Document oexmm32gZnGGxx8MLnkad87bE
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
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SH ELL-MCCLU RG-058952
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?]
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SH ELL-MCCLU RG-058953