2-Audit P&P-Susan

2-Audit P&P-Susan

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ÊÊÊCALGB DATA AUDITPOLICIES AND PROCEDURESCALGB Data Audit CommitteeREGULATORY COMPLIANCEIRB review/approval required before entry?Annual review at least every 12 months or <365 days?All updates reviewed as required within 90 days of implementation?CALGB Data Audit Committee1ÊÊÊÊÊREGULATORY COMPLIANCEBroadcast SAEs acknowledged by IRB within 90 days of distribution?Action Letters acknowledged by IRB Audit update and broadcast SAE list on web (resources → audit)CALGB Data Audit CommitteeREGULATORY COMPLIANCEParticipant notification accomplished as indicated?IRB informed of local AERs?(C-804, MedwatchAddendum)CALGB Data Audit Committee2ÊÊÊÊÊREGULATORY COMPLIANCEAdditional ReviewsCompanion studies Closed studies with patients still being followed –Expedited versus Full BoardCALGB Data Audit CommitteeINFORMED CONSENTAll required content present (refer to NCI required consent elements checklist)One risk omitted → MAJOROriginal, signed, witnessed, and dated on or before date of registrationCALGB Data Audit Committee3ÊÊÊÊINFORMED CONSENTEvidence of understanding -interpreter if not mentally competent or non-English speaking All blanks completed (e.g., contact numbers, MD names, etc.) when patient signs the consentCALGB Data Audit CommitteeELIGIBILITYSource documents for each eligibility criterion support the data submitted (including hx of prior Rx or disease; documentation of appropriate PS)Pre-Rx ...

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CALGB DATA AUDIT
POLICIES AND PROCEDURES
CALGB Data Audit Committee
REGULATORY COMPLIANCE
ÊIRB review/approval required before entry? ÊAnnual review at least every 12 months or <365 days? ÊAll updates reviewed as required within 90 days of implementation?
CALGB Data Audit Committee
1
REGULATORY COMPLIANCE
ÊBroadcast SAEs acknowledged by IRB within 90 days of distribution? Êacknowledged by IRBAction Letters within 90 days of distribution? ÊAudit update and broadcast SAE list on web (resourcesaudit)
CALGB Data Audit Committee
REGULATORY COMPLIANCE
ÊParticipant notification accomplished as indicated? ÊIRB informed of local AERs?(C-804, Medwatch Addendum)
CALGB Data Audit Committee
2
REGULATORY COMPLIANCE
Additional Reviews ÊCompanion studies ÊClosed studies with patients still being followed – Expedited versus Full Board
CALGB Data Audit Committee
INFORMED CONSENT
ÊAll required content present (refer to NCI required consent elements checklist) ÊOne risk omittedMAJOR ÊOriginal, signed, witnessed, and dated on or before date of registration
CALGB Data Audit Committee
3
INFORMED CONSENT
ÊEvidence of understanding -interpreter if not mentally competent or non-English speaking ÊAll blanks completed (e.g., contact numbers, MD names, etc.) when patient signs the consent
CALGB Data Audit Committee
ELIGIBILITY
ÊSource documents for each eligibility criterion support the data submitted (including hx of prior Rx or disease; documentation of appropriate PS) ÊPre-Rx diagnostics accurate & obtained within required time frames; concurrence with path diagnosis if required
CALGB Data Audit Committee
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ELIGIBILITY
ÊPt declared ineligible if requirements not present ÊAccurate ht/wt (ideal vs. real as specified per protocol) and BSA
CALGB Data Audit Committee
TREATMENT
ÊBSA accurate; recalculated each cycle if specified in protocol ÊRx doses & dates accurate & in concordance with protocol; no prohibited medications/Rxs ÊDocumentation of Rx administration, including oral agents & protocol-specific supportive Rxs
CALGB Data Audit Committee
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TREATMENT
ÊDose reductions, escalations or delays justified by the protocolanddocumented in MD/RN notes and flowsheets ÊInterim pt monitoring conducted according to protocol (labs, restaging diagnostics, etc.)
CALGB Data Audit Committee
TOXICITY
ÊAll toxicities recorded in chart reported on data forms; accurately graded ÊAdverse event procedures followed as required (accurate, complete data provided to study officials; timeliness of reporting) ÊPatient death within 30 days of Rx reported appropriately (even ifafterRx completed)
CALGB Data Audit Committee
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RESPONSE
ÊMeasurements are verifiable & obtained at appropriate time points ÊSame method of measurement at each interval ÊResponse/progression reported is accurate site ÊAllsof disease followed & recorded as required
CALGB Data Audit Committee
FOLLOW-UP
ÊPts off-Rx but not off-study are followed at intervals required by protocol ÊRequired follow-up exams & diagnostics completed (e.g., annual mammograms, gyn exams, etc.) & reported as required
CALGB Data Audit Committee
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FOLLOW-UP
ÊFollow-up forms & reports are current (progression or other endpoint event not reported within 6 months is a Major deviation)
CALGB Data Audit Committee
RECORDS AND DATA QUALITY
ÊHospital/clinic charts in concordance with submitted data ÊTreatment started within required time frame after entry (CALGB requires Rx to start within 7 days of registration) ÊFlow sheets ,if required, complete and accurate reflection of records
CALGB Data Audit Committee
8
RECORDS AND DATA QUALITY
ÊForms submitted within time frames ÊRecords are legible and reasonably well-organized ÊRequired submissions complete (e.g., slides, blocks, RT materials, serum samples) and utilized LabTrak
CALGB Data Audit Committee
LabTrak
ÊVerify sample submissions on all registered patients ÊIf checked periodically, then no surprises day of audit ÊNo path submissionMAJOR
CALGB Data Audit Committee
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CTSU Audits
ÊDone by CALGB if CALGB given credit for registration ÊPerformed on all 3 areas – IRB/Consent Content Pharmacy Patient Case Review
CALGB Data Audit Committee
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