Final Subject Report Form - which should reflect the reason the subject 
was terminated from the study and an explanation of the follow-up medical 
care. 
Adverse Experience Report Form - which should explain any serious or 
unexpected adverse experience 
Informed Consent Form - which must be available for each subject and be 
verified for proper documentation 
Study Notes - this section of the Case Report Forms, is utilized to explain 
any aspect of the study that is not easily entered on the routine Case 
Report Forms, and would include such items as: protocol deviations, 
comments or explanations of unusual findings, any data or clarification of 
data not explicitly requested on the case report forms. 
Federal Regulations - requires that all of the items listed under Initiation 
of Study, Maintenance of Study Documentation, IRB approvals, and any 
other docuaments pertaining to the conduct of the study, must be kept on 
file by the Investigator for a minimum of two (2) years after PMA 
approval or discontinuation of the IND. 
17.6 Patient Privacy 
All patient data will be identified only by a patient identification number and 
patient initials to protect the patient’s privacy. The data will be blinded 
accordingly in all data analysis. However, in compliance with Federal guidelines 
regarding the monitoring of clinical studies, it is required that the investigator 
permit a representative of the FDA to review that portion of the patient’s medical 
record that is directly related to the study. 
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Recombinant DNA Research, Volume 15 
