UAB 9405 
March 16, 1994 
PAGE - 18 
9.0 EVALUATION CRITERIA 
9.1 Adverse Drug Reaction Reporting Criteria 
9.1.1 Report by telephone to FDA Division of Vaccines and Related Products 
within 24 hours (301-594-2090). 
i) All life-threatening events (Grade IV) which may be due to drug 
administration. 
ii) All fatal events. 
iii) The first occurrence of grade 2 toxicity including previously 
unknown clinical event (regardless of grade). 
9.1.2 Written report to follow within 10 working days to: 
Food and Drug Administration 
Division of Vaccines and Related Products 
Dr. Alexander Kuda 
1401 Rockville Parkway, Room 20010 
Rockville, MD 20852-1448 
301-594-5114 (phone) 
301-594-1975 (fax) 
9.1.3 Use the protocol number and IND number for this study on all reports. 
9.1.4 Grading of Toxicity - Grades of toxicity are defined in Appendix A. 
10.0 PATIENT REGISTRATION 
All potential study candidates will be evaluated by the research nurse and the principal 
investigator. After confirmation of eligibility including a positive skin test to recall 
antigens, the patient will be registered and enrolled by calling the Clinical Studies Unit. 
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