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20 Ways to Improve Your Patient Case Review AuditBarbara Barrett, MS, CCRPCALGB Audit Program ManagerCALGB Summer Group Meeting, June 2009For CALGB Participants OnlySix Categories for Patient Case Review1. Informed Consent2. Eligibility3. Treatment4. Disease Outcome/Response5. Adverse Events6. General Data Management QualityFor CALGB Participants Only Slide 3#20: Informed ConsentConfirm patient signs most recently approved Informed Consent Form (ICF) and be sure all blanks are completed, IRB required signatures obtained, and initials, etc., are present on the patient’s ICF before registration.For CALGB Participants Only Slide 4#19: EligibilitySecure all outside eligibility documentation of diagnostic reports, progress notes, past treatment and/or pathology review beforepatient registration.For CALGB Participants Only Slide 5#18: EligibilityReview required surgical resection and path reports for meeting eligibility criteria. (e.g., 79803)For CALGB Participants Only Slide 6#17: EligibilityUse a second set of eyes to review documentation for eligibility criteria before registration.For CALGB Participants Only Slide 7#16: EligibilityAssure answers to stratification questions are accurate beforeregistration.For CALGB Participants Only Slide 8#15: TreatmentAlways review patient’s side effects prior to writing chemo orders for each cycle.For CALGB Participants Only Slide 9#14: TreatmentDouble check administration times –e.g., ...
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