protocol approval

protocol approval (sponsor)

A clinical trial term of art for a sponsor action that follows completion of protocol development, which is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated.
Approval by the sponsor usually initiates secondary approvals by institutional review boards (IRBs), regulatory authorities and sites. Protocol amendments usually also require a cycle of approval by sponsor and study staff before taking effect.