20 Ways to Improve Your Pt Case Review Audit 6-09

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English

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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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Publié par	Baheh
Nombre de lectures	22
Langue	English

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P2a0t ieWnaty Cs atsoe I Rmepvrioevwe AYuoduirt Barbara Barrett, MS, CCRPCALGB Audit Program ManagerCALGB Summer Group Meeting, June 2009For CALGB Participants Only

PaStiixe nCta tCeagsoer iRees vfioerw 1. Informed Consent2. Eligibility3. Treatment4. Disease Outcome/Response5. Adverse Events6. General Data Management QualityFor CALGB Participants Only#20: Informed ConsentSlide 3Confirm 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 patients ICF beforeregistration.For CALGB Participants OnlySlide 4

#19: EligibilitySecure all outsideeligibility documentation of diagnostic reports, progress notes, past treatment and/or pathology review beforepatient registration.For CALGB Participants Only#18: EligibilitySlide 5Review required surgical resection and path reports for meeting eligibility criteria. (e.g., 79803)For CALGB Participants OnlySlide 6

#17: EligibilityUse a second set of eyes to review documentation for eligibility criteria beforeregistration.For CALGB Participants Only#16: EligibilityAssure answers to stratification questions are accurate beforeregistration.For CALGB Participants OnlySlide 7Slide 8

#15: TreatmentAlways review patients side effects prior to writing chemo orders for each cycle.For CALGB Participants Only#14: TreatmentSlide 9Double check administration times e.g., Cycle 1 over 90 min, all others 30 min. (S0518)For CALGB Participants OnlySlide 10

#13: TreatmentIf question in dose reductions vshold, contact Study Chair and save documentation of correspondence.For CALGB Participants Only#12: TreatmentOral medications need clear documentation of:1) order2) dispension3) adherenceFor CALGB Participants OnlySlide 11Slide 12

#11: Disease Outcome/ResponseFor response criteria, follow the protocol directed requirements, obtaining the response results at the time points required, even in the post-treatment follow-up setting. For CALGB Participants OnlySlide 13#10: Disease Outcome/ResponseRefer to protocol definition of rpeosinpto. n sTeh iws itcha ne adcifhf erre sbpetownseee nti me protocols.For CALGB Participants OnlySlide 14

#9: Disease Outcome/ResponseFor measureable disease, ALWAYSuse baseline as comparison for response and utilize same mode for comparison, i.e. CT against CT.For CALGB Participants OnlySlide 15#8: Disease Outcome/ResponseRemember several studies require response Confirmatory Scans.For CALGB Participants OnlySlide 16

#7: Adverse EventswNiethv etrr egatuiensg sinvcelsatriigfayt aolrl. AE grades For CALGB Participants Only#6: Adverse EventsSlide 17Confirm documentation of AE grades for dose modifications.For CALGB Participants OnlySlide 18

#5: Adverse EventsRefer to protocol for each unexpected AE for AdEERSand IRB submission instructions.For CALGB Participants Only#4: General Data QualitySlide 19For accurate staging selection on data forms, confirm choices with the attending physician.For CALGB Participants OnlySlide 20

#3: General Data QualityReview Data Submission requirements for study required imaging/radiology reports submissions. For CALGB Participants Only#2: General Data QualitySlide 21Confirm protocol required Bone Marrow (BM) sample submissions with each scheduled BM along with study required stained and unstained slide submissions. For CALGB Participants OnlySlide 22