(301) 496-7005, within 24 hours 
of the event. An Adverse Drug 
Reaction Form must be sent to 
the principal investigator and 
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 
5.522) Life-Threatening Events (Grade 
4) (ECOG Common Toxicity 
Criteria (Table 2) ) : 
A telephone call must be made 
to the principal investigator 
at 263-1836 and 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 principal 
investigator and the OPRR 
within 10 working days (see 
5.221 for the address). 
5.523) First Occurrence of a Toxicity 
The first occurrence of a 
toxicity (not previously 
reported) , no matter what the 
grade (1-5) , must be reported 
by phone to the principal 
investigator and the OPRR, 
Charles R. McCarthy, (301) 496- 
7005, within 24 hours of the 
event. An Adverse Drug 
Reaction Form must be sent to 
the principal investigator and 
the OPRR, Charles R. McCarthy, 
(301) 496-7005 within 10 days 
working days. 
Recombinant DNA Research, Volume 15 
[479] 
