1. DP Data Flow Process

2. Individual agrees to participate in DP Completed assessment and questionnaire are mailed/FedEx to CC Staff completes assessment; participant and family fill out questionnaires Completed assessment/questionnaires go to DP DC to be checked for completeness/accuracy/errors If incomplete or errors found, DC calls Project Coordinator and Site Data Coordinator DC gives completed form to CC Data Entry personnel Error corrected/information completed No errors found DC logs in notification

3. Project File Organization

4. Order Materials Eligible: Consented Participants Labeling File Drawers: Drawer 1 Labeling File Drawers: Drawer 2 Eligible: Waiting to Consent Possibly Eligible Dropped Out Not EligibleRefused Labeling File Drawers: Drawer 3 Project Forms Labeling the Participant File Participant Record Registry Input Form P/F Baseline Assessments P/F Signed Consent Individual Retention Form Annual Questionnaire s Safety Reports

5. Project File Organization Instructions Instructions Schematic