Notes
Slide Show
Outline
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Drug Procurement and Accountability
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Drug Supply Sources
  • Pharmaceutical Companies
  • NCI
  • Commercially available products
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Pharmaceutical Company Supplied Drug Procurement
  • Procedure varies by study.
  • Detailed instructions for obtaining drug can be found in Section 7.0 of the protocol
  • First step usually requires faxing the Study Agent Shipment Form (SASF) to CTSU (US) or RTOG (Canada).
    • RTOG Processing of this form approves the site as eligible to receive drug
    • Registration/Randomization is generally the trigger for the initial shipment
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Pharmaceutical Company Supplied Drug Procurement
  • Realistic Treatment Start Dates
    • If the SASF has already been processed, drug is generally shipped for overnight or two day delivery.
    • Most distributors will not ship prior to a weekend or holiday.
    • Shipments are limited between December 23 and January 1.

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Pharmaceutical Company Supplied Drug Procurement
  • Submitting your SASF for processing as soon as the individual responsible for the drug at your institution has been identified will assist you in:
    • avoiding delays in the initial drug shipment
    • alleviating frustration and inconvenience for yourself and most importantly the patient
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NCI
  • NCI sponsored studies


    • The Pharmaceutical Management Branch (PMB) of the NCI is responsible for supplying study agent for NCI trials.
    • NIH Form 986/Clinical Drug Request is used to order study drug for NCI sponsored trials
    • All NCI Forms are available on the NCI website at http://ctep.cancer.gov/requisition/storage.html
      • Clinical Drug Request
      • Investigational Agent Accountability Record
      • Drug Return
      • Drug Transfer


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NCI
  • Investigators must be registered with the
  • NCI and have an Investigator NCI Number to
  • receive drug from the NCI.
  • This requires the annual submission of:
    • FDA 1572 with CVs
    • signed Supplemental Investigator Data Form (IDF)
    • Financial Disclosure Form
  • NCI/PMB Contact Information:
  • Phone: (301) 496-5725
  • Fax: (301) 402-0429
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Commercially Available Products

    • Supplied free of charge through pharmaceutical support


          •    OR

    • Obtained via prescription from the physician


      • Usually covered by patient’s prescription plan


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Investigational Drug Sponsors & Support
  • NCI
  • ACR/RTOG
  • Pharmaceutical Companies
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Drug Accountability
  • Varies by sponsor/protocol
  • Records of accountability documentation
    • Receipt of Drug
    • Dispensation of Drug
    • Disposition of Drug (returned/destroyed used/unused)
      • Instructions usually documented in the protocol