Drug Procurement and Accountability

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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 [phone]
• Fax [phone]

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Commercially Available Products

• Supplied free of charge through pharmaceutical
  support
• OR
• Obtained via prescription from the physician
• Usually covered by patients 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