Document jyYDYdxE6bdaxMYwKR4VX5Q05

To: jennifer.b.galvin@conocophillips.com <jennifer.b.galvin@conocophillips.com>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; whiter@api.org <whiter@api.org>; jarnotb@api.org <jarnotb@api.org> From: Jmricewas@aol.com <Jmricewas@aol.com> Cc: bcsfl@webtv.net <bcsfl@webtv.net>; Richard.lrons@UCHSC.edu <Richard.lrons@UCHSC.edu>; OttoWong@aol.com <OttoWong@aol.com>; helmut.greim@lrz.tum.de <helmut.greim @Irz.tum.de>; a. r.schnatter@exxonmobil.com <a. r.schnatter@exxonmobil.com> Bcc: Received Date: 2007-04-3015:34:40 GMT Subject: Shanghai Health Study April QA/QC update and final QA/QC team charter Hello everyone, I attach 2 documents to this message: a final version of the QA/QC team charter and a brief summary report of QA/QC activities since our March 15 conference call. The final round of suggested changes to the charter were in the nature of wordsmithing rather than substance, and there seems to be no advantage to modifying that document further. I must emphasize that Judy is the only qualified QA/QC expert on the team, and the team is largely dependent on her to make sure that the various charges to the team are properly addressed. Gail Jorgenson's retirement from ExxonMobil as of March 31 leaves a hole in the QA/QC team fabric that needs to be repaired. Rob Schnatter will be the contact individual for the time being for items that previously would have been sent to Gail. With best regards, Jerry ************************************** See what's free at http://www.aol.com. Attachments: Shanghai Health Study QA-QC team charter 4-27-2007.doc Team activities 3-16 through 4-27-2007. doc SH ELL-MCCLU RG-063552 27 April 2007 Shanghai Health Study Charter: Data and Process Quality Assurance Team Purpose: The role of this team is to facilitate successful completion of the Shanghai Health Study through development, implementation and management of an independent data and process quality assurance and control program; to set definable milestones for study completion; and to assure timely transfer of information among investigators. The focus of the Team is to be on the Shanghai Health Study as a whole, rather than on specific protocols, and the team is not expected to duplicate or replace existing QA/QC measures that have already been established by individual principal investigators for individual protocols or other SHS elements. A multi-year study, the Shanghai Health Study has three principal investigators (PI), study databases in two countries, a clinical diagnostic laboratory delivering information to a hematologist, an investigative industrial hygiene team and an epidemiologist. Therefore, this complex study needs a well understood process for the transfer of data from one investigator to another. The team will be made up of the following members: Members: Dr. Jerry Rice, Chairman, Chair of SRP Dr. Richard Irons - Hematologist, PI Dr. Otto Wong - Epidemiologist, PI Dr. Judy Baldwin - Quality Assurance Expert Dr. Helmut Greim - Toxicologist, SRP Dr. Rob Schnatter - Epidemiologist, Adjunct PI **Others can be added as the team recognizes the need Team and PI Responsibilities: Ensure that a rigorous system for data and process quality assurance and control is in place and functioning (defined processes, roles and responsibilities, process reviews, project timeline with goals & milestones, and key metrics) to provide oversight and assurance addressing the following: (1) data and process quality control are robust and sustained; (2) data capture, analyses and transfers are done in a timely, accurate, complete, consistent and secure manner; (3) data tracking and progress reporting is on-time and accurate; (4) effective communications and collaboration among investigators occurs in a way that facilitates study completion; (5) processes clearly define roles and responsibilities; 1 SH ELL-MCCLU RG-063553 27 April 2007 (6) QA/QC procedures 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 a regular basis. 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 usable data and processes Progress on key milestones and goals Process: Timeliness and accuracy of data collection, analyses and entry into databases Number of data audits, process reviews, and QA review meetings Development of an additional external QA/QC program for remainder of study Indicator of staff training and continuity Other metrics deemed necessary by this team Timeline: First metrics report - March 15,2007 Note: Semi-annual, written progress reports as specified in original protocols will continue to be provided by the Principal Investigators. 1 Definition of "accrued cases" indicates only those cases that will be used in the case control study for the Shanghai Health Study. 2 SH ELL-MCCLU RG-063554