Can you please provide some guidance on the use of data obtained from patients prior to the signing of a study specific informed consent document, if the data is solely from “standard of care”procedures and was not done for the purposes of the study? For instance, if a patient has tumor scans done as part of their normal treatment and staging, and then shortly after signs a protocol informed consent document, can the protocol sponsor and site use the data obtained from the scans done pre-consent?