What types of records are considered part of each subject’s case history as defined by federal regulations?Case histories are defined in 21 CFR 812.140(a)(3) and include the case report forms and supporting data including, for example, signed and dated informed consent forms and medical records including 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. | |
|
|
