Document bB8DQ3wYMYdj59mpRGOpozBO3
12 June 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-059570