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Unformatted text preview: Date of Audit: __________ Reviewed by: ______________ Patient ID: _______________ Site: ________________ ___ Site Contact: __________ _ Treatment Arm: __________ Date on Study: ___________ Off Study: __ _ Yes ___ No Baseline Only : ____ Yes ____ No CRITERIA EVALUATION YES NO N/A 1. Is the patient eligible according to protocol criteria? 2. Consent signed prior to and treatment? 3. Randomization administered correctly? 4. Educational sessions took place in specified time frame? 5. Follow-up according to protocol? 6. Hard copies matched data entry copies? 7. If patient is off study, is data collection complete? FINAL ASSESSMENT: Met Requirements Discrepancies Noted Protocol Violation (all marked yes) (those marked no were noted) (answer of no without notes) NOTE: All responses other than "YES" require a written explanation to accompany this form Auditor Signature ______________________________ Date___________________ Project Administrator Signature ______________________________ Date__________________ UNIVERSITY OF CALIFORNIA DAVIS CANCER CENTER SIMULTANEOUS CARE: Linking Palliation to Clinical Trials DR. FRED MEYERS Grant# CA95260...
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This note was uploaded on 12/30/2010 for the course BST 252 taught by Professor Tsodikov during the Winter '06 term at UC Davis.
- Winter '06