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CCOP, MBCCOP Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution

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CCOP, MBCCOP Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution

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    1. CCOP, MBCCOP & Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution Mimi Passarello, M.B.A. NSABP, Pittsburgh, PA

    5. NSABP Trials – Resources for Protocol-Specific Drug Accountability Protocol* Protocol-Related Documents Fact Sheet* Nurse/CRA Guidelines

    6. What Auditors Review Drug Accountability Record Form (DARF) DARFs (or NCI-approved logs) are present for all investigational agents Logs are completely and correctly filled out Separate form for each agent / protocol / dosage form / dosage strength Logs for all satellites

    7. What Auditors Review (con’t) Storage and Stability Balance on the DARF matches the physical inventory and/or discrepancies are accounted for All study drugs are stored securely in a separate, limited-access area (at appropriate temperatures) Expired drugs are disposed of or returned Unused drug on closed studies has been transferred properly to open protocols or has been returned

    8. What Auditors Review (con’t) Tracking and Disposition Shipping receipts, transfer forms and drug return forms for each drug are on file Destruction records are on file Able to follow drug from shipment to patient (including dates)

    9. NSABP Pharmacy/Drug Accountability Audit Results June 1, 2006 – May 31, 2007

    10. “Major” Drug Accountability Issues NSABP Sees on Audit Use of commercial agent when agent is supplied Patient / insurance charged in error Cost to site Do not replace commercial agent with investigational Shipping of agents between sites NCI logs not in use for PMB-supplied agents and/or use specified in protocol; particularly problematic for double-blind trials No log for small offices

    12. Some NSABP Protocols allow shipment to patient (double blind, tamoxifen)

    13. Newer Issues

    14. Avoiding Problems Conduct periodic audits of pharmacies Communication with pharmacist regarding study-specific information Read protocol and protocol-related documents Avoid re-writing messy drug logs

    15. Audit Program CTMB Guidelines Presentation and Audit Deficiencies, provided by the Clinical Trials Monitoring Branch 3/07 CTMB Audit Deficiency Examples Guidelines for Monitoring of Clinical Trials for Cooperative Groups (PowerPoint) Site Visit Audit News (01/11/2007) Audit Program Description (07/17/2007) Examples of Audit Deficiencies (06/19/2007) Sample of Notification Letter (Treatment) (07/17/2007) Sample of Notification Letter (Prevention) (07/17/2007) Sample of Final Report (Treatment) Sample of Final Report (Prevention)

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