ABSTRACT
Clinical trials in human subjects are performed in addition to the physician-patient interaction, not as a substitute. The underlying premise is that the patient is treated, and information is recorded on the office charts, as if the study did not exist. The patient's case history should contain adequate and accurate observations and other data pertinent to the study, and it remains the property of the practitioner or the hospital. Case Report Forms (CRFs) are used to record the data required by the protocol and to submit the data to the sponsor for data entry and analysis.
