• The medical record is a key element of study subject care. It ensures that an ongoing record of information relating to the study subject, visit records, test records, medical history, diagnoses, treatments etc. are available to the treating physician and his or her colleagues or peers who may intervene in the care of the study subject or take over that care. As such it has a role before, during and after the clinical trial per se.
• Any information that would routinely be expected to appear in a medical record should continue to appear there during the study to ensure the care of the study subject is maintained.
• The fact that the study subject is in a clinical trial, its identity and any specific information over and above the routine that impact on the study subject care should also appear, or be clearly referenced and readily available to the care giver.
• The medical record may also be the first place in which trial related data is recorded and as such becomes by definition the source document for that data.
• It may also be the main point of information on medical history for the purposes of the study, even if that information was originally recorded elsewhere.
• The medical record should provide sufficient baseline information to permit the investigator to enroll the study subject in the trial with due recognition of the needs of medical care and in compliance with the protocol.
• The medical record is also the common point of confirmation of study subject identity and demographics.
