03-Audit P&P-Tuttle.PPT

Ckcolligan

Description

??????CALGB Data Audit: Relevant Elements from Policies and ProceduresSusan Tuttle, R.N.Vice Chair, Audit CommitteeCALGB Audit Preparation Workshop, June 2007For CALGB Participants OnlyCALGB Data Audit CommitteeREGULATORY REGULATORY COMPLIANCE COMPLIANCEIRB review/approval Broadcast SAEs acknowledged required before entry by IRB within 90 days of distributionAnnual review at least every 12 months or <365 Action Letters acknowledged by days IRB within 90 days of distributionAll updates reviewed as required within 90 days of Audit update and broadcast SAE implementation/distribution list on web (resources → audit)CALGB Data Audit Committee CALGB Data Audit Committee1?????????REGULATORY REGULATORY COMPLIANCE COMPLIANCEParticipant notification Additional Reviewsaccomplished as Companion studies indicated Closed studies with IRB informed of local patients still being AERs (C-804, Medwatch followed – Expedited Addendum) versus Full BoardCALGB Data Audit Committee CALGB Data Audit CommitteeINFORMED CONSENT INFORMED CONSENTAll required content present Evidence of understanding -(refer to NCI required consent interpreter if not mentally elements checklist) competent or non-English speaking One risk omitted → MAJORAll blanks completed (e.g., Original, signed, witnessed, contact numbers, MD names, and dated on or before date of etc.) when patient signs the registrationconsentCALGB Data Audit Committee CALGB Data Audit ...

Informations

• Publié par: Motheg
• Nombre de lectures: 29
• Langue: English

Extrait

CALGB Data Audit: Relevant Elements from Policies and Procedures

Susan Tuttle, R.N. Vice Chair, Audit Committee

CALGB Audit Preparation Workshop, June 2007

For CALGB Participants Only

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 o implementation/distribution

CALGB Data Audit Committee

CALGB Data Audit Committee

REGULATORY COMPLIANCE

Ê Broadcast SAEs acknowledged by IRB within 90 days of distribution Ê acknowledged byAction Letters IRB within 90 days of distribution Ê Audit update and broadcast SAE list on web (resources→audit)

CALGB Data Audit Committee

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REGULATORY COMPLIANCE

Ê Participant notification accomplished as indicated Ê IRB informed of local AERs (C-804, Medwatch Addendum)

CALGB Data Audit Committee

INFORMED CONSENT

Ê All required content present (refer to NCI required consent elements checklist) Ê One risk omitted→MAJOR Ê Original, signed, witnessed, and dated on or before date of registration

CALGB Data Audit Committee

REGULATORY COMPLIANCE

Additional Reviews Ê Companion studies Ê Closed studies with patients still being followed – Expedited versus Full Board

CALGB Data Audit Committee

INFORMED CONSENT

Ê Evidence of understanding - interpreter if not mentally competent or non-English speaking Ê All blanks completed (e.g., contact numbers, MD names, etc.) when patient signs the consent

CALGB Data Audit Committee

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ELIGIBILITY

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

CALGB Data Audit Committee

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

CALGB Data Audit Committee

ELIGIBILITY

Ê Pt declared ineligible if requirements not present Ê Accurate ht/wt (ideal vs. real as specified per protocol) and BSA

CALGB Data Audit Committee

TREATMENT

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

CALGB Data Audit Committee

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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 ifafter Rx completed) CALGB Data Audit Committee

FOLLOW-UP

Ê Pts off-Rx but not off-study are followed at intervals required by protocol Ê Required follow-up exams and diagnostics completed (e.g., annual mammograms, gyn exams, etc.) and reported as required

CALGB Data Audit Committee

RESPONSE

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

CALGB Data Audit Committee

FOLLOW-UP

Ê Follow-up forms and reports are current (progression or other endpoint event not reported within 6 months is considered a Major deviation)

CALGB Data Audit Committee

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RECORDS AND DATA QUALITY

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 Data Audit Committee

LabTrak

Ê Verify sample submissions on all registered patients Ê If checked periodically, then no surprises day of audit Ê No path submission→MAJOR deviation

CALGB Data Audit Committee

RECORDS AND DATA QUALITY

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

CALGB Data Audit Committee

CTSU Audits

Ê Done by CALGB if registration credit given to CALGB Ê Performed on all 3 areas – IRB/Consent Content Pharmacy Patient Case Review

CALGB Data Audit Committee

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CALGB Data Audit Committee

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