2. Project File Organization

3. 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

4. Project File Organization Instructions Schematic