All Study Documentation pertaining to the conduct of the 
study must be kept on file by the investigator for a 
minimum of two (2) years after being notified by the 
sponsor of either PMA approval or discontinuation of 
their IND. 
13.5.4 Study Termination 
The investigator will complete patient enrollment into 
this study in satisfactory compliance with the protocol 
within 2 years after receipt of initial supplies. 
Specific instances which may precipitate termination are: 
a) Unsatisfactory patient enrollment with regard to 
quality and quantity (i.e. if less than 2 patients are 
enrolled in any 1 year of the study). 
b) Deviations from protocol. 
c) Inaccurate and/or incomplete data recording on a 
recurrent basis. 
d) The incidence and/or severity of adverse reactions 
in this or other studies indicating a potential health 
hazard caused by the device. 
13.6 Patient Privacy 
The sponsor is concerned for the individual patient's privacy 
and, therefore, all patient data will be identified only by initials 
and number. The data will be blinded correspondingly in all 
data analysis. However, in compliance with Good Clinical 
Practices, the monitoring of clinical studies and in fulfillment of 
its obligations to the sponsor, it is requested that the investigator 
permit the study monitor to review that portion of the patient's 
medical record that is directly related to the study. 
This shall include all relevant study documentation including 
subject 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 subject is on-study, and autopsy 
reports for deaths occurring during the study (if available). 
As part of the required content of informed consent, the subject 
must be informed that his/her medical chart may be reviewed by 
the sponsor, or the sponsor’s authorized representative. Should 
access to the medical record require a separate waiver or 
authorization, it is the investigator's responsibility to obtain 
such permission from the subject in writing before the subject is 
entered into the study. 
Recombinant DNA Research, Volume 20 
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