Document wg1pEbj4zpGRBVa68e0wOL15d

To: From: Cc: Bcc: Received Date: Subject: Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com> Wong, Zachary (ZachWong) <ZachWong@chevron.com> 2007-01-1618:36:50 GMT FW: My Input on Shanghai Quality Team Charter! Hi Patsy. I had meant to copy you on my comments to Jennifer on the Charter. Zach ZachWong "There is always time to do it safely" zachwong @chevron.com Manager, Toxicology and Health Risk Assessment Chevron Energy Technology Company 100 Chevron Way, P.O. Box 1627 Richmond, CA 94802-0627 (510) 242-7011 Fax: (510) 242-7022 From: Wong, Zachary (ZachWong) Sent: Monday, January 15, 2007 9:07 PM To: 'Jennifer.B.Galvin@conocophillips.com'; 'Russell White' Subject: My Input on Shanghai Quality Team Charter! Importance: High Hi Jennifer. As we discussed on Friday, I have provided my input on some essential "project management" elements that I feel would help our chances for a successful completion of the study. See attached revised Charter with my edits in blue. Thanks.... and pis confirm receipt. I'm out on Tuesday but in the office on Wed and Thursday this week. Regards, Zach ZachWong "There is always time to do it safely" zachwong @chevron.com Manager, Toxicology and Health Risk Assessment Chevron Energy Technology Company 100 Chevron Way, P.O. Box 1627 Richmond, CA 94802-0627 (510) 242-7011 Fax: (510) 242-7022 Attachments: Shanghai Health Data and Process Quality Assurance. doc SHELL-MCCLURG-061934 DRAFT January 15, 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. This team will facilitate progress of this study by developing and instituting a rigorous data and process quality assurance program for data management. A multi-year study, the Shanghai Health Study has thre~~~ncipal investigators (PI), study databases in two countries,i,linical diagnostic laboratory delivering hygiene team and an information to a epidemiologist. hematologi~~~i~lnvestigative ........... .......... industrial m.~6~;s:The team will be made up of the following Members: (I think the team is too large -5Jiiil6Id be better) Dr. Jerry Rice, chai;~~~~>chair:@'SRP Dr. Richard Irons - Hemat@IQg~~t;>PI Dr. Otto EpidemiofQg!~t, PI Dr. Judy uality A~g(ance Expert Dr. Helmut G rial Hyg,@nist, SRP Dr. Rob Sch ist~Adjunct PI recognizes the need ned processes, roles and line with goals & milestones, quality are maintained; facilitate study timeline n principal investigators. The quality of the data and processes will be red by using fully reviewed and documented data quality and data transfer processes and periodic audits. Processes will be developed to further delineate roles and responsibilities. These procedures will result in enhanced communication and scientific excellence. Deliverables: The team will determine appropriate metrics, goals & milestones and track progress, and submit them to the team (which team? Is this the Oversight team?) on the 15th of each month. There should be both process and result SHELL-MCCLURG-061935 metrics which reflect the progress of the study and may include: Regular, periodic review of data and processes Documentation of data flow and data entry Cases accrued: AML and NHL Progress on key milestones and goals Process: Timeliness and accuracy of data collection, analyses and entry into database Number of data audits, processxeviews, and QA review meetings .............. Process: Level of investig~t~~~tisfaction Percent of consent forml!ialyestionaires signed Percent of consent formi/questilnflires entered into database . > ... .................................. Development of g~mc program foff!nfll year Other metrics.~.fi1ed necessary by tHe~!.flm Timeline: :~~m.~ ~~1~67First metrics report 1.. The PI's will implement o~i~i~~mc team. :~~~!I!~dNote: in original protocols Draft Authors: J. SHELL-MCCLURG-061936