IRB in the following manner described. In addition, a copy of this 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 which is not transplant related and that might 
possibly be related to gene transduction, must be reported as follows: 
The principal investigator or one of his associates must call the OPRR, Charles R. 
McCarthy, (301) 496-7005, within 24 hours of the event. An adverse Drug Reaction 
Form must be sent to the OPRR within 10 working days. 
Charles R. McCarthy 
OPRR 
Building 31, Room 5B-59 
NIH 
Bethesda, MD 20892 
Life-threatening events (grade 4 toxicity') 
The principal investigator or one of his associates must call 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. 
First occurrence of a toxicity. The first occurrence of a toxicity (not previously reported, 
no matter what the grade) felt to be related to gene transduction, must be reported by 
the principal investigator or one of his associates by phone 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 OPRR, Charles R. McCarthy, within 10 working days. 
B. Informed Consent 
The principal investigator or one of his associates must explain verbally and in writing 
the nature of the study and the procedures of GC gene transfer into PBRC in such a 
manner that each patient is aware of the potential risks. The patient must also be 
informed that he/she may withdraw from the study at any time and for whatever reason, 
without prejudice to their future treatment. 
11. Records 
Clinical Statistics maintains a patient database at FHCRC to allow storage and retrieval of 
patient data collected from a wide variety of sources. The investigator will ensure that data collected 
conform to all established guidelines for coding, collection, keyentry and verification. Each patient is 
assigned a unique patient number to assure patient confidentiality. Any publication or presentation will 
refer to patients by this number and not by name. The licensed medical records department, affiliated 
with the institution where the patient receives medical care, maintains all original inpatient and 
outpatient chart documents. Patient research files are kept in a locked room. They are maintained by 
the FHCRC data collection staff which is supervised by an A.R.T. Access is restricted to personnel 
authorized by the Division of Clinical Research. All required clinical evaluation records, analysis of the 
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