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Audit Prep Workshop 6.07,P&P.PPT

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12 pages
CALGB DATA AUDITPolicies and ProceduresSusan Tuttle, R.N.Audit Committee Vice-ChairCALGB Audit Preparation Workshop, November 2008CALGB Audit Committee For CALGB Participants Only Slide 3ÊÊÊÊÊÊRegulatory ComplianceIRB review/approval required before entryAnnual review at least every 12 months or <365 daysAll updates reviewed as required within 90 days of implementation/distributionCALGB Audit Committee For CALGB Participants Only Slide 5Regulatory ComplianceBroadcast SAEs submitted to IRB within 90 days of distribution UNLESS institution has policy/SOPs for handling differently than within 90 daysAction Letters acknowledged by IRB within 90 days of distributionAudit update and broadcast SAE list on web (resources → audit)CALGB Audit Committee For CALGB Participants Only Slide 6ÊÊÊÊRegulatory ComplianceParticipant notification accomplished as indicatedIRB informed of local AEs and appropriate reporting of serious Adverse Events reported to NCI via AdEERSCALGB Audit Committee For CALGB Participants Only Slide 7Regulatory ComplianceAdditional ReviewsCompanion studies Closed studies with patients still being followed – Expedited versus Full BoardCALGB Audit Committee For CALGB Participants Only Slide 8ÊÊÊÊRegulatory ComplianceSuspension of local enrollment due to new or modified risk information (i.e., 40302)The Central Office will indicate on update cover page when local suspension of enrollment is required ...
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CALGB DATA AUDIT
Policies and Procedures Susan Tuttle, R.N. Audit Committee Vice-Chair
CALGB Audit Preparation Workshop, November 2008
CALGB Audit Committee
For CALGB Participants Only
Slide 3
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/distribution
CALGB Audit Committee
For CALGB Participants Only
Regulatory Compliance
ÊBroadcast SAEs submitted to IRB within 90 days of distributionUNLESSinstitution has policy/SOPs for handling differently than within 90 days ÊAction Letters acknowledged by IRB within 90 days of distribution ÊAudit update and broadcast SAE list on web (resourcesaudit)
CALGB Audit Committee
For CALGB Participants Only
Slide 5
Slide 6
Regulatory Compliance
ÊParticipant notification accomplished as indicated ÊIRB informed of local AEs and appropriate reporting of serious Adverse Events reported to NCI via AdEERS
CALGB Audit Committee
For CALGB Participants Only
Regulatory Compliance
Additional Reviews ÊCompanion studies ÊClosed studies with patients still being followed – Expedited versus Full Board
CALGB Audit Committee
For CALGB Participants Only
Slide 7
Slide 8
Regulatory Compliance
ÊSuspension of local enrollment due to new or modified risk information (i.e., 40302) ÊThe Central Office will indicate on update cover page when local suspension of enrollment is required. CTEP issued memo on 3/20/08 (OHRP and FDA were included in memo) regarding instances where changes in risk may result in suspension until IRB approval and revised consent obtained. CALGB Audit Committee For CALGB Participants Only Slide 9
Consent Content
ÊProvide most recently IRB approved consent form for consent content review ÊAll required content present (refer to NCI required consent elements checklist) – best to duplicate CALGB model consent
CALGB Audit Committee
For CALGB Participants Only
Slide 10
Consent Content
ÊOne risk omittedMAJOR ÊOptions/alternatives or other choices of treatment or no treatment section of local consent form must be the same as the CALGB model consentUNLESSthe Central Office has approved different wordingMAJOR
CALGB Audit Committee
For CALGB Participants Only
Informed Consent
ÊOriginal, signed, witnessed, and dated on or before date of registration ÊPatient should date own signature ÊPatient should have signed the correct updated consent form
CALGB Audit Committee
For CALGB Participants Only
Slide 11
Slide 12
Informed Consent
ÊEvidence of understanding -interpreter if not mentally competent or non-English speaking ÊAll blanks completed (i.e., contact numbers, MD names, etc.) when patient signs the consent ÊTissue/blood submission patient option matches PCO report on tumor/tissue/blood receipt
CALGB Audit Committee
For CALGB Participants Only
Eligibility
Slide 13
ÊSource documents for each eligibility criteria 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 Audit Committee
For CALGB Participants Only
Slide 14
Eligibility
ÊPt declared ineligible if specific requirements not present ÊAccurate height and weight (ideal vs. real as specified per protocol) and BSA noted in patient chart
CALGB Audit Committee
For CALGB Participants Only
Treatment
Slide 15
ÊBSA accurate; recalculated each cycle if specified/instructed 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 Audit Committee
For CALGB Participants Only
Slide 16
Treatment
ÊDose reductions, escalations or delays justified by the protocoland documented in MD/RN notes and flowsheets ÊInterim pt monitoring conducted according to protocol (labs, restaging diagnostics, etc.)
CALGB Audit Committee
For CALGB Participants Only
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 Audit Committee
For CALGB Participants Only
Slide 17
Slide 18
Response
ÊMeasurements are verifiable & obtained at appropriate time points ÊSame method of measurement at each interval ÊResponse/progression reported is accurate ÊAllsitesof disease followed & recorded as required
CALGB Audit Committee
For CALGB Participants Only
Follow-Up
Slide 19
ÊPts off-Rx (but not off-study) are followed at intervals required by protocol ÊRequired follow-up exams & diagnostics completed (i.e., annual mammograms, gyn exams, etc.) & reported as required
CALGB Audit Committee
For CALGB Participants Only
Slide 20
Follow-Up
ÊFollow-up forms & reports are current ÊProgression or other endpoint event not reported within 6 months is considered aMAJORdeviation
CALGB Audit Committee
For CALGB Participants Only
Records and Data Quality
Slide 21
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 unless stated otherwise) ÊFlow sheets ,if required, complete and accurate reflection of records
CALGB Audit Committee
For CALGB Participants Only
Slide 22
Records and Data Quality
ÊForms submitted within required time frames ÊRecords are legible and reasonably well-organized ÊRequired submissions complete (i.e., slides, blocks, RT materials, serum samples) and utilized LabTrak
CALGB Audit Committee
For CALGB Participants Only
LabTrak
ÊTo be replaced with Specimen Tracking System ÊVerify sample submissions on all registered patients ÊIf checked periodically, then no surprises day of audit ÊNo path submissionMAJORdeviation
CALGB Audit Committee
For CALGB Participants Only
Slide 23
Slide 24
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