Document Yj116y0epevdVR3Vz8kyaVLDn

DRAFT CINPATHOGEN CONTRACT MILESTONES This document spells out the expectations of the Study sponsors with regard to the contract for supplemental funding to CinPathogen for completion of the Shanghai Health Study, Consistent with the original scope of work for the Study and grant~ the designj performance and conclusions of the Study are in the sole control of the principal investigators. The milestones laid out in this document are not intended to change that, or in any way to request or require divulgence of data or interim results to the sponsors prior to acceptance of manuscripts for publication in scientific journals_ Tile purpose of requesting the milestone reporting set forth ilerein is for the sole purpose of allowing tile Study sponsors Oversight Committee to fulfil! its obligations to monitor costs and the progress of the study, with !lumbers of cases reported and oth~~1~~ctors used as benchmarks of study progress. .. . . . . . . . . . . . secou~~~~~r,1. Short-term milestones to be achieved in the 2007 a. In May 2007, provide an update of the numb~~bt AIVI~~Qd lymphoid neoplasms (WHO 2001) that can be used in the cas~~~Qnfrol study:. b. Reestablish case accrual at participatifl~~KEmghai Hospitalii. i. Provide an accounting of th~~~~Aber of participatingn~~~!.tals before and after the transition to IBSJ~~~hame?). <.. .............................. ii. Provide an estimate for ccis~~Qcrual in~~{AML and Iymph~!), 3Q, and 4Q (lymphoid only) and provj~~~D up~~~~of the numbers o(cases that can be used in th~ case-contrOl~~~~~~h a quarterly basis (approximately iii. ~~~~li~~~r~=~g1~~~'i~;~~e2v~~!~ik~i~!~?1 work history questionnaires by Dr. Otto Wong"~~9 Ris~~Qiates aS~~~~ssary* c. Continue necessary expos~~~assesm~tlt~ctiviH~~~pr completion of the job- exp~~u~f:~l~l~i~Qtation~;~~~~~~~~~~~I~~fu:~t activities until June 2008 .~~quarterl~~~ports on~~gress toward those goals to the QA team. .~Rbw - Talkt~Rob Schn~~t~r] d. provld~~Qcument~~!~~ of data fld~;gata entry, and roles and responsibilities within th~ibangb~!OO~~i~bi~~gy f6~~eview by the QA team . ...................L Asp~~j~!~objecth;e~f~~~~Ateam review will be data handling of it~f~~8t'~.~ ~~~ ~~:~~~~~~r~ ~~~;ation to ensure that potential cases * In~~~~~ration with th~;~~~pe~~~~~~AlQC team ~:~!!'!:m milesto~l~ito2. CO:Plete the case accrual work by the end of 2007 and the entifi~~~dy~J~he end of 2008. a. Provli~~~~pplied Health Sciences by mid-September 2007* a test data set consisn~of all diagnosed and verified AMLs and lymphoid neoplasms (WHO 2001) and their matched controls, including detailed subtype diagnostic classifications, potential confounders and job-exposure matrix, and all questionnaire information (such as medical histories, family histories, lifestyle information, etc.) for testing the case-control protocol and for developing analytical programs. [ROW - Talk to Rob Schnatter/Otto Wong] b. Provide to Applied Health Sciences by July 1,2008* a final data set consisting of all diagnosed and verified AMLs and lymphoid neoplasms (WHO 2001) and their matched controls, including detailed subtype diagnostic classifications, potential confounders and job-exposure matrix, and all questionnaire information (such as 1 SHELL-MCCLURG-060131 DRAFT CINPATHOGEN CONTRACT MILESTONES medical histories, family histories, lifestyle information, etc.) for completion of the case-control protocol. c. Complete a study cohort of those cases diagnosed prior to December 31 , 2007 of hematopoietic and lymphoid neoplasms (WHO, 2001) 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 CinPathogen's March 18, 2007 DPME proposal, Section 8.1 ii. Documented informed consents and work histg~guestionnaire administration for all cases and controls ................. iii. Cases of AML will be accrued through Jl!n~~, . 2007 iv. Cases of lymphoid neoplasms will be C;!~~~~*Qrough December 31 , 2007 d. Complete a benzene job-exposure case-control study. The matrix will . ~~~~s ~~~~~htrols used in the task, indJ~~~c;!nd time period in developing exposure estimates to Data sources fOf'~~p.osure assessment including the IPHS Yang the~hjnese literature, real-time monitoring in e. If possible, describe all eligible participating hospitals, did not interviewed, including f. manuscript(s) presenting the guidelines in 3.1-A by November 1, g. scientific journals manuscript(s) presenting protocol following the guidelines in proposal, Section 3.1-A by November 1, independent QA/QC team. progress to the Scientific and Ethics Review Study sponsors, and API. The update should include submitted to the SRP/ERP for their review. [Dr. Irons the number of "projected" publications?] upon in cooperation with the independent QA/QC team. 2 SHELL-MCCLURG-060132