PowerPoint Template - 第二军医大学卫生统计学教研室：Health Statistics Department of Second Military Medical University PowerPoint Template.pptVIP

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PowerPoint Template - 第二军医大学卫生统计学教研室：Health Statistics Department of Second Military Medical University PowerPoint Template.ppt

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PowerPoint Template - 第二军医大学卫生统计学教研室：Health Statistics Department of Second Military Medical University PowerPoint Template

* Study level’s validation (cont’d) Study-Specific Programming Every procedure (edit check) needs to be tested kicks out for the appropriate patient, page with the correct output message does not kick out for clean data. * Study level’s validation (cont’d) Study-specific programming Dummy data 2 patients with clean data 6 patients with dirty data Missing data Blank page Every edit check Withdraw As similar as the real data Additional page * Clinical Data Management System 1 Database Validation 2 Change Control 3 Medidata RAVE Demo 4 Agenda * Work Flow Prepares the Annotated CRF and Database Structure specification (Version 0.1) ? A written approval of user list requisition ? A written approval should be made ? The final protocol and CRF Database Develop Validation DM staff review the Database Structure If amendment is needed, the problems and resolutions should be recorded and the database structure should be updated to a new version UAT ?Release Database production Database production work will modify the system, record resolutions and updated database structure specification to a new version and approve it. Validation and UAT Report. If amendment is needed, the problems and resolutions should be recorded and the database structure should be updated to a new version During production Data Management process, if any change is needed, the problems and resolutions should be recorded, change control system ?A written approval * Once the system is in production, any change should be tracked！ * Work Flow-Change Control Any change is needed Database production work Get review or approval for the change A written approval ?A written approval Assess the impact of the change Database Updating Validation UAT ?Release Database production ?A written approval * What is a change? Software systems Applications programs new versions of software bug fixes system or site configuration files or parameters What is a change? User applications F