Document JvpQQRvkKjkZxOEeevdg79pEr

DRAFT December 22, 2006 Charter for Shanghai Health Quality Assurance and Data Transfer 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 sugplying further quality assurance of data collected as well 91~rigorous quality assurance program for data transferred t9~I~er principal investigators. A multi-year study, the Sm~ngM@iHealth Study has three principal investigators (PI)~~tudy datgq~~es in two countries, a clinical diagnostic laQ~I~tory deliveririgi~formation to a hematologist, an investigati~lrndust~j~L hygienetl~m and an epidemiologist. The team will be made U.~~fol;~members: Members: R~~;~~ir of SRP Ird~~>Hematdlogist, PI ~~pidemiologist, PI n~puality Assurance Expert ....>Industrial Hygienist, SRP Schnatter - Epidemiologist, Adjunct PI be added as the team recognizes the need will ensure processes are in place to provide for data quality control in this complex multi-part These processes shall ensure the quality of the data including during its transfer between investigators. The quality of the data will be assured by using fully reviewed and documented data quality and data transfer processes. Processes will be developed to further delineate roles and responsibilities. These procedures will result in enhanced communication and scientific excellence. SH ELL-MCCLU RG-062025 Deliverables: The team will determine appropriate metrics for delivery to the team on the 15th of each month. Metrics considered reflective of the progress of the study might include: Regular, periodic review of data Documentation of data flow and data entry Cases accrued: AML and NHL Percent of consent forms and questionaires signed Percent of consent forms/questionaires entered into database ... Development of QA/QC progrimfor final year Other metrics deemed nec~~I~fY by the team Timeline: 1~~i~~~~ .First metrics report - March The PI's will implement ~A/QC t~:~j . Note: in or;::!i~~I:::protOCO'S Draft Authors: J.B.Galvin and SH ELL-MCCLU RG-062026