a CT scan will be performed every 3 months during the first year and every 
4 months during the second year and every 6 months during the third year. 
4.12 PROCEDURE FOR REPORTING ADVERSE REACTIONS: 
A. Death of any patient receiving treatment, even if the death does not appear 
to be related to the treatment. 
B. Any serious (life threatening) and unexpected adverse reaction in a patient 
receiving treatment, even if the reaction is not clearly related to the treatment. 
C. The Principal Investigator will notify the Institutional Review Board, the 
Recombinant DNA Advisory Committee (RAC), and the FDA of any serious 
adverse effects within the following time frames: 
1. Written report within 10 working days of all adverse reactions 
that are serious and unexpected. 
2. Within 3 days the FDA will be notified by telephone of any 
unexpected death or life threatening experience. 
All adverse reactions will be entered on the case report form. 
4.13 STUDY MONITORING: 
All records pertaining to the study will be kept on file following conclusion of the 
study. All case report forms, including pre-study, on-study and off -study forms will 
be available for review by the FDA. Survival status, time and location of disease 
progression, and additional treatment will be reported quarterly on post-study follow 
up forms. 
4.14 INFORMED CONSENT: 
Approved informed consent forms will be signed and witnessed for each patient 
entering the study prior to initiation of treatment. The forms will be kept with the 
case report forms and copies submitted to the clinical monitor. 
4.15 INSTITUTIONAL REVIEW BOARD: 
Prior to initiating the study, the Principal Investigator will obtain and comply with all 
requirements of his respective IRB committee. The IRB will be informed of all 
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