Document O6zM6xeggM1r3N7MdE78Y9aw

communicated to 1) the patient's clinical record and attending physician, and to the Case Control and Disease Progression data bases. It is likely that some study subjects (%) will be found to possess constitutional (i.e. congenital) chromosome abnormalities during cytogenetic analysis for acquired chromosome changes in bone marrow and lymph nodes. In these cases, the ICMRC laboratory will inform attending physicians of these fmdings, will offer confIrmatory cytogenetic studies on mitogen-stimulated peripheral blood lymphocytes, and will make appropriate recommendations to referral physicians for genetic counseling and genetic clinical evaluation consistent with standards of medical practice in China. 6.2 Regulatory Guidelines and Practice This study design, review and conduct is being carried out according to Good Epidemiology Practice (GEP) guidelines with specifIc enhancements as detailed in the Council for International Organizations of Medical Sciences Guidelines (CIOMS 1991,1993) and writings by Brody (1998). Because this is a Multinational Study to be conducted in China, harmonization of clinical laboratory regulatory standards and procedures is required. As much as possible, all procedures performed in the FUMC/UCHSC Joint Clinical and Molecular Laboratory will be carried out in according to the practice standards outlined by the College of American Pathologists (CAP), including QC/QA, with documentation. Different countries have approved different methods and procedures for automated clinical instrumentation and software. Where there are differences, clinical instrumentation and software will be confIgured to meet Chinese regulatory requirements in preference to US FDA requirements. In compliance with CAP guidelines, immunochemistry and FISH procedures will be performed using automated staining protocols and processing of slides for immunophenotyping, automatic FISH analyses on the paraffm-embedded tissue sections and DNA/RNA isolation from tissue sections. This study will be conducted according to the regulations set forth by the International Collaborative Programme for the use of Chinese Genetic Resources. Study research design, informed consent and clinical protocols outlined in this study as well as protocol amendments affecting study subjects or source data will be subject to review by the COMIRB. The PI will provide the COMIRB with the research proposal, proposed consent forms, questionnaires, data collection forms, subject recruitment materials, scientifIc and ethical evaluations, as well as progress reports. The PI will also report to the COMIRB any injury, deaths or unexpected adverse experiences encountered by study subjects as a consequence of their participation in this study. In addition, case series of disease prevalence and diagnosis may be published by the ICMRC consistent with Chinese and international guidelines. 7 REFERENCES Literature Cited 1. Hayes, R. B., Linet, M., Dosemeci, M., and Yi, S.-N. Re: Benzene and the Dose-Related Incidence of Hematologic Neoplasms in China. lNatl.Cancer Inst., 90: 469-471,1998. 2. Dosemeci, M. Retrospective exposure assessment in large occupational cohort studies in China: advantages and concerns. Ann Occup Hyg, 43: 377-379, 1999. 29 SH ELL-MCCLU RG-059474