Document oex72Dp65ebB1b9mkEjY2M16X

To: From: Cc: Bcc: Received Date: Subject: AM EST Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com> Galvin, Jennifer B <Jennifer.B.Galvin@conocophillips.com> 2007-02-09 17:52:07 GMT FW: Shanghai Health Study - Materials for the conference call Friday, February 9, 10 Patsy, Per your request, the only change I saw in Brian's document was the addition of the blue word "continued" which he substituted for "development". I think this is a good catch. The rest appeared unchanged. Thanks, Jennifer Galvin 918-661-3865 918-662-1139 (fax) 918-519-6302 (cell) -----Original Message----From: Galvin, Jennifer B Sent: Friday, February 09, 2007 10:56 AM To: mfitzsim@steptoe.com Subject: FW: Shanghai Health Study - Materials for the conference call Friday, February 9, 10 AM EST Here is the only change on this document that I heard the OC recommend. Thanks for your help and taking the "hot seat". Thanks, Jennifer Galvin 918-661-3865 918-662-1139 (fax) 918-519-6302 (cell) -----Original Message----From: brian.e.doll@exxonmobil.com [mailto:brian.e.doll@exxonmobil.com] Sent: Thursday, February 08, 2007 10:01 PM To: BHRC Communications Committee; BenzConsort-OC@listserve.api.org; BenzConsort-TC@listserve.api.org; Howard Feldman; Russell White Subject: Re: Shanghai Health Study - Materials for the conference call Friday, February 9, 10 AM EST We would like to propose an alternative to the draft letter to Dr. Irons that Russ had distributed previously which we believe includes some incorrect information. The alternative draft is shown below along with the attachment that contains a few minor revisions. I look forward to discussing this with you tomorrow. Regards, Brian Doll SH ELL-MCCLU RG-062049 ExxonMobil Dear Dr. Irons, I am writing on behalf of the group of companies supporting the scientific and clinical research you are conducting in China. We appreciate your serving as principal investigator of this unique project in Shanghai. We are preparing funding in the amount of $6,159, 864 (?) in response to your request for additional support. We assume that the substantive provisions of our original agreement will be in any subsequent contracts necessary to enable completion of the study. We are also providing additional funding for QA/QC as was outlined in your original proposal. As you have suggested, Dr. Jerry Rice, chair of the Scientific Review Panel, as well as other colleagues, have agreed to assist in this effort as well. We would also appreciate receiving a contract proposal from CinPathoGen and its agreements with the University of Colorado and Fudan University. Please forward at your convenience. Sincerely, (See attached file: Shanghai Health Data and Process Quality Assurance2.doc) "Russell White" <whiter@api.or To g> <BenzConsort-OC@listserve.api.org>, <BenzConsort-TC@listserve.api.org>, "BHRC Communications Committee" 02/06/0702:33 <benzconsort-cc@ listserve. api. org> PM cc "Howard Feldman" <Feldman@api.org> Subject Shanghai Health Study - Materials SH ELL-MCCLU RG-062050 for the conference call Friday, February 9, 10 AM EST Shanghai Letter to Irons ROW edits. DOC Shanghai Health Data and Process Quality Assurance. doc Attached is a draft of the "conditions letter" and the QA team charter for discussion on Friday. There is a conference call scheduled for Friday, February 9, at 10 AM EST to discuss the Shanghai Health Study. Draft Agenda 1) Establish quorum and note taker - Patsy 2) Antitrust reminder - Mark 3) Communications Committee update - Trisha 4) Conditions letter update - Jennifer/Russ 5) Contract issues update - Howard 6) QA Team update - Jennifer 7) Next call or meeting - Patsy Conference call: Toll Free Dial-In Number: (866) 443-0059 International Dial-In: (770) 765-9147 Enter this code at the prompt: 202 682 8344# Operator-Assisted Service: Toll-Free Dial-In Number: (800) 572-9844 International Dial-In Number: (706) 643-1733 Call Participant Functions *0 Operator assistance *6 Mute your own line Russell White Regulatory and Scientific Affairs American Petroleum Institute SHELL-MCCLURG-062051 1220 L Street NW Washington, DC 20005-4070 Tel: 202-682-8344 Fax: 202-682-8270 [attachment "Shanghai Letter to Irons ROW edits. DOC" deleted by Brian E DoIl/FairfaX/Mobil-Notes] [attachment "Shanghai Health Data and Process Quality Assurance. doc" deleted by Brian E DoII/FairfaX/Mobil-Notes] Attachments: Shanghai Health Data and Process Quality Assurance2.doc SH ELL-MCCLU RG-062052 DRAFT January 31 , 2007 Shanghai Health Study Charter: Data and Process Quality Assurance Team Purpose: The purpose of this team is to facilitate the successful completion of the Shanghai Health Study through contintl*"J;d implementation and management of a rigorous data, process quality assurance and control program and timely slu:~cessful tmnsition of data to the principal Immstlgators(PI), tl1!'r,i~~;nciPalA multi-year study, the Shanghai Health Study has investigators (PI), study databases in two countrie~~i'th'ical diagnostic laboratory delivering information to a hematologil~an<iq~~stigative industrial hygiene team and an epidemiologist. ...... ......... The team will be made up of the fOllowing~~~~ers: Members: Dr. Jerry Rice, Chai~~I~~.Chair:~ISRP Dr. Richard Irons - HelTla1~IQfd,t; PI Dr. Otto Dr. Judy pidemiotog!t, PI ality AS.Qf:'~nce Expert Dr. Helmut G Dr. Rob Sch 10gist;lep ist~Adjunct PI recognizes the need process quality assurance and g (defined processes, roles and ject timeline with goals & cs to provide oversight and assurance for: control are robust and sustained transfers are done in a timely, accurate, an secure manner gress reporting is on-time and accurate ns and collaboration among investigators occurs facilitates study completion (5) P Y define roles and responsibilities (6) QA/QC p..,..,..t!IIl"Iures will result in enhanced communication and scientific excellence (7) The PI's will implement recommendations of the QA/QC team Deliverables: 1. QA/QC metrics, goals & milestones 2. Progress tracking, submission of status against metrics, goals and milestones to the Oversight Committee on the 15th of each month. SH ELL-MCCLU RG-062053 3, Metrics, goals and milestones which reflect the progress of the study and may include: Documentation of data flow and data entry Accrued Cases1: AML and Lymphoid Neoplasms (WHO) Number of consent forms and questionaires signed, entered into database, presented in running cumulative total Regular, periodic review of usal?:!e data and processes ................ Progress on key milestone~,"a goals Process: Timeliness and. gtiiQ~@cy of data collection, analyses and entry intol~iaba$.~. Number of data aucm~~.pl'ocess I'~'.yvs, and QA review meetings..> ................. Continuation q11~QC program for retijgti(1der of study ............... .. ............ Indicator of stafft~iininglrttl continuity Other l)'Ietrics dee.n~~~tessary by this team Timeline: First metric~~iil~~M~rc~~~~~Q07 Note: Semi-annual, progr~~~re~:~~I~R~~~~i~d in original protocols to b~~~I~jaed ,"...> Draft Authors: Revisions 1 Definition of "accrued cases" indicates only those cases that will be used in the case control study for the Shanghai Health Study. SH ELL-MCCLU RG-062054