Would it be expected to be recorded in the medical records that if, for example a subject does not have any of a list of medical conditions mentioned in the exclusion criteria, it is necessary for the Investigator to write down in a source document that those conditions do not exist, or can the monitor / auditor accept that if none of those conditions is mentioned in the medical record, that they do not exist?

Or would it be expected that there would be a brief written statement from the investigator in the patient's medical record (source) to confirm that the ?patient met all study inclusion/exclusion criteria, and that this is sufficient to cover ?negative evidence?