and if there is anything the site cannot answer, it will be escalated to the IRB.