Document mpQdnKE6mqppypgLQdYGGeoeB

DRAFT CINPATHOGEN DELIVERABLES Within five calendar days of the receipt of funds, Cinpathogen will identify progress milestones to be achieved in the second quarter, 2007; 1. Update of the estimated NHL case numbers by ICD-9 classification in May 2007. [I would recommend dropping this deliverable and instead request updates based on lymphoid neoplasms (WHO) with documented informed consents and work history questionnaire administration for all cases and controls,] 2. Documentation of data flow and data entry for QA team a. Including review of SOP for data handling of work history information by the QA/QC team (including data-out, e.g., the virtual link between diagnostic data and exposure history data.) 3. Reestablish case accrual at participating Shanghai a. Finalize arrangements for review of original Otto Wong or his associates as necessary* 4. Reestablish necessary exposure assessment of exposure matrix *In cooperation with the independent QA/QC Within fourteen calendar days of the receipt of deliverables and milestones to be in the Cinpathogen to successfully entire study by the end of 2008. the enhanced Quality Assurance/ Cinpathogen proposals of March 18, and costs and the post for the explicitly recognized of a contract with by the end of 2007 and the should be consistent with to the partial laboratory transition task findings should be 1. of hematopoietic and lymphoid set of controls from participating consents and work history questionnaire for cases and controls will be accrued until June 30, 2007 neoplasms will be accrued until December 31 , 2007 2. assessment matrix for all study cases and controls. The matrix industry and time period in developing exposure estimates to benzene. sources for exposure assessment including the IPHS data set, Yang Pu database, the Chinese literature, real-time monitoring in selected factories and simulations will be used to arrive at credible benzene exposure estimates. 3, A substantial preliminary data set (including AMLs and lymphoid neoplasms by WHO criteria, confounders and the exposure assessment matrix) for testing the casecontrol protocol to Applied Health Science by September 2007*. [No ICD-9 classifications are being delivered for the case-control study.] 1 SH ELL-MCCLU RG-062075 DRAFT CINPATHOGEN DELIVERABLES 4. A final data set (including all cases of AML and lymphoid neoplasms diagnosis during the study by WHO criteria, confounders and the exposure assessment matrix) for completion of the case-control protocol to Applied Health Sciences by June 2008*. [No ICD-9 classifications are being delivered for the case-control study.] *Based on a timeline agreed upon in cooperation with the independent QA/QC team and Dr. Otto Wong. Disease Progression Studies 1. Publication quality manuscript(s) presenting the protocol by November 1, 2008 following guidelines DPME proposal, Section 3.1-A. Disease Progression March 18, 2007 Molecular Epidemiology Study 1. Publication quality manuscript(s) Epidemiology protocol by March 18, 2007 DPME proposal, Project Management 1. Implementation of the Cinpathogen (Red Cavaney 2. 3. 2 SH ELL-MCCLU RG-062076 To: BenzConsort-OC@listserve.api.org <BenzConsort-OC@listserve.api.org>; BenzConsort-TC@listserve.api.org <BenzConsort-TC@listserve.api.org> From: Howard Feldman <Feldman@api.org> Cc: Bcc: Received Date: 2007-04-1621 :06:43 GMT Subject: FW: Shanghai Health Study materials >> Russell White Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070 Tel: 202-682-8344 Fax: 202-682-8270 Attachments: CINPATHOGEN DELIVERABLES DRAFT 4-14-07.doc GAP analysis 4-14-07.doc SH ELL-MCCLU RG-062077 DRAFT CINPATHOGEN DELIVERABLES Within five calendar days of the receipt of funds, Cinpathogen will identify progress milestones to be achieved in the second quarter, 2007; 1. Update of the estimated NHL case numbers by ICD-9 classification in May 2007. [I would recommend dropping this deliverable and instead request updates based on lymphoid neoplasms (WHO) with documented informed consents and work history questionnaire administration for all cases and controls,] 2. Documentation of data flow and data entry for QA team a. Including review of SOP for data handling of work history information by the QA/QC team (including data-out, e.g., the virtual link between diagnostic data and exposure history data.) 3. Reestablish case accrual at participating Shanghai a. Finalize arrangements for review of original Otto Wong or his associates as necessary* 4. Reestablish necessary exposure assessment of exposure matrix *In cooperation with the independent QA/QC Within fourteen calendar days of the receipt of deliverables and milestones to be in the Cinpathogen to successfully entire study by the end of 2008. the enhanced Quality Assurance/ Cinpathogen proposals of March 18, and costs and the post for the explicitly recognized of a contract with by the end of 2007 and the should be consistent with to the partial laboratory transition task findings should be 1. of hematopoietic and lymphoid set of controls from participating consents and work history questionnaire for cases and controls will be accrued until June 30, 2007 neoplasms will be accrued until December 31 , 2007 2. assessment matrix for all study cases and controls. The matrix industry and time period in developing exposure estimates to benzene. sources for exposure assessment including the IPHS data set, Yang Pu database, the Chinese literature, real-time monitoring in selected factories and simulations will be used to arrive at credible benzene exposure estimates. 