Document zQK3d659g6wzgKq3M6B5xn4wm

DRAFT CINPATHOGEN CONTRACT MILESTONES This document spells out the expectations of API al1d the Study sponsol'S with regard to the contract for supplementa! funcHng to CinPathogen for completion of the Shanghai Hea!til Study, Consistent witil tile original scope of work for tile Study and grant~ tile designj performance and conclusions of the Study are in tile sole control of the principal investigators. The milestones laid out in this document are not intended to change that, or ill any way to request or require divulgence of data or interim results to the sponsors or API prior to acceptance of mal1uscripts for publication ill scientific journals, The purpose of requesting tile milestone reporting set forth herein is for the sole purpose of allowing API and tile Study Sponsors Oversight Committee to fulfill their obligations to monitor costs and the progress of the study~ with numbers of reported and other factors used as benchmarks of study progress, 1. Short-term milestones to be achieved in the a. In May 2007, provide an update of the be used in the case-control study. b. Reestablish case accrual at i. Provide an accounting of after the transition to ii. Provide an estimate for (lymphoid only - should this numbers of that can be quarterly basis iii. Within the new 2007. NHL1 cases that can c. completion of the job- assessment activities until June 2008 toward those goals to the QA team. d. team to fulfill the elements of the QA/QC ,,,,.,nnlot-o the case accrual work by the end of 2007 and 2008. Sciences by mid-September 20073 a test data set and verified AMLs and NHLs and their matched detailed subtype diagnostic classifications, potential available exposure information (such as medical histories, lifestyle information, etc.) for testing the case-control protocol analytical programs. b. Health Sciences by July 1,20083 a final data set consisting of all diagnosed and verified AMLs and NHLs and their matched controls, including detailed subtype diagnostic classifications, potential confounders and exposure assessment data, and all questionnaire information (such as medical histories, family histories, lifestyle information, etc.) for completion of the case-control protocol. 1 Defined here as The WHO classification for lymphoid neoplasms. 2 In cooperation with the independent QAlQC team. 3 Based on a timeline agreed upon in cooperation with the independent QAlQC team. 1 SH ELL-MCCLU RG-064883 DRAFT CINPATHOGEN CONTRACT MILESTONES c. Complete a study cohort of those cases diagnosed prior to December 31 , 2007 of hematopoietic and lymphoid neoplasms (should this be NHL?) and individually matched (2x) sets of controls selected randomly from the entire patient populations at the participating hospitals in Shanghai. Cases characteristics will also include: i. Case selection following eligibility criteria in the March 18, 2007 DPME proposal, Section 8.1 ii. Documented informed consents and work history questionnaire administration for all cases and controls iii. Cases of AML will be accrued through June 3Qj~Q07 iv. Cases of NHL will be accrued through Dec~mb~W31 , 2007 d. Complete a benzene job-exposure matrix for ca~~~nd controls used in the case-control study. The matrix will consider jg~~t~~~~j[ldustry and time period in developing exposure estimates to benzene. <I~j,fi:i s6Uf:. for exposure assessment including the IPHS data set,~~ng<Pu datab~~~,the Chinese literature, real-time monitoring in seleG~~~Ml.ctories and simijj~tjons. e. Submit for publication to appropriat~~~!ehtific journals manUS&tl~~(s) presenting the findings of the Disease Prom~~~!i5h protocol fgllowing the gUI~~!jnes in the March 18, 2007 DPME proposal,<S~~jpn 3.1-A<~iJNovember 1, 2~~< f. Submit for publication to appropriat~~~!~[ltifjGj~ijihals manuscript(s) presenting the findings of the Molecljlar Epidemi0l6g~~t9t6col following the guidelines in the March 18, 2007 DPME~~~~al, Section<3~l~~ by November 1, 2008. g. Implement the recomme~~af:@h.pf the inde~~Qent QA/QC team. h. Provide semi-annual prog~~sre~~~Jg the SCl~~@C and Ethics Review Panelists, Shanghai HealtH~tudy spq~~~~,and<Afflh< The update should include s~~roitt~g~tH~~B!?tERP for their review. 2 SH ELL-MCCLU RG-064884