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CCOP, MBCCOP & Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution. Mimi Passarello, M.B.A. NSABP, Pittsburgh, PA. NSABP Trials – Resources for Protocol-Specific Drug Accountability. Protocol* Protocol-Related Documents Fact Sheet*

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CCOP, MBCCOP & Research BasePrincipal Investigator and Administrator MeetingBreakout Session: Drug Distribution

Mimi Passarello, M.B.A.

NSABP, Pittsburgh, PA

nsabp trials resources for protocol specific drug accountability
NSABP Trials – Resources for Protocol-Specific Drug Accountability
  • Protocol*
  • Protocol-Related Documents
    • Fact Sheet*
    • Nurse/CRA Guidelines
what auditors review
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
what auditors review con t
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
what auditors review con t1
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)
major drug accountability issues nsabp sees on audit
“Major” Drug Accountability IssuesNSABP 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

“Lesser” Drug Accountability Issues NSABP sees on Audit:

  • “Write-overs”, changes not initialed
  • Math errors corrected during audit
  • Late return of drug
  • Blanks, incomplete headings
some nsabp protocols allow shipment to patient double blind tamoxifen
Some NSABP Protocols allow shipment to patient(double blind, tamoxifen)
  • Oral agents, stable at room temperature
  • Patients on long-term treatment
  • Intensive, frequent on-site follow-up not required
  • Patient-specific labeling on bottles
  • Controlled ordering through NSABP Biostatistical Center
newer issues
Newer Issues
  • Double blind studies only – patient returns of IND agents are recorded on log
  • Master logs highly recommended by NSABP for double blind studies
avoiding problems
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
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


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)