3, A substantial preliminary data set (including AMLs and lymphoid neoplasms by WHO criteria, confounders and the exposure assessment matrix) for testing the casecontrol protocol to Applied Health Science by September 2007*. [No ICD-9 classifications are being delivered for the case-control study.] 1 SH ELL-MCCLU RG-062078 DRAFT CINPATHOGEN DELIVERABLES 4. A final data set (including all cases of AML and lymphoid neoplasms diagnosis during the study by WHO criteria, confounders and the exposure assessment matrix) for completion of the case-control protocol to Applied Health Sciences by June 2008*. [No ICD-9 classifications are being delivered for the case-control study.] *Based on a timeline agreed upon in cooperation with the independent QA/QC team and Dr. Otto Wong. Disease Progression Studies 1. Publication quality manuscript(s) presenting the protocol by November 1, 2008 following guidelines DPME proposal, Section 3.1-A. Disease Progression March 18, 2007 Molecular Epidemiology Study 1. Publication quality manuscript(s) Epidemiology protocol by March 18, 2007 DPME proposal, Project Management 1. Implementation of the Cinpathogen (Red Cavaney 2. 3. 2 SH ELL-MCCLU RG-062079 DRAFT CINPATHOGEN DELIVERABLES Within five calendar days of the receipt of funds, Cinpathogen will identify progress milestones to be achieved in the second quarter, 2007; 1. In May 2007, provide an update of the numbers of AML and lymphoid neoplasms (WHO 2001) that can be used in the case-control study. 2. Reestablish case accrual at participating Shanghai Hospitals; a. Provide an accounting of the number of participating hospitals before and after the transition to IBS. b. Provide expectations for case accrual in 2Q, 3Q, and 4Q and provide an update of the numbers of cases that can be used in the case-control study on a nominal quarterly basis (approximately July, October, and 2008.) c. Finalize arrangements for review of original work by Dr. Otto Wong and his associates as necessary* 3. Reestablish necessary exposure assessment of exposure matrix; a. Provide expectations for exposure quarterly reports on progress toward Rob Schnatter] 4. Documentation of data flow, data Shanghai Health Study for review by a. A specific objective should be a for data handling work history information (including data-out, data and exposure hist~I~~t?) link between diagnostic 61)b~I~~ .*In cooperation with the independent : :~I"'lhe :.~.ogenWithin fourteen cale",l@t::: will delineate deliverables and mil~~t9hes tobi~tilizediijt~e potential development of a contract with Cinpathogen to syiissfully co-iilete the c~~ accrual work by the end of 2007 and the entire study by the,b~ of 2008~.mfjese deliveret~!~s and milestones should be consistent with the enhanced QualitYA~~~ranc:;!~~~~!!m~ntrolpf~gram and tie back to the partial Cinpathog~nprQPQsals af.~~~f8, 2bb1a~~~~l'ir5, 2007. Both the laboratory transition task and cost~~~~lf:l@fI~tstudy.ts for the continued publication of study findings should be explisi~!~~~cognizedb~~~ Cin~~~~?gen response. cas~lntrol Study 1.~~~~s diagnosedl~ior to ~ecember 31 , 2007 of hematopoietic and lymphoid neQ~!~ms (WH@~'001 ) and individually matched (2x) sets of controls selected rando~!~.trorT'l~~~entire patient populations at the participating hospitals in Shangfia!~Q~es characteristics will also include: a. Ca.s~selection follows eligibility criteria in Cinpathogen's March 18, 2007 DPME proposal, Section 8.1 b. Documented informed consents and work history questionnaire administration for all cases and controls c. Cases of AML will be accrued until June 30, 2007 d. Cases of lymphoid neoplasms will be accrued until December 31 , 2007 2. An account of all eligible AML and lymphoid neoplasm patients at all participating hospitals, who did not agree to participate or who were not interviewed, including 1 SH ELL-MCCLU RG-062080 DRAFT CINPATHOGEN DELIVERABLES their basic demographic information and reasons for non-participation/non-interview (if available) will be provided. 3. A benzene job-exposure matrix for cases and controls used in the case-control study. The matrix will consider job, task, industry and time period in developing exposure estimates to benzene. Data sources for exposure assessment including the IPHS data set, Yang Pu database, the Chinese literature, real-time monitoring in selected factories and simulations will be used to arrive at credible benzene exposure estimates. 4. A test data set consisting of all available AMLs and 2001) and their matched controls, including classifications, confounders and job-exposure information (such as medical histories, family testing the case-control protocol and for Health Sciences by mid-September Wong] neoplasms (WHO diagnostic questionnaire information, etc.) for to Applied 5. A final data set consisting of all 2001) and their matched controls, classifications, confounders information (such as testing the case-control Health Sciences by by July *Based on a timeline Otto Wong. QA/QC team and Dr. 1. the findings of the Disease Progression in Cinpathogen's March 18, 2007 1. presenting the findings of the Molecular by November 1, 2008 following guidelines in Cinpathogen's proposal, Section 3.1-A. Project 1. of the condition number one and number three in the agreement for advance funding for Cinpathogen (Red Cavaney to Richard Irons, April 11, 2007). 2. Implementation of recommendations from the independent QA/QC team. 3. Provide semi-annual progress report to the Scientific and Ethics Review Panalists and API. The update should include a running list of papers submitted to the SRP/ERP for their review. [How do we include a look at "projected" publications?] 2 SH ELL-MCCLU RG-062081