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The sponsor-investigator must maintain accurate case histories that record all observations and other data pertinent to the investigation on each subject who received the investigational drug and each subject who was employed as a control in the investigation. [21 CFR 312.62]. Case histories include the case report forms and supporting data such as signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
The sponsor-investigator carries all responsibilities toward co-investigators that are normally assigned to the sponsor.