It should be noted that access to the subject’s medical notes could be used by the study team and monitor to verify the required medical history of the healthy volunteers as per the protocol. Assuming the university trial team are documenting all the trial data directly into the CRFs as the source data, then there would be no need to access the medical notes except to review medical history. In addition, if the trial is not based within a hospital setting, as the medical notes belong to the Trust, it is unlikely the university study team would be allowed to record anything in the medical notes.