Audit Prep Workshop 6.07,P&P.PPT

Ckcolligan

Description

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 ...

Informations

• Publié par: Sawyog
• Nombre de lectures: 37
• Langue: English

Extrait

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

Ê IRB review/approval required before entry Ê Annual review at least every 12 months or <365 days Ê All updates reviewed as required within 90 days of implementation/distribution

CALGB Audit Committee

For CALGB Participants Only

Regulatory Compliance

Ê Broadcast SAEs submitted to IRB within 90 days of distributionUNLESSinstitution has policy/SOPs for handling differently than within 90 days Ê Action Letters acknowledged by IRB within 90 days of distribution Ê Audit update and broadcast SAE list on web (resources→audit)

CALGB Audit Committee

For CALGB Participants Only

Slide 5

Slide 6

Regulatory Compliance

Ê Participant notification accomplished as indicated Ê IRB 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 Ê Companion studies Ê Closed studies with patients still being followed – Expedited versus Full Board

CALGB Audit Committee

For CALGB Participants Only

Slide 7

Slide 8

Regulatory Compliance

Ê Suspension of local enrollment due to new or modified risk information (i.e., 40302) Ê The 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

Ê Provide most recently IRB approved consent form for consent content review Ê All 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

Ê One risk omitted→MAJOR Ê Options/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 wording→MAJOR

CALGB Audit Committee

For CALGB Participants Only

Informed Consent

Ê Original, signed, witnessed, and dated on or before date of registration Ê Patient should date own signature Ê Patient should have signed the correct updated consent form

CALGB Audit Committee

For CALGB Participants Only

Slide 11

Slide 12

Informed Consent

Ê Evidence of understanding -interpreter if not mentally competent or non-English speaking Ê All blanks completed (i.e., contact numbers, MD names, etc.) when patient signs the consent Ê Tissue/blood submission patient option matches PCO report on tumor/tissue/blood receipt

CALGB Audit Committee

For CALGB Participants Only

Eligibility

Slide 13

Ê Source documents for each eligibility criteria support the data submitted (including hx of prior Rx or disease; documentation of appropriate PS) Ê Pre-Rx diagnostics accurate & obtained within required time frames; concurrence with path diagnosis if required

CALGB Audit Committee

For CALGB Participants Only

Slide 14

Eligibility

Ê Pt declared ineligible if specific requirements not present Ê Accurate 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

Ê BSA accurate; recalculated each cycle if specified/instructed in protocol Ê Rx doses & dates accurate & in concordance with protocol; no prohibited medications/Rxs Ê Documentation of Rx administration, including oral agents & protocol-specific supportive Rxs

CALGB Audit Committee

For CALGB Participants Only

Slide 16

Treatment

Ê Dose reductions, escalations or delays justified by the protocoland documented in MD/RN notes and flowsheets Ê Interim pt monitoring conducted according to protocol (labs, restaging diagnostics, etc.)

CALGB Audit Committee

For CALGB Participants Only

Toxicity

Ê All toxicities recorded in chart reported on data forms; accurately graded Ê Adverse event procedures followed as required (accurate, complete data provided to study officials; timeliness of reporting) Ê Patient death within 30 days of Rx reported appropriately (even ifafterRx completed)

CALGB Audit Committee

For CALGB Participants Only

Slide 17

Slide 18

Response

Ê Measurements are verifiable & obtained at appropriate time points Ê Same method of measurement at each interval Ê Response/progression reported is accurate Ê Allsitesof disease followed & recorded as required

CALGB Audit Committee

For CALGB Participants Only

Follow-Up

Slide 19

Ê Pts off-Rx (but not off-study) are followed at intervals required by protocol Ê Required 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

Ê Follow-up forms & reports are current Ê Progression 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

Ê Hospital/clinic charts in concordance with submitted data Ê Treatment started within required time frame after entry (CALGB requires Rx to start within 7 days of registration unless stated otherwise) Ê Flow sheets ,if required, complete and accurate reflection of records

CALGB Audit Committee

For CALGB Participants Only

Slide 22

Records and Data Quality

Ê Forms submitted within required time frames Ê Records are legible and reasonably well- organized Ê Required submissions complete (i.e., slides, blocks, RT materials, serum samples) and utilized LabTrak

CALGB Audit Committee

For CALGB Participants Only

LabTrak

Ê To be replaced with Specimen Tracking System Ê Verify sample submissions on all registered patients Ê If checked periodically, then no surprises day of audit Ê No path submission→MAJORdeviation

CALGB Audit Committee

For CALGB Participants Only

Slide 23

Slide 24