QUALITY ASSURANCESTATEMENT
Study Title: UNSCHEDULED DNA SYNTHESIS IN
RAT PRIMARY HEPATOCYTES
Study Number: T5370.380
Study Director: Rodger D. Curren, PH.D.
Initiation Date: 87/03/05
Reyiew Completed Date: 87/08/27
This study has been divided into a series of phases. Using a
random sampling approach, Quality Assurance monitors each of
these phases over a series of studies. Procedures,-dccumenta-
tion, equipment, etc., are examined in order to assure that the
study is performed in accordance with the U.S. FDA Good
Laboratory Practice regulations (2lCFR58). the U.S. EPA GLPs
(40CFR792 and 40cFRl60), and_the OECD guidelines and to assure
that the study is conducted according to the protocol.
The following are the inspection dates; phases inspected, and
report dates of QA inspections of the study.
INSPECTON87/02/23-87/02/23,TOSTUDY DIR.87/02/23,TOMGMT87/02/23
PHASES: PROTOCOL REVIEW
INSPECT ON87/03/05 - 87/03/05,TO STUDY DIR 87/03/06,TO MGMT 87/03/09
PHASES: PRELIMINARY TOXICITY TEST:
COUNTING ANDSEEDING OF35mm.PLATE CULTURES
INSPECT ON87/08/13-.87/08/14,TOSTUDY DIR 87/08/13,T0 MGMT 87/08/27
PHASES: FINAL REPORT
study and the reported results accurately reflect the raw data
of the study.
87150355
Drdle E. C
87/08/31
QualityAssurance
Date
RAyQA Department
Microbiological Associates, Inc.
