16.0 RECORDS TO BE KEPT 
All required clinical evaluation records will be the responsibility of Drs. Malcolm 
Brenner, Robert Krance and Helen Heslop. Analysis of the clinical outcome and 
toxicity will also be their responsibility, (see Section 13.0). 
The laboratory evaluation of retroviral insertion will be the responsibility of Drs. 
Brenner and Ihle. 
Toxicity will be evaluated by the NCI Common Toxicity Criteria (Appendix D) and 
the Dartmouth Hematologic Transplant Criteria (Appendix E). 
Adverse Reaction Reporting Requirements 
This protocol uses retro viral -mediated genetic material which is considered an IND 
agent. Toxicities occurring on this treatment should be considered IND related. 
The following adverse reactions must be reported to the NIH Office of Protection 
from Research Risks (OPRR) and the local IRB in the following manner described. 
In addition, a copy of the report will be forwarded to the NIH Office of 
Recombinant DNA Activities and the US Food and Drug Administration. 
Deaths 
Any death from any cause while a patient is receiving treatment on this protocol or 
up to 30 days after the last dose of protocol treatment, or any death which occurs 
more than 30 days after protocol treatment but which is felt to be treatment related, 
must be reported as follows: 
A telephone call must be made to the OPRR, Charles R. McCarthy, (301) 496-7005, 
within 24 hours of the event. An Adverse Drug Reaction Form must be sent to the 
NIH Office for Protection from Research Risks within 10 working days. 
Charles R. McCarthy 
OPRR 
Building 31, Room 5B-59 
NIH 
Bethesda, MD 20892 
Life-Threatening Events (Grade 41 TECOG Common Toxicity Criteria (Table 4)1 . 
A telephone call must be made to the OPRR, Charles R. McCarthy, (301) 496-7005, 
within 24 hours of any grade 4 toxic event which may be due to the IND agent. An 
Adverse Drug Reaction Form must be sent to the OPRR within 10 working days. 
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