1- The CAB at our site has a Review committee which is involved in the review of both informed consents and protocols, in one of the recent ICF reviews the committee made recommendations on the wording for the amount of blood to be drawn they recommended that after mentioning the amount of blood to be drawn we should put in brackets the equivalent in table spoons , they advised would help the participants to have a picture of the quantity of blood that will be drawn.
2- Even when a protocol has been sent in its final form the CAB still sits down and reviews the protocol , if and when there are concerns that they feel need to be addressed they are documented and filled at the sites IRB, the site then has a meeting with the review committee to pave a way forward and where need be amendments sent for the review.
