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DRAFT SHS Proposed Budget Revision Oversight Committee December 14, 2006 San Francisco SH ELL-MCCLU RG-067059 Conditions for Additional Funding Additional QAlQC process implemented - SRP Chair leads - Team of Otto Wong, QA/QC Specialist (Judy Baldwin), other SRP members - Total process review and documentation - Checks and metrics put in place - Metrics on "reportable" cases provided monthly to SRP Chair and OC QA/QC team will identify SH ELL-MCCLU RG-067060 Conditions for Additional Funding (Continued) Payments geared to study progress milestones Ensure database backup in the U.S. and availability for use by QA/QC team Total additional funds for SHS will not exceed $9.1 M ($827K1share) SHELL-MCCLURG-067061 Proposed Timeline 1/5/07 -- SHS members make funding decision 1/8/07 -- Funding & conditions relayed to PI 1/31/07 -- QA/QC team identifies metrics 1/31/07 -- Amendment to research agreement drafted and signed by SHS compani.es 3/15/07 -- First metrics report to SRP Chair and OC for Feb. '07 ... additional monthly metrics generated thereafter on same schedule 3/31/07 -- U of Co Grant contract revised by API Case accrual to YE 2007 Data analysis completed by YE 2008 Payment Schedule (U of Co funded through June '07) - First payment 15 Days after receipt of 3/15/07 metrics report - Additional payments to follow upon completion of 300,400, and 500 NHL cases Closing ceremony 4Q'08 Consortium terminated 12/31/08 SH ELL-MCCLU RG-067062 Background -- Case Definitions Accrued Case is "reportable" when: - Finalized diagnosis completed - Consent form completed - Interviews of cases and matched controls completed - All 3 above stored in the database Additional steps to "finalize" data for use: - Stored data is QA'd within the database by QA/QC function - All data for Bz cases translated into English SH ELL-MCCLU RG-067063 3118/07 Proposed Extention of Studies on Benzene Toxicity in Shanghai, China RESEARCH PROTOCOL AND CRITERIA DOCUMENT I. ANALYSIS OF DISEASE PROGRESSION FOR APLASTIC ANEMIA, MYELO- DYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA III. DIAGNOSIS AML AND L YMHOID NEOPLASMS IN SHANGHAI, CHINA A MULTICENTER INTERNATIONAL STUDY Richard D. Irons CINPATHOGEN, INC. BOULDER, COLORADO/SHANGHAI CHINA INTERNATIONAL CLINICAL AND MOLECULAR RESEARCH CENTER INSTITUTES OF BIOMEDICAL SCIENCES, FUDAN UNIVERSITY SHANGHAI, CHINA FUDAN UNIVERSITY MEDICAL CENTER, SHANGHAI, CHINA DEPT. OF PHARMACEUTICAL SCIENCES, SCHOOL OF PHARMACY DEPARTMENT OF PATHOLOGY, SCHOOL OF MEDICINE UNIVERSITY OF COLORADO DENVER AND HEALTH SCIENCES CENTER, DENVER, CO. SHANGHAI HEMATOLOGY SOCIETY SH ELL-MCCLU RG-067064