This shall include all relevant study documentation including patient medical histories to verify 
eligibility, laboratory test result reports to verify transcription accuracy, x-ray reports, 
admission/discharge summaries for hospital/outpatient admissions occurring while the patient is 
on-study, and autopsy report for deaths occurring during the study (if available). 
As part of the required content of informed consent, the patient must be informed that his/her 
medical chart may be reviewed by a representative of the Food and Drug Administration. 
Should access to the medical record require a separate waiver or authorization, it is the 
investigator’s responsibility to obtain such permission from the patient in writing before the 
patient is entered into the study. 
Recombinant DNA Research, Volume 15 
[545] 